cost recovery implementation statement 2016-17 · cost recovery implementation statement 2016-17...

Cost recovery implementation statement 2016-17

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Therapeutic Goods Administration

Cost recovery implementation statement 2016-17V1.0 June 2016

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Copyright © Commonwealth of Australia 2016 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>.

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ContentsIntroduction ___________________________________ 5

Purpose of the Cost Recovery Implementation Statement _______________ 5

Description of the activity ______________________________________________________ 5

Outcome 5: Regulation, Safety and Protection -----------------------------------------5

Risk management approach -----------------------------------------------------------------5

Industry groups __________________________________________________________________ 6

Policy and statutory authority to cost recover_______ 6

Cost recovery model____________________________ 7Outputs and business processes of the activity ____________________________ 7

1. Prescription medicines --------------------------------------------------------------------7

2. Over the counter medicines ------------------------------------------------------------ 10

3. Complementary medicines ------------------------------------------------------------- 11

4. Medical devices ----------------------------------------------------------------------------- 12

5. Good manufacturing practices --------------------------------------------------------- 16

6. Blood, blood components and biologicals ----------------------------------------- 17

Design of cost recovery charges_________________ 19Costs of TGA activities _________________________________________________________ 19

Fees and charges ------------------------------------------------------------------------------ 19

Financial and non-financial performance __________ 21a) Financial performance_____________________________________________________ 21

b) Non- financial performance ______________________________________________ 22

Fees and charges and other reforms _____________ 23a) Annual charges exemption scheme _____________________________________ 23

b) Review of medicines and medical devices regulation _______________ 23

Risk assessment ______________________________ 24

Stakeholder engagement _______________________ 25

Key forward events ____________________________ 25Portfolio charging review ____________________________________________________ 25

CRIS approval and change register_______________ 26

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Design of cost recovery charges

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Costs of TGA activities

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Financial and non

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b) Non

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Fees and charges and other reforms

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a) Annual charges exemption scheme

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a) Annual charges exemption scheme

b) Review of medicines and medical devices regulation

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b) Review of medicines and medical devices regulation

Risk assessmentHistoric

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Risk assessment

Stakeholder engagementHistoric

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Stakeholder engagement

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blood components and biologicalsdocumen

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Design of cost recovery chargesdocumen

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Appendix 1 - Financial performance by industry sector group _______________________________________ 27

1. Prescription medicines ____________________________________________________ 27

2. Over the counter medicines _______________________________________________ 283. Complementary medicines ________________________________________________ 294. Medical devices, including in-vitro diagnostic (IVD) devices _______ 305. Good manufacturing practices____________________________________________ 316. Blood, blood components and biologicals ______________________________ 327. Other activities ______________________________________________________________ 33

Appendix 2 - Schedule of fees and charges w.e.f 1.7.2016_____________________________________________ 34

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Schedule of fees and charges w.e.f 1.7.2016

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Introduction

Purpose of the Cost Recovery Implementation StatementThis Cost Recovery Implementation Statement (CRIS) provides information on how the Therapeutic Goods Administration (TGA) implements cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices, including in vitro diagnostic (IVD) devices, and biologicals onto the Australian Register of Therapeutic Goods (ARTG) and the ongoing monitoring and surveillance of them.

Description of the activityThe TGA is a part of the Department of Health and contributes to Outcome 5 as outlined in the 2016-17 Portfolio Budget Statements:

Outcome 5: Regulation, Safety and Protection Protection of the health and safety of the Australian community and preparedness to respond to national health emergencies and risks, including through immunisation, initiatives, and regulation of therapeutic goods, chemicals, gene technology, and blood and organ products.

5.1: Protect the Health and Safety of the Community through Regulation The Government aims to provide a world class, efficient and timely regulatory system for therapeutic goods. In 2016-17, the TGA will continue to promote best practice regulation through business improvement and regulatory reform, while meeting the Australian Government’s expectations under the Regulator Performance Framework.

To achieve this outcome, the TGA approves and regulates products based on an assessment of risks against benefits. The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries. The TGA regulates therapeutic goods through:

• pre-market assessment;

• post-market monitoring and enforcement of standards; and

• licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.

Therapeutic goods are divided broadly into 3 classes: medicines, medical devices and biologicals. Medicines must be entered as either 'registered' or 'listed' medicines on the ARTG. Medical devices and biologicals must be 'included' on the ARTG before they may be supplied in or exported from Australia, unless exempted.

If a problem is discovered with a medicine, device, biological or manufacturer, the TGA is able to take action. Possible regulatory actions vary from continued monitoring to withdrawing the product from the market and revoking or cancelling a manufacturing licence.

Risk management approachAll therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk. The level of regulatory control increases with the level of risk a medicine or medical device can pose. The risk-benefit approach assures consumers that

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To achieve this outcome, the TGA approves and regulates products based on an assessment of

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al risks against benefits. The Australian community expects therapeutic goods in the marketplace

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al unity expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries. The

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al to be safe, of high quality and of a standard at least equal to that of comparable countries. The TGA regulates therapeutic goods through:

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market assessment;

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licensing of Australian manufacturers and verifying overseas manufacturers' compliance

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Therapeutic goods are divided broadly into 3 classes: medicines, medical devices and

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Therapeutic goods are divided broadly into 3 classes: medicines, medical devices and biologicals.

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biologicals. Medicines must be entered as either 'registered' or 'listed' medicines on the

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Medicines must be entered as either 'registered' or 'listed' medicines on theMedical devices and biologicals must be 'included' on the ARTG before they may be supplied in

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Medical devices and biologicals must be 'included' on the ARTG before they may be supplied in or exported from Australia, unless exempted.

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or exported from Australia, unless exempted.

If a problem is discovered with a medicine, device, biological or manufacturer, the TGA is able to Historic

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If a problem is discovered with a medicine, device, biological or manufacturer, the TGA is able to take action. Possible regulatory actions vary from continued monitoring to withdrawing the Hist

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product from the market

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ts a part of the Department of Health and contributes to Outcome 5 as outlined in the

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ts a part of the Department of Health and contributes to Outcome 5 as outlined in the

Protection of the health and safety of the Australian community and preparedness to respond to

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tProtection of the health and safety of the Australian community and preparedness to respond to national health emergencies and risks, including through immunisation, initiatives, and

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tnational health emergencies and risks, including through immunisation, initiatives, and regulation of therapeutic goods, chemicals, gene technology, and blood and organ products.

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regulation of therapeutic goods, chemicals, gene technology, and blood and organ products.

5.1: Protect the Health and Safety of the Community through Regulation

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5.1: Protect the Health and Safety of the Community through RegulationThe Government aims to provide a world class, efficient and timely regulatory system for

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The Government aims to provide a world class, efficient and timely regulatory system for will continue to promote best practice regulation docu

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ulatory reform, while meetingGovernment’s expectations under the Regulator Performance Frameworkdocu

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Government’s expectations under the Regulator Performance Framework



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the products they take are safe for their intended use, while still providing access to products that are essential to their health needs.

Industry groupsThe TGA’s cost recovery arrangements cover the following industry sectors:

• Prescription medicines

• Over the counter medicines

• Complementary medicines

• Medical devices, including in- vitro diagnostic (IVD) devices

• Good manufacturing practices

• Blood, blood components and biologicals

While some funding is provided to the TGA by the Government in the form of an interest equivalency payment against the special account balance (reserves), the bulk of funding is generated through fees and charges charged under cost recovery arrangements.

Policy and statutory authority to cost recoverWhere specific demand for a government activity is created by identifiable individuals or groups, they should be charged for it unless the government has decided to fund that activity. Where it is appropriate for the Australian Government to participate in an activity, it should fully utilise and maintain public resources, through appropriate charging. The application of charging should not, however, adversely impact disadvantaged Australians.1 The Australian Government’s overarching cost recovery policy is that, where appropriate, non-government recipients of specific government activities should be charged some or all of the costs of those activities. The cost recovery policy promotes consistent, transparent and accountable charging for government activities and supports the proper use of public resources2.

Cost recovery involves the government entities charging individuals or non-government organisations some or all of the efficient costs of a specific government activity. This may include goods, services or regulation, or a combination of these. The Australian Government Cost Recovery Guidelines (CRGs) set out the overarching framework under which government entities design, implement and review cost recovered activities.

In the 1997–98 Budget, Budget Paper No.2, Part II: Revenue Measures it was stated that the TGA would fully recover all costs from industry from 1998-99. As the TGA operates on a cost recovery basis, to enable pre- and post-market regulatory activity, there are a number of fees and charges for therapeutic goods. These include annual charges, application and evaluation fees, conformity assessment fees and inspection fees which are imposed on manufacturers of medicines and medical devices.

The Therapeutic Goods Act 1989 (the Act) provides a legal authority for the TGA to charge for its regulatory activities within the scope of the Act. The Therapeutic Goods (Charges) Act 1989 (the Charges Act) provides a legal authority to levy annual charges (a type of tax) on sponsors and

1 Australian Government Charging Framework, 2015, available at www.finance.gov.au. 2 Under the Public Governance, Performance and Accountability Act 2013 (PGPA Act), revenue from cost recovery is a public resource for both corporate and non-corporate Commonwealth entities. Section 8 of the PGPA Act defines ‘proper’ use or management of public resources as efficient, effective, economical and ethical.

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Government’s overarching cost recovery policy is that, where appropriate, non

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Cost recovery involves the government entities charging individuals or non

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In the 1997

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would fully r

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would fully recover all costs from industry from 1998

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ecover all costs from industry from 1998recovery basis, to enable pre

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manufacturers of medicines and medical devices. Applicable fees and charges are prescribed in the subordinate regulations made under these Acts.

Cost recovery model

Outputs and business processes of the activity

1. Prescription medicines Higher risk medicines, such as prescription medicines, must be registered on the ARTG before they are made available for sale in Australia.

Prescription medicines are available from a pharmacist, supplied with a doctor’s prescription. Otherwise, only authorised health care professionals can supply prescription medicines, such as in a hospital setting. Examples include vaccines, blood pressure tablets, diabetes medications, contraceptive pills, antibiotics and strong painkillers.

There are some legal exemptions to the requirement for a prescription medicine to be registered on the ARTG before they are supplied in Australia. These are implemented through:

• the Special Access Scheme (SAS); and

• the clinical trials systems (CTX and CTN)

The business area responsible for administering these exemptions ensures that they are administered in accordance with the legislative and regulatory frameworks.

As the TGA operates on a cost recovery basis, to enable pre- and post-market regulatory activity there are a number of fees and charges for medicines. These include annual charges, application fees and evaluation fees.

Regulatory framework Regulatory decisions are made within a framework of guidelines. The guidelines must maintain currency with scientific and technical developments.

International regulators, or regulator groups such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, may publish guidelines that are reviewed and may be adopted by the TGA.

Registration on the ARTG Before being placed on the ARTG, prescription medicines are assessed for quality, safety and efficacy. This utilises the following process.

Applications All applications for registration of prescription medicines must be preceded by a pre-planning submission form (PPF). TGA assesses all PPFs to ensure that application dossiers for registration on the ARTG contain all the appropriate and required information. The information provided in the PPF allows resources to be effectively assigned to the evaluation process. If the PPF is insufficient for planning purposes or indicates that mandatory requirements have not been met, the TGA may deem the PPF to be ‘not effective’ and the application will not proceed to the dossier submission stage. The submission of the PPF improves the quality of applications and helps in meeting legislative timeframes.

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al As the TGA operates on a cost recovery basis, to enable pre

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Regulatory decisions are made within a framework of

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al currency with scientific and technical deve

International regulators, or regulator groups such as the International Conference on

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al International regulators, or regulator groups such as the International Conference on

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al Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,

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al Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, may publish guidelines that are reviewed and may be adopted by the TG

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al may publish guidelines that are reviewed and may be adopted by the TG

Registration on the ARTG

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Before being placed

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placed on the ARTG

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on the ARTGefficacy.

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efficacy. This utilises the following process.

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This utilises the following process.

Applications

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ApplicationsAll applications for registration of prescription medicines must be precedeHist

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All applications for registration of prescription medicines must be precedesubmission form (PPF). TGA assesses all PPFs to ensure that application dossiers for registration Hist

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submission form (PPF). TGA assesses all PPFs to ensure that application dossiers for registration on the ARTG contain all the appropriate and required information. The information provided in Hist

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on the ARTG contain all the appropriate and required information. The information provided in

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tigher risk medicines, such as prescription medicines, must be registered on the ARTG before

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tigher risk medicines, such as prescription medicines, must be registered on the ARTG before

Prescription medicines are available from a pharmacist, supplied with a doctor’s prescription.

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de vaccines, blood pressure tablets, diabetes medications,

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There are some legal exemptions to the requirement for a prescription medicine to be registered

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. These are implemented through:

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The business area responsible for administering these exemptions ensures that they are

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The business area responsible for administering these exemptions ensures that they are administered in accordance with the legislative and regulatory frameworks.docu

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administered in accordance with the legislative and regulatory frameworks.

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Data evaluation The data submitted with an application is divided into three types.

• Quality data evaluated by chemists, biochemists, microbiologists and other TGA officers includes:

– the composition of the drug substance and the drug product

– batch consistency

– stability data

– sterility data (if applicable)

– the impurity content

– non-clinical data evaluated by toxicologists

– pharmacology data

• Toxicology data

• Clinical data evaluated by a medical doctor (mostly results of clinical trials)

Decision making Before making a decision around the suitability of a prescription medicine for registration on the ARTG, the delegate may take into consideration independent expert advice provided by the Advisory Committee on Prescription Medicines.

Regulatory decisions in relation to new chemical entities or fixed dose combination products are published through the Australian Public Assessment Report (AusPAR).

Any person whose interests are affected by the decision may seek a reconsideration of the decision under section 60 of the Act.

Applications to change details of registration Once a product has been registered, the sponsor can make further applications to change the details of registration. Some examples of the types of change that might be applied for include:

• a change in manufacturer;

• an increase in shelf-life;

• a change in patient population (e.g. allowing children to use the medicine); and

• changing the intended use (usually adding an extra medical condition that can be treated).

Changes may or may not require evaluation of data by the TGA and the prescribed fees apply accordingly.

Export Medicines for export from Australia must be of a similar quality and safety standard as those supplied domestically. However, they are not required to comply with the labelling standards or advertising standards in force in Australia. Export only products are required to be listed (not registered) on the ARTG before export.

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al Regulatory decisions in relation to new chemical entities or fixed dose combination products are

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al Regulatory decisions in relation to new chemical entities or fixed dose combination products are published through the Australian Public Assessment Report (AusPAR).

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al published through the Australian Public Assessment Report (AusPAR).

whose interests are affected by the decision may seek a reconsideration of the

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al whose interests are affected by the decision may seek a reconsideration of the decision under section 60 of the

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al decision under section 60 of the Act.

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Applications to change details of registration

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al Applications to change details of registrationOnce a product has been registered, the sponsor can make further applications to change the

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al Once a product has been registered, the sponsor can make further applications to change the details of registration. Some examples of the types of change that might be applied for include:

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changing the intended use

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Changes may or may not require evaluation of data by the TGA and the prescribed fees apply

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Before making a decision around the suitability of a prescription medicine for registration on the

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Special Access Scheme (SAS) In the circumstances where patients need access to therapeutic goods that are not on the ARTG, access to the therapeutic good may be arranged through the SAS.

TGA reviews each access under the SAS on a case-by-case basis.

Clinical trials TGA reviews the use of unapproved medicines to be made available to patients participating in a clinical trial.

Compliance monitoring and enforcement Post-market activities undertaken in relation to prescription medicines include:

• providing access to a comprehensive source of up-to-date consumer medicine information and product information;

• review of Periodic Safety Update Reports to ensure the ongoing suitability of products for registration on the ARTG;

• monitoring risk management plans that detail how safety concerns will be identified and mitigated post-registration;

• ensuring that regular post-market reports are received from sponsors;

• Monitoring any international concerns about a product’s safety or efficacy

• laboratory testing program on selected medicines, including random and targeted sampling of approved products;

• publishing a Medicines Safety Update in each edition of the Australian Prescriber;

• managing the problem reporting system for:

– medicine deficiency or defect

– adverse reaction to a medicine; and

• undertaking appropriate regulatory action for identified problems. Actions include:

– informing health care professionals and consumers about the risks of using the product;

– re-assessing the benefit-risk profile;

– requiring product labelling changes;

– requiring design or manufacturing change;

– requesting post-market studies;

– restricting access;

– recalling products; and

– removing the product from the ARTG. Hist

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ublishing a Medicines Safety Update in each edition of the Australian Prescriber

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al ublishing a Medicines Safety Update in each edition of the Australian Prescriber

anaging the problem reporting system for:

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ndertaking appropriate regulatory action

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informing health care professionals and consumers about the risks of using the product

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– requesting post

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date consumer medicine information

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eview of Periodic Safety Update Reports to ensure the ongoing suitability of products for

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onitoring risk management plans that detail how safety concerns will be identified and

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market reports are received from sponsors

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market reports are received from sponsors

Monitoring any international concerns about a product’s safety or efficacy

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ublishing a Medicines Safety Update in each edition of the Australian Prescriber



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2. Over the counter medicines Over the counter (OTC) medicines are defined in the Therapeutic Goods Regulations 1990 (the Regulations). OTC medicines can be supplied as pharmacy medicines, pharmacist-only medicines and general sales medicines. Registered OTC medicines are considered to be of lower risk than prescription medicines, but they require an appropriate level of scrutiny.

Medicines are grouped into schedules according to the appropriate level of regulatory control over their availability to consumers. OTC medicines can be purchased for self-treatment from pharmacies, with selected products also available in supermarkets, health food stores and other retailers. Examples include cough and cold remedies, anti-fungal treatments, sunscreens, non-prescription analgesics such as aspirin and paracetamol.

OTC medicines can be registered or listed on the ARTG depending on the level of risk associated with making the product available and accessible to consumers.

Registering an OTC medicine on the ARTG Registered OTC medicines are considered to be of relatively higher risk than listed OTC medicines, based on their substances or the indications made for the medicine. Registered medicines are evaluated for quality, safety and efficacy prior to being accepted on the ARTG and able to be marketed.

The pre-market regulatory process for OTC medicines includes:

• lodgement of an application for product registration or listing on the ARTG;

• administrative and technical screening;

• scientific evaluation;

• label assessment;

• ensuring appropriate GMP is in place;

• requesting advice from the Advisory Committee on non-prescription medicines;

• advising the sponsor of the outcome of the application process; and

• updating the ARTG.

Once a product has been registered, the sponsor can make further applications to change the details of registration. Examples of changes that may be sought include details related to labels, shelf-life, formulation, indications or directions for use.

Listing an OTC medicine on the ARTG The listing process for an OTC medicine is the same as listing a complementary medicine which is explained in the complementary medicines section of the CRIS.

Compliance monitoring and enforcement The OTC post-market regulatory processes include detection, compliance and enforcement:

• Detection

– undertaking laboratory testing of products (i.e. chemistry and microbiology);

– investigating reported adverse events; and

– reviewing the safety of products or classes of products.

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of 35

• Compliance

– monitoring compliance with regulations;

– maintaining product registers;

– ensuring compliance with advertising regulations;

– educating stakeholders;

– recalling products;

– issuing alerts to consumers; and

– updating product information.

• Enforcement

– investigating potential breaches; and

– enforcing the regulations.

3. Complementary medicinesMedicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Act. Complementary medicines may be either listed or registered, depending on their ingredients and claims made for the medicine. Most complementary medicines are listed on the ARTG.

Listing a complementary medicine on the ARTG Listed medicines are low risk medicines that are listed on the ARTG via a streamlined electronic listing facility. This process for listing products allows for early market access for low risk complementary medicines. At the time of submitting a listed medicine application, the sponsor must certify that the goods that are the subject of the application meet all of the regulatory requirements.

Unlike registered medicines, there is no evaluation prior to the medicine being listed on the ARTG. The TGA therefore uses a variety of other mechanisms to assure the safety and quality of complementary medicines, such as:

• they may only contain substances that have been previously evaluated and approved as being of low risk;

• they can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions;

• a proportion of listed complementary medicines are reviewed following their listing for compliance with the regulatory requirements; and

• additional substances or ingredients to be used in listed medicines may be evaluated and approved by the TGA on application from the industry. On average, there are 12 such applications received each year.

Registering a complementary medicine on the ARTG Registered complementary medicines are considered to be of relatively higher risk than listed complementary medicines, based on their substances or the indications made for the medicine.

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of 35

Registered medicines are fully evaluated for quality, safety and efficacy prior to being accepted on the ARTG and able to be marketed.

Compliance monitoring and enforcement The post-market compliance review of a listed complementary medicine involves:

• assessing information about the product against the relevant legislative requirements, including, where relevant, the certifications given by the sponsor at the time the product was listed; and

• taking appropriate actions when a breach of the legislative requirements is identified. This action may include cancellation of the listing of the medicine.

The compliance review of a listed complementary medicine may focus on one or several aspects of the medicine. Based on experience and the potential risk that non-compliance represents to the public, the TGA gives greater attention to the following three areas:

• the evidence that a sponsor holds to support the indications;

• the presentation of the medicine; and

• the advertising of the medicine.

On average, approximately 1,800 new complementary medicines are listed on the ARTG each year. Due to resource constraints, the TGA follows a risk management approach to set priorities and direct resources to those reviews that provide the greatest overall benefit for the Australian public. To assist with this determination the TGA gives priority to issues that:

• may result in immediate or potential health risk to consumers;

• could significantly mislead the Australian public, particularly in a way that could have a health impact

• are industry-wide or are likely to become widespread if the TGA does not take action;

• could lead to a loss of stakeholder confidence in regulation or in therapeutic goods;

• may attract adverse scrutiny from media or the public;

• are of national or international significance; and

• involve a new or emerging issue.

Depending on the circumstances, priority will also be given to products that have been relisted after a previous TGA-initiated cancellation or at the request of the sponsor after a previous compliance review, or where the risk or the characteristics of the medicine are of concern.

Listed complementary medicines with potential non-compliance issues may be brought to the TGA's attention from a number of sources, including the public, media, health care professionals or other external sources, referrals from within the TGA, information from other regulatory agencies and information from previous compliance reviews.

Finally, a proportion of newly listed medicines are randomly selected by computer, based on a mathematical model, for compliance review.

4. Medical devices The Australian medical devices regulatory framework sets out the requirements for the quality, safety and performance of medical devices, based on a series of Essential Principles, rather than

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https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd



of 35

a prescriptive framework. All medical devices must demonstrate compliance with the Essential Principles. The extent of evidence required to demonstrate compliance with the Essential Principles is based on the risk classification of the device, with higher risk devices undergoing greater assessment prior to being allowed into the Australian market.

Regulatory activities span the life cycle of the medical device, including:

• pre-market (such as applications to include medical devices on the ARTG, conformity assessment applications and use in clinical trials); and

• post-market (such as reporting of adverse events, undertaking recalls and reviewing advertising).

As the TGA operates on a cost recovery basis, to enable pre- and post-market regulatory activity, there are a number of fees and charges for medical devices. These include annual charges, application fees, conformity assessment fees and application audit fees.

Applications to include medical devices on the ARTG Under the Act, medical devices must be included on the ARTG prior to supply in Australia unless exempt from that requirement, such as exemption from complying with the standards under section 14 of the Act. The level of assessment conducted at the point of application for ARTG inclusion depends on the risk classification of the device, the conformity assessment evidence supporting the application, and whether there are any concerns with the application that would require the TGA to request further information for review prior to inclusion.

High-risk medical devices must have an ARTG entry for each unique device. Lower risk devices can have multiple similar devices included under one ARTG entry (a ‘kind of medical device’). As the application fee is payable per ARTG entry and the value of the fee is higher for higher risk medical devices, higher risk medical devices are associated with higher overall costs.

Approval for each medical device is exclusive to the sponsor applying for inclusion, approval for one sponsor cannot be used by other sponsors, even where the medical device is identical.

While all medical devices must comply with minimum requirements for quality, safety and performance, devices other than the lowest risk, must be accompanied by conformity assessment certification following an assessment of a manufacturer’s quality management system and assessment of design dossiers where applicable.

In addition to the conformity assessment certification accompanying an application for ARTG inclusion, the application process also involves a review of other information supplied with the application such as the labelling and instructions for use for the device.

Application audits Some applications for inclusion of medical devices on the ARTG will undergo an application audit.

• Applications to include certain medical devices in the ARTG must be selected for an application audit—for these mandatory audits an application audit assessment fee is charged.

• The TGA may also select any other application for inclusion for an application audit - an audit assessment fee is not charged for these audits.

There are two levels of application audit—Level 1 and Level 2 for non-IVD medical devices and one level of application audit for IVD medical devices. If an application audit is to be conducted the TGA determines what level of application audit is appropriate for each application. There are different fees for each level of application audit, which apply if the audit is mandatory.

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of 35

Conformity assessments A conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure that manufacturers of medical devices have systems and processes that provide assurance that the device conforms to the Essential Principles for quality, safety and performance.

A manufacturer must implement and maintain a post-market monitoring system for devices after supply, with reportable events reported as specified in the Regulations. A manufacturer’s quality system certification may be subject to periodic surveillance audits.

For the majority of medical devices and IVDs the TGA is able to accept the assessment of conformity assessment bodies that are considered to have the appropriate authority and expertise. As the Australian and the European Union (EU) regulatory requirements are similar, certificates issued by EU conformity assessment bodies (also known as Notified Bodies) may be accepted as conformity assessment evidence for the supply of devices in Australia.

For certain higher risk medical devices and IVDs, manufacturers must obtain Conformity Assessment Certificates from the TGA for supply to the market in Australia, regardless of whether they have a certificate issued by an EU notified body. In conducting assessments for these products, the assessment will take into account any existing EU conformity assessment evidence. This requirement for TGA conformity assessment applies to medical devices containing medicinal substances or materials of animal, microbial, recombinant or human origin and Class 4 IVDs. Manufacturers may also choose to seek conformity assessment certification from TGA to support supply of their medical devices in Australia, rather than relying on certification from an EU notified body.

Clinical trials There are two schemes under which clinical trials involving medical devices may be conducted.

• Clinical Trial Notification (CTN) Scheme—this involves a notification only with a nominal notification fee (no approval or decision is made by the TGA).

• Clinical Trial Exemption (CTX) Scheme—this process comprises an assessment of summary data and usage guidelines for a proposed clinical development programme, and if approval is granted the subsequent trials must be carried out under the terms of the approval and be notified to the TGA.

These schemes are used for clinical trials involving:

• any device not included in the ARTG; and

• use of a device in a clinical trial beyond the conditions of its marketing approval.

Other therapeutic goods listed and registered on the ARTG A large majority of medical devices listed and registered on the ARTG prior to 2002 (previously called therapeutic devices) have now been transitioned to the new regulatory framework and are now largely regulated under Chapter 4 of the Act. There is a small number of therapeutic devices which are not captured under the new Chapter 4 arrangements. These are largely disinfectants, tampons and menstrual cups. The fees and charges included in this document for registered and listed devices apply for these products.

Post-market vigilance and monitoring, and recalls Once a medical device has been included in the ARTG the device must continue to meet all the regulatory requirements that were required for the approval, including the requirements for safety, quality and performance.

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of 35

Post-market vigilance

The TGA has mandatory requirements for all manufacturers and sponsors of medical devices. These requirements are intended to monitor information about medical devices so that appropriate action can be taken. The requirements facilitate the systematic investigation of failures and/or deviations in the way a device performs, in an attempt to prevent an adverse event occurring again. Key post-market mechanisms include:

• Reportable events:

The TGA provides guidance as to the definition of a reportable adverse event for medical devices. There is mandatory reporting within statutory timeframes for sponsors and manufacturers of adverse events that have or could have caused a death, serious injury or serious illness and non-mandatory reporting for other events.

The outcomes of the investigations may result in recalls, hazard and safety alerts, product modification/improvement by a manufacturer, or surveillance audits of manufacturing sites.

Post-market monitoring

The TGA undertakes post-market reviews of ARTG entries of medical devices to verify compliance with the legislative requirements, such as conditions of inclusion, and to ensure continued safety and performance usually following signals that there may be an issue or a special interest in the device or a type of device.

Sponsors of Class III medical devices must also keep an up to date log of information about the performance of the device and provide annual reports for the first three years after a product receives market authorisation.

The TGA can take action to suspend or cancel a device from the ARTG where, for example, the outcomes of investigations indicate that there is a potential risk of death, serious illness or serious injury if the device continued to be included in the ARTG or if the TGA is satisfied, for instance, that the safety or performance of the device is unacceptable.

Recall actions

A recall action is an action taken to resolve a problem with therapeutic goods already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are three distinct recall actions - recall, recall for product correction and hazard alert. Not all recall actions result in a product being removed from the market, for example, hazard alerts may be issued in cases involving implantable medical devices, and corrections may be undertaken for products that have software issues.

The TGA coordinates approximately 500 recall actions of medical devices each year. The vast majority of recalls are undertaken voluntarily by the sponsor after consultation with the TGA. For each recall action, the Recalls Unit reviews the proposed recall strategy to address the health hazard and the individual circumstances of each case. Strategies need to reflect the kind of medical device, deficiency identified, risk posed by the deficiency, distribution networks, recovery procedures, resources for corrective action and availability of alternative products. In some cases, recall action is not required but the sponsor may be required to issue a safety alert or some precautionary information in the form of a product notification.

The Recalls Unit monitors the progress of recall action by reviewing the progress reports submitted by the sponsor. In the close-out report, sponsors should provide the root cause of the problem and remedial action undertaken by the manufacturer. The report is reviewed to ensure that the root cause and the corrective action identified are appropriate to prevent the issues from recurring.

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market, for example, hazard alerts may be issued in cases involving implantable medical devices,

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al market, for example, hazard alerts may be issued in cases involving implantable medical devices, and corrections may be undertaken for products that have software issues

Historic

al and corrections may be undertaken for products that have software issues

The TGA coordi

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al The TGA coordinates approximately 500 recall actions of medical devices each year. The vast

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al nates approximately 500 recall actions of medical devices each year. The vast

majority of recalls are undertaken voluntarily by the sponsor after consultation with the TGA.

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al

majority of recalls are undertaken voluntarily by the sponsor after consultation with the TGA.

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al

For each recall action, the Recalls Unit reviews the proposed recall strategy to ad

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al

For each recall action, the Recalls Unit reviews the proposed recall strategy to adhazard and the individual circumstances of each case. Strategies need to reflect the kind of

Historic

al

hazard and the individual circumstances of each case. Strategies need to reflect the kind of medical device, deficiency identified, risk posed by the deficiency, distribution networks,

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al

medical device, deficiency identified, risk posed by the deficiency, distribution networks, recovery procedures, resources for corrective action and availability of alternative products. In Hist

orical

recovery procedures, resources for corrective action and availability of alternative products. In some cases, recall action is not required but the sponsor may be required to issue a safety alert Hist

orical

some cases, recall action is not required but the sponsor may be required to issue a safety alert or some precautionary information in the form of a product notification.Hist

orical

or some precautionary information in the form of a product notification.

The Recalls Unit monitors the progress ofHistoric

al

The Recalls Unit monitors the progress of

documen

tThe TGA provides guidance as to the definition of a reportable adverse event for medical

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tThe TGA provides guidance as to the definition of a reportable adverse event for medical devices. There is mandatory reporting within statutory timeframes for sponsors and

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tdevices. There is mandatory reporting within statutory timeframes for sponsors and caused a death, serious injury or

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tcaused a death, serious injury or

The outcomes of the investigations may result in recalls, hazard and safety alerts, product

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tThe outcomes of the investigations may result in recalls, hazard and safety alerts, product modification/improvement by a manufacturer, or surveillance audits of manufacturing sites.

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tmodification/improvement by a manufacturer, or surveillance audits of manufacturing sites.

market reviews of ARTG entries of medical devices to verify

documen

tmarket reviews of ARTG entries of medical devices to verify

compliance with the legislative requirements, such as conditions of inclusion, and to ensure

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tcompliance with the legislative requirements, such as conditions of inclusion, and to ensure

usually following signals that there may be an issue or a

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tusually following signals that there may be an issue or a

Sponsors of Class III medical devices must also keep an up to date log of information about the

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t

Sponsors of Class III medical devices must also keep an up to date log of information about the performance of the device and provide annual reports for the first three years after a product

documen

t

performance of the device and provide annual reports for the first three years after a product

The TGA can take action to suspend or cancel a device from the ARTG where, for example, the documen

t

The TGA can take action to suspend or cancel a device from the ARTG where, for example, the outcomes of investigations indicate that there is a potential risk of death, serious illness or docu

ment

outcomes of investigations indicate that there is a potential risk of death, serious illness or serious injury if the device continued to be included in the ARTG or if the TGA is satisfied, for docu

ment

serious injury if the device continued to be included in the ARTG or if the TGA is satisfied, for



of 35

Advertising review TGA reviews advertisements for medical devices to ensure compliance with the conditions of inclusion on the ARTG that are detailed in the Regulations and the Therapeutic Goods Advertising Code (TGAC). These advertisements may be in, but are not limited to, broadcast and mainstream print media, billboards, cinema films or the internet.

Where a complaint about a product advertisement is received, TGA will assess the validity of the complaint and, if necessary, ensure that rectifying action is undertaken.

In its review of advertising, TGA works with the following stakeholders:

• therapeutic goods industry;

• health practitioners;

• consumers;

• advertising industry;

• Australian Competition & Consumer Commission;

• Medsafe (NZ therapeutic goods regulator);

• Media;

• Therapeutic Goods Advertising Code Council; and

• Complaints Resolution Panel.

Advertisements for medical devices do not have to be approved prior to publication or broadcast. However, advertisements must comply with the conditions of inclusion on the ARTG detailed in section 41FN(5) of the Act, Division 3 and 4, Part 2 of the Regulations and the TGAC.

The Complaints Resolution Panel considers complaints about advertisements for medical devices and other therapeutic goods appearing in broadcast and mainstream print media, billboards, cinema films, the internet etc. As advertisements do not require pre-approval, the majority of activity in this area is related to assessing the validity of complaints about current advertisements that are claimed as not meeting the requirements.

TGA does not charge for lodging a complaint with the Complaints Resolution Panel. To do so would be contrary to the intent of allowing all complaints about advertising to be appropriately examined. The costs of validating complaints are recovered from sponsors of medical devices via annual charges which are linked to the maintenance of the sponsor’s ARTG entry, spreading the cost of the function evenly across all products.

5. Good manufacturing practices In Australia, manufacturers of therapeutic goods are required to hold a licence, except for manufacturers of certain medical devices who have European conformity certification (CE Mark). To obtain the licence, a manufacturer must demonstrate that they have the ability to comply with manufacturing principles, which include relevant Codes of GMP and Quality Systems, and have appropriate facilities to manufacture safely. Overseas manufacturers of therapeutic goods supplied to Australia must provide evidence of compliance with equivalent GMP standards or otherwise undergo on-site inspections in the same manner as manufacturers based in Australia.

GMP is a generally accepted term internationally to describe a set of principles and procedures that, when followed by manufacturers of medicines and biologicals, helps to insure that the products manufactured will possess the required quality.

Historic

al The Complaints Resolution Panel considers complaints about advertisements for medical

Historic

al The Complaints Resolution Panel considers complaints about advertisements for medical devices and other therapeutic goods appearing in broadcast and mainstream print media,

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al devices and other therapeutic goods appearing in broadcast and mainstream print media, billboards, cinema films, the internet etc. As advertisements do not require pre

Historic

al billboards, cinema films, the internet etc. As advertisements do not require premajority of activity in this area is relate

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al majority of activity in this area is related to assessing the validity of complaints about current

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al d to assessing the validity of complaints about current advertisements that are claimed as not meeting the requirements.

Historic

al advertisements that are claimed as not meeting the requirements.

TGA does not charge for lodging a complaint with the Complaints Resolution Panel. To do so

Historic

al TGA does not charge for lodging a complaint with the Complaints Resolution Panel. To do so would be contrary to the intent of allowing

Historic

al would be contrary to the intent of allowing examined. The costs of validating complaints are recovered from sponsors of medical devices via

Historic

al examined. The costs of validating complaints are recovered from sponsors of medical devices via annual charges which are linked to the maintenance of the sponsor’s ARTG entry, spreading the

Historic

al annual charges which are linked to the maintenance of the sponsor’s ARTG entry, spreading the cost of the function evenly across all products.

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al cost of the function evenly across all products.

Good manufacturing practices

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al

Good manufacturing practices In Australia, manufacturers of therapeutic goods are required to hold a licence, except for

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al

In Australia, manufacturers of therapeutic goods are required to hold a licence, except for manufacturers of certain medical devices who have European conformity certification (CE

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al

manufacturers of certain medical devices who have European conformity certification (CE Mark). T

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al

Mark). To obtain the licence, a manufacturer must demonstrate that they have the ability to

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al

o obtain the licence, a manufacturer must demonstrate that they have the ability to comply with manufacturing principles, which include relevant Codes of GMP and Quality Hist

orical

comply with manufacturing principles, which include relevant Codes of GMP and Quality Systems, and have appropriate facilities to manufacture safely. Overseas manufacturersHist

orical

Systems, and have appropriate facilities to manufacture safely. Overseas manufacturerstherapeutic goods supplied to Australia must provide evidence of compliance with equivalent Hist

orical

therapeutic goods supplied to Australia must provide evidence of compliance with equivalent GMP standards or otherwise undergo onHist

orical

GMP standards or otherwise undergo on

documen

t

Advertisements for medical devices do not have to be approved prior to publication or

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t

Advertisements for medical devices do not have to be approved prior to publication or owever, advertisements must comply with the conditions of inclusion on the ARTG docu

ment

owever, advertisements must comply with the conditions of inclusion on the ARTG detailed in section 41FN(5) of the Act, Division 3 and 4, Part 2 of the Regulations and the TGAC.docu

ment

detailed in section 41FN(5) of the Act, Division 3 and 4, Part 2 of the Regulations and the TGAC.

The Complaints Resolution Panel considers complaints about advertisements for medical documen

t

The Complaints Resolution Panel considers complaints about advertisements for medical devices and other therapeutic goods appearing in broadcast and mainstream print media, docu

ment

devices and other therapeutic goods appearing in broadcast and mainstream print media,



of 35

The GMP related regulatory activities undertaken are as follows:

Licensing TGA usually undertakes on-site inspections of Australian manufacturers prior to the issue of a licence to ensure that the manufacturer can comply with the manufacturing principles set under the Act and has suitable premises to undertake the proposed manufacturing steps. The extent of the inspection depends on the size and complexity of the manufacturing processes.

The TGA participates in international harmonisation activities to ensure that GMP requirements applied in Australia are best practice.

Monitoring compliance The TGA undertakes periodic planned and unplanned inspections of manufacturers to assess the level of compliance with the applicable manufacturing standards, both domestically and overseas. The level and frequency of inspections for a particular manufacturer is influenced by its size and complexity but also by its compliance history. In particular, manufacturers with a history of lower levels of compliance are subject to a higher frequency of on-site inspections, compared with more compliant manufacturers, to ensure that therapeutic goods supplied in Australia are of appropriate quality and to allow TGA to take appropriate regulatory action where safety concerns are identified.

Investigation and enforcementThe TGA undertakes appropriate actions to promote and ensure compliance with the applicable GMP standards by manufacturers. Where a licensed Australian manufacturer poses unacceptable safety or quality risks, sanctions available range from (but are not limited to) revocation or suspension of the manufacturing licence to restriction of the type, kind or quantity of goods that can be manufactured for the Australian market at that site. Where required, sanctions are decided on a case-by-case basis after consideration of the circumstances involved and the best interests of the Australian consumer. Where the manufacturer is based outside of Australia, limits are placed on the ability of sponsors to make the products available on the Australian market.

Information and education The TGA promotes compliance with the manufacturing standards by producing guidelines and other informational materials primarily targeted at manufacturers whose products are supplied in Australia. These resources are made available through the TGA website. In addition, the TGA conducts seminars and information briefings to raise awareness of regulatory requirements, particularly when changes are proposed.

TGA contributes strongly to international programs to improve and harmonise manufacturing practices in developing regions through international meetings, seminars and training events.

Policy development and services to government The TGA provides services to Government in relation to the regulation of manufacturers, including specific technical and policy advice that is considered to be integral to the regulation of manufacturers.

Broader policy advice provided by the Department of Health is not subject to fees and charges.

6. Blood, blood components and biologicals Blood, blood components and plasma derivatives are regulated under the Act. Plasma derivatives are prescription medicines subject to full regulation, including compliance with set

Historic

al of goods that can be manufactured for the Australian market at that site. Where required,

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al of goods that can be manufactured for the Australian market at that site. Where required,

case basis after consideration of the circumsta

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al case basis after consideration of the circumsta

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al and the best interests of the Australian consumer. Where the manufacturer is based outside

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al and the best interests of the Australian consumer. Where the manufacturer is based outside Australia, limits are placed on the ability of sponsors to make the products available on the

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al Australia, limits are placed on the ability of sponsors to make the products available on the

Information and education

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al Information and educationromotes compliance with the manufacturing standards by producing guidelines and

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al romotes compliance with the manufacturing standards by producing guidelines and

other informational materials primarily targeted at manufacturers whose products are supplied

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al other informational materials primarily targeted at manufacturers whose products are supplied in Australia. These resources are made available through the TGA website. In addition, the TGA

Historic

al in Australia. These resources are made available through the TGA website. In addition, the TGA conducts seminars and information briefings to raise awareness of regulatory requirements,

Historic

al conducts seminars and information briefings to raise awareness of regulatory requirements, particularly when changes are proposed.

Historic

al particularly when changes are proposed.

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al

TGA contributes strongly to international programs to improve and harmonise manufacturing

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al

TGA contributes strongly to international programs to improve and harmonise manufacturing practices in developin

Historic

al

practices in developin

Policy development and services to government

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al

Policy development and services to governmentThe TGA provides services to Government in relation to the regulation of manufacturers, Hist

orical

The TGA provides services to Government in relation to the regulation of manufacturers, including specific technical and policy advice thaHist

orical

including specific technical and policy advice thamanufacturers.Hist

orical

manufacturers.

documen

tThe TGA participates in international harmonisation activities to ensure that GMP requirements

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tThe TGA participates in international harmonisation activities to ensure that GMP requirements

The TGA undertakes periodic planned and unplanned inspections of manufacturers to assess the

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tThe TGA undertakes periodic planned and unplanned inspections of manufacturers to assess the level of compliance with the applicable manufacturing standards, both domestically and

documen

tlevel of compliance with the applicable manufacturing standards, both domestically and overseas. The level and frequency of inspections for a particular manufacturer is influenced by

documen

toverseas. The level and frequency of inspections for a particular manufacturer is influenced by its size and complexity but also by its compliance history. In particular, manufacturers with a

documen

tits size and complexity but also by its compliance history. In particular, manufacturers with a history of lower levels of compliance are subject to a higher frequency of on

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thistory of lower levels of compliance are subject to a higher frequency of on-

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t-site inspections,

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tsite inspections,

compared with more compliant manufacturers, to ensure that therapeutic goods supplied in

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tcompared with more compliant manufacturers, to ensure that therapeutic goods supplied in Australia are of appropriate quality and to allow TGA to take appropriate regulatory action

documen

tAustralia are of appropriate quality and to allow TGA to take appropriate regulatory action

The TGA undertakes appropriate actions to promote and ensure compliance with the applicable

documen

t

The TGA undertakes appropriate actions to promote and ensure compliance with the applicable GMP standards by manufacturers. Where a licensed Australian manufacturer poses

documen

t

GMP standards by manufacturers. Where a licensed Australian manufacturer poses unacceptable safety or quality risks, sanctions available range from (but are not limited to) docu

ment

unacceptable safety or quality risks, sanctions available range from (but are not limited to) revocation or suspension of the manufacturing licence to restriction of the type, kind or quantity docu

ment

revocation or suspension of the manufacturing licence to restriction of the type, kind or quantity of goods that can be manufactured for the Australian market at that site. Where required, docu

ment

of goods that can be manufactured for the Australian market at that site. Where required, case basis after consideration of the circumstadocu

ment

case basis after consideration of the circumsta



of 35

standards, licensing of manufacture and inclusion in the ARTG after review of manufacturing, pre-clinical and clinical data. Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' do not include products derived through fractionation of plasma.

Some blood and blood components are exempt from regulation by TGA, including those:

• collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis or testing for a medical condition;

• manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care; and

• manufactured by a blood collection centre for a medical practitioner for therapeutic application to a particular patient under the practitioner's care.

Manufacturers of blood components are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013) and to submit a technical master file which demonstrates compliance to relevant standards.

Biologicals include human tissue and cell therapy products. Tissue therapy products involve the use of tissues as therapeutic goods, while cell therapy products involve the use of isolated living cells either as therapeutic goods or as replacements for cells that are defective or deficient in particular disorders.

Some examples of tissue therapies currently being used are:

• skin replacement after severe burns;

• transplantation of heart, kidney, liver, lung or pancreas;

• bone, tendons and ligaments to repair injuries;

• heart valves to replace defective heart valves; and

• corneas to restore eyesight.

Some examples of cell therapies currently being used, or currently under development are:

• chondrocytes used for cartilage regeneration;

• isolated pancreatic islet cells for the treatment of diabetes; and

• mesenchymal progenitor cells for the treatment of musculoskeletal defects and in a range of other clinical applications such as cardiovascular repair.

Inclusion on the ARTG The regulatory activities for biologicals involve the following registration and approval activities:

• management of applications for inclusion in the ARTG;

• sponsors of Class 1 biologicals are required to attest compliance with relevant mandatory standards;

• Class 2, 3 and 4 biologicals undergo pre-market evaluation prior to ARTG inclusion;

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al ransplantation of heart, kidney, liver, lung or pancreas

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al ransplantation of heart, kidney, liver, lung or pancreas

one, tendons and ligaments to repair injuries

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al one, tendons and ligaments to repair injuries

eart valves to replace defective heart valve

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al eart valves to replace defective heart valve

orneas to restore eyesight

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al orneas to restore eyesight

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al .

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al .

Some examples of cell therapies currently being used, or currently under development are:

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al Some examples of cell therapies currently being used, or currently under development are:

hondrocytes used for cartilage regeneration

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al hondrocytes used for cartilage regeneration

solated pancreatic islet cells for the treatment of diabetes

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al solated pancreatic islet cells for the treatment of diabetes

m

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al

mesenchymal progenitor cells for the treatment of musculoskeletal defects and i

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al

esenchymal progenitor cells for the treatment of musculoskeletal defects and iother clinical applications such as cardiovascular repair

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al

other clinical applications such as cardiovascular repair

Inclusion on the ARTG

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al

Inclusion on the ARTGThe regulatory activities for biologicals involve the following registration and approval Hist

orical

The regulatory activities for biologicals involve the following registration and approval activities:Hist

orical

activities:

•Historic

al

•

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tcollected by a medical practitioner in the course of medical treatment and for the purposes

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tcollected by a medical practitioner in the course of medical treatment and for the purposes

manufactured by a medical practitioner for therapeutic application to a particular patient

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tmanufactured by a medical practitioner for therapeutic application to a particular patient

manufactured by a blood collection centre for a medical practitioner for therapeutic

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tmanufactured by a blood collection centre for a medical practitioner for therapeutic

Manufacturers of blood components are required to demonstrate compliance with

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tManufacturers of blood components are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human

documen

tmanufacturing principles equivalent to the Australian Code of Good Manufacturing for human

issues and human cellular therapy products (2013) and to

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tissues and human cellular therapy products (2013) and to

submit a technical master file which demonstrates compliance to relevant standards.

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tsubmit a technical master file which demonstrates compliance to relevant standards.

Biologicals include human tissue and cell therapy products. Tissue therapy products involve the

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tBiologicals include human tissue and cell therapy products. Tissue therapy products involve the

herapeutic goods, while cell therapy products involve the use of isolated living

documen

t

herapeutic goods, while cell therapy products involve the use of isolated living cells either as therapeutic goods or as replacements for cells that are defective or deficient in

documen

t

cells either as therapeutic goods or as replacements for cells that are defective or deficient in

Some examples of tissue therapies currently being used documen

t

Some examples of tissue therapies currently being used are:documen

t

are:

ransplantation of heart, kidney, liver, lung or pancreasdocumen

t

ransplantation of heart, kidney, liver, lung or pancreas



of 35

• highly manipulated Class 3 and 4 biologicals are subject to the highest levels of pre-market evaluation; and

• manufacturers of Class 2, 3 and 4 biologicals are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013).

Compliance monitoring and enforcement • Post-market controls include ongoing manufacturing inspections, managing adverse event

reporting, investigations and recalls.

• The TGA also provides information and support to the regulated industry and consumers and is responsible for the maintenance of the regulatory framework.


Costs of TGA activitiesIn line with the Australian Government Charging Framework total costs are categorised into the following groups for cost allocation.

Direct costs: can be easily traced to a cost object with a high degree of accuracy. The allocation of direct costs to a cost object is relatively straightforward. The most common direct costs are staff salaries (including oncosts, such as training, superannuation and leave) and supplier costs (e.g. office supplies).

Indirect costs: are the costs that cannot be easily linked to a cost object or for which the costs of tracking this outweigh the benefits. Indirect costs are apportioned to a cost object using the internal costing methodology. Common indirect costs include overhead costs such as salaries of staff in corporate (e.g. finance, human resources, IT) areas, or accommodation costs (e.g. rent, maintenance, utilities).

In 2015, a software solution was installed to improve TGA’s activity based costing (ABC) capability. The first staff work effort survey was conducted in 2015 to attribute the time of regulatory staff to regulatory activities. Due to a significant restructure of TGA on 1 July 2015, the work effort survey is being undertaken again.

Fees and chargesThe characteristics of a government activity determine the type of cost recovery charge used. There are two types of cost recovery charges:

Cost recovery fees: fees charged when a good, service or regulation (in certain circumstances) is provided directly to a specific individual or organisation.

Fees are used to recover the cost of the pre-market services performed. Fees are designed to reflect as closely as possible the underlying cost of service. TGA has limited authority under the Act to waive or reduce fees.

Cost recovery levies: charges imposed when a good, service or regulation is provided to a group of individuals or organisations (e.g. an industry sector) rather than to a specific individual or organisation. A cost recovery levy is a tax and is imposed via a separate taxation Act. It differs from general taxation as it is ‘earmarked’ to fund activities provided to the group that pays the levy.

Historic

al are the costs that cannot be easily linked to a cost object or for which the costs of

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al are the costs that cannot be easily linked to a cost object or for which the costs of

tracking this outweigh the benefits. Indirect costs are apportioned to a cost object using the

Historic

al tracking this outweigh the benefits. Indirect costs are apportioned to a cost object using the internal costing methodology. Common indirect costs include overhead costs such as salaries of

Historic

al internal costing methodology. Common indirect costs include overhead costs such as salaries of staff in corporate (e.g. finance, human resources, IT) areas, or accommodation costs (e.g. rent,

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al staff in corporate (e.g. finance, human resources, IT) areas, or accommodation costs (e.g. rent,

solution

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al solution was installed

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al was installedstaff work

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al staff work effort survey

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al effort survey

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al staff to

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al staff to regulatory

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al regulatory act

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al activities

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al ivities

the work effort survey is being undertaken again.

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al the work effort survey is being undertaken again.

Fees and charges

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al Fees and chargesThe characteristics of a government activity determine the

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al

The characteristics of a government activity determine the There are two types of cost recovery charges:

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al

There are two types of cost recovery charges:

Cost recovery fees:

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al

Cost recovery fees:is provided directly to a specific individual or organisation

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al

is provided directly to a specific individual or organisation

Fees are used to recover the cost ofHistoric

al

Fees are used to recover the cost ofreflect as closely as possible the underlying cost of service. TGA has Hist

orical

reflect as closely as possible the underlying cost of service. TGA has Act to waiveHist

orical

Act to waive

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tmarket controls include ongoing manufacturing inspections, managing adverse event

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tmarket controls include ongoing manufacturing inspections, managing adverse event

The TGA also provides information and support to the regulated industry and consumers

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tThe TGA also provides information and support to the regulated industry and consumers

ing Framework

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ting Framework total costs are categorised into the

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ttotal costs are categorised into the

can be easily traced to a cost object with a high degree of accuracy. The allocation

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t

can be easily traced to a cost object with a high degree of accuracy. The allocation tively straightforward

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tively straightforward. The most common direct costs are

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. The most common direct costs are ing oncosts, such as training, superannuation and leave) and supplier costs docu

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ing oncosts, such as training, superannuation and leave) and supplier costs

are the costs that cannot be easily linked to a cost object or for which the costs of documen

t

are the costs that cannot be easily linked to a cost object or for which the costs of tracking this outweigh the benefits. Indirect costs are apportioned to a cost object using the docu

ment

tracking this outweigh the benefits. Indirect costs are apportioned to a cost object using the




of 35

All therapeutic products registered, listed or included on the ARTG are subject to annual charges except for export only products and IVD medical devices. Annual charges are used to recover the costs of pharmacovigilance and other post market monitoring and compliance activities where:

• they cannot reasonably be assigned to individual sponsors;

• they maintain the integrity of the regulated industry to the benefit of all sponsors; and

• assigning costs to individual sponsors would deter sponsors from disclosing important public health information, such as reporting adverse events.

Different levels of pharmacovigilance are required for different classes of therapeutic goods depending on the level of risk the good could pose. Annual charges have been set to reflect the level of pharmacovigilance and post-market work required for the regulated good rather than the size of the individual business. For example, the annual charge for a class 1 medical device (other than a class 1 medical device that has a measuring function or is supplied in a sterile state) is $80 whereas for a high risk prescription medicine (biologic) the annual charge is $6,725.

2016-17 fees and charges TGA fees and charges are reviewed annually to ensure full cost recovery. An increase of 2.25 per cent was applied for 2016-17 to meet estimated cost increases mainly in employee expenses as a result of a 2 per cent salary increase in the Department of Health Enterprise Agreement.

A well-established formula has been used in most years, based on the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent) (both for the year to September). This year the formula resulted in 2.25 per cent. The Office of Best Practice Regulation has advised that a Regulatory Impact Statement was not required for this change.

The amendment regulations were approved by the Executive Council at their meeting of 5 May 2016. As a result all TGA fees and charges will increase by 2.25 per cent from 1 July 2016, subject to rounding. In addition, a small number of other, minor, changes relating to fees for biologicals were also approved. These changes are:

• to clarify that the fees applying under the Regulations for requests by sponsors to vary an entry in the Register for a biological do not apply where the variation would result in the creation of a separate and distinct biological (a new application for marketing approval must be made in such a case);

• to allow sponsors of Class 3 and 4 biologicals to pay a lower fee ($1,050 from 1 July 2016 rather than that fee and an evaluation fee of $16,800) for a request to vary an entry in the Register if the request does not involve the evaluation of quality and manufacturing information (this higher fee has not been charged to date); and

• to set separate evaluation fees for ‘safety-related’ variations to an entry in the ARTG for Class 3 or 4 biologicals (these are changes resulting only in reducing the class of persons for whom the biological is suitable, or in adding a warning or precaution not involving a comparison with any other goods in relation to quality, safety or efficacy), and setting different fees depending on whether the request involves evaluation by the TGA.

A link to the fees and charges applicable from 1 July 2016 is provided in Appendix 2. Historic

al The amendment regulations were approved

Historic

al The amendment regulations were approved

all TGA fees and charges will

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al all TGA fees and charges will

subject to rounding. In addition, a small number of other, minor, changes relating to fees for

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al subject to rounding. In addition, a small number of other, minor, changes relating to fees for biologicals were also approved. These changes are:

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al biologicals were also approved. These changes are:

s applying under the Regulations

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al s applying under the Regulationsentry in the Register for a biological do not apply where the variation would result in the

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al entry in the Register for a biological do not apply where the variation would result in the creation of a separate and distinct biological (a new application for marketing approval must

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al creation of a separate and distinct biological (a new application for marketing approval must be made in such a case);

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al be made in such a case);

allow sponsors

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al allow sponsors of Class 3 and 4 biologicals to pay a lower fee ($1,050 from 1 July 2016

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al of Class 3 and 4 biologicals to pay a lower fee ($1,050 from 1 July 2016

rather than that fee and an evaluation fee of $16,800) for a request to vary an entry in the

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al rather than that fee and an evaluation fee of $16,800) for a request to vary an entry in the

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al Register if the request does not involve the evaluation

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al Register if the request does not involve the evaluation infor

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al

information (this higher fee has not been charged

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al

mation (this higher fee has not been charged

•

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al

• t

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al

to

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al

o set separate evaluation fees for ‘safety

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al

set separate evaluation fees for ‘safety3 or 4 biologicals (these are changes resulting only in reducing the class of persons for whom

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al

3 or 4 biologicals (these are changes resulting only in reducing the class of persons for whom the

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al

the biological is suitable, or in adding a warning or precaution not involving a comparison

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al

biological is suitable, or in adding a warning or precaution not involving a comparison with any other goods in relation to quality, safety or efficacy), and setting different fees Hist

orical

with any other goods in relation to quality, safety or efficacy), and setting different fees depending on whether the request involves evaluation by the TGA.Hist

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depending on whether the request involves evaluation by the TGA.

A link to Historic

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A link to

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tDifferent levels of pharmacovigilance are required for different classes of therapeutic goods

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tDifferent levels of pharmacovigilance are required for different classes of therapeutic goods depending on the level of risk the good could pose. Annual charges have been set to reflect the

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tdepending on the level of risk the good could pose. Annual charges have been set to reflect the market work required for the regulated good rather than

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tmarket work required for the regulated good rather than

the size of the individual business. For example, the annual charge for a class 1 me

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tthe size of the individual business. For example, the annual charge for a class 1 medica

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tdical device

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tl device

medical device that has a measuring function or is supplied in a sterile

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tmedical device that has a measuring function or is supplied in a sterile

state) is $80 whereas for a high risk prescription medicine (biologic) the annual charge is

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tstate) is $80 whereas for a high risk prescription medicine (biologic) the annual charge is

TGA fees and charges are reviewed annually to ensure full cost recovery. An increase of 2.25

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tTGA fees and charges are reviewed annually to ensure full cost recovery. An increase of 2.25

increases

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tincreases mainly in employee expenses as a

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Department of Health Enterprise Agreement

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has been used in most years, based on the Australian Bureau of

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has been used in most years, based on the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent) (both for the

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by the Executive Council at their meeting of incredocu

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incre



of 35

Financial and non-financial performance

a) Financial performance 2014–15

Actual $’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue3

Revenue from Government

6.995 2.227 1.800 1.800 1.800

Sale of goods and services 130.764 133.908 138.384 142.035 147.568

Other revenue and gains 1.027 0.249 0.200 0.200 0.200

Total A 138.786 136.385 140.384 144.035 149.568

B: Expenses4

Employee expenses 83.552 79.108 94.308 96.284 98.236

Suppliers 42.071 44.587 45.498 43.165 41.405

Depreciation and amortisation

5.620 4.368 8.190 8.190 9.927

Write-down and impairment of assets

2.205 0.510

Other expenses and losses

0.001 0.001

Total B 133.448 128.574 147.996 147.639 149.568

Surplus (deficit) 5.338 7.811 (7.612) (3.604) 0.000

TGA's activities are primarily cost recovered from industry. However, the TGA received appropriation funding in 2014-5 for aligning Australia's and New Zealand's regulation of therapeutic goods. In addition, the TGA continues to receive appropriation funding in the form of an interest equivalency payment for funds held in the TGA special account (reserves).

While our financial performance is within the target budget range when compared to budget, the surplus in 2014–15 was largely the result of lower than expected employee expenses due to lower staffing levels and stable employee remuneration over recent financial years.

3 Excludes Office of Drug Control 4 Excludes Office of Drug Control

Historic

al 5.620

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al 5.620

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al

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Surplus (deficit)

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al

Surplus (deficit)

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al

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TGA's activities are primarily cost recovered from industry. However, the TGA receiv

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al

TGA's activities are primarily cost recovered from industry. However, the TGA receivappropriation funding in 2014

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al

appropriation funding in 2014therapeutic goods. In addition, the TGA continuesHist

orical

therapeutic goods. In addition, the TGA continuesan Hist

orical

an interest equivalency payment for funds held in the TGA specialHistoric

al

interest equivalency payment for funds held in the TGA special

While our financial performance is within the target budget range when compared to budget, the Historic

al

While our financial performance is within the target budget range when compared to budget, the

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of 35

Detailed financial performance information is discussed with industry representative bodies at bilateral meetings held each year.

The TGA aims to maintain reserves to provide a buffer for volatility in revenue streams (the number and type of evaluation applications) and respond to major external or unplanned impacts (recalls, product tampering). Depreciation is also accumulated for the replacement of assets. The Government expects the TGA to manage within its cost recovery resources and therefore investment, such as the Business Improvement Program, must also come from the responsible management of these reserves. The target for the reserve balance is set to be at least one quarter of operating expenses. During 2015-16 our reserves will remain above that target but then reduce in 2016-17 as a result of the costs of implementing the 2016-17 Budget measure “improving the Regulation of Therapeutic Goods in Australia” which involves expenditure of $20.4 million from TGA reserves over four years.

Financial performance by industry sector group is included in Appendix 1.

b) Non- financial performanceThe TGA reports to stakeholders at six monthly intervals on performance against a set of agreed KPIs. The KPIs have been endorsed by the Australian Therapeutic Goods Advisory Council following consultation with the TGA-Industry Consultative Committee. For more information on the TGA’s KPIs please visit: TGA key performance indicators.

The KPIs are high-level indicators of performance against our strategic intent. Within that matrix of KPIs is a requirement for measuring whether 'business operations are consistent and meet agreed service and timeliness standards'. Measures of specific business activities will continue to be documented in our half-yearly performance reports.

These reports are provided to members of the TGA-Industry Consultative Committee to enable us to report on specific parameters of relevance to industry stakeholders and to enable stakeholders to provide performance feedback. They provide detailed quantitative information about our performance on the timeliness of business activities as well as information for industry about the volumes of work performed. Key highlights for 2014-15 were:

• The TGA worked closely with industry on new initiatives to help improve the efficiency of a number of application and administrative processes. This included implementing a new business services portal to provide industry with self-service technology to conduct simple regulatory transactions with the TGA.

• For medicines, the pilot to introduce the electronic Common Technical Document (eCTD) format for over-the-counter and prescription medicines was completed, eliminating the need for paper applications. Other initiatives included releasing an electronic smart form for sponsors to notify the TGA of prescription medicines shortages, reducing the reliance on phone, email and letter communication.

• Medical devices initiatives included implementation of regulatory changes to allow Australian medical device manufactures to obtain market approval for most products using European notified bodies’ conformity assessment.

• The TGA substantially met all performance targets in relation to completing applications for registration of therapeutic goods within the legislated timeframes. Hist

orical

These reports are provided to members of the TGA

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al These reports are provided to members of the TGAus to report on specific parameters of relevance to industry stakeholders and to enable

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al us to report on specific parameters of relevance to industry stakeholders and to enable stakeholders to provide performance feedback. They provide detailed quantitative information

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al stakeholders to provide performance feedback. They provide detailed quantitative information about our performance on the timeliness of busines

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al about our performance on the timeliness of businesindustry about the volumes of work performed

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al industry about the volumes of work performed. Key highlights for 2014

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al . Key highlights for 2014

he TGA worked closely with industry on new initiatives to help improve the efficiency of a

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al he TGA worked closely with industry on new initiatives to help improve the efficiency of a number of application and administrative processes. This included implementing a new

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al number of application and administrative processes. This included implementing a new business services portal to provide industry with self

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al business services portal to provide industry with self

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al tory transactions with the TGA

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al tory transactions with the TGA

or medicines, the pilot to introduce the electronic Common Technical Document (eCTD)

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al or medicines, the pilot to introduce the electronic Common Technical Document (eCTD)

format for over

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need for paper applications. Other initiatives included releasing an electronic smart form for

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al need for paper applications. Other initiatives included releasing an electronic smart form for sponsors to notify the TGA of prescription medicines shortages, reducing the reliance on

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al

sponsors to notify the TGA of prescription medicines shortages, reducing the reliance on phone,

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al

phone, email and letter communication

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al

email and letter communication

•

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al

• M

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al

Medical devices initiatives included implementation of regulatory changes to

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al

edical devices initiatives included implementation of regulatory changes to Australian medical device

Historic

al

Australian medical deviceEuropean notified bodies’ confoHist

orical

European notified bodies’ confo

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al

• THistoric

al

T

documen

tresponsible management of these reserves. The target for the reserve balance is set to be at least

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tresponsible management of these reserves. The target for the reserve balance is set to be at least remain above that target

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tremain above that target17 Budget measure

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t17 Budget measure “improving the Regulation of Therapeutic Goods in Australia” which involves expenditure of

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t“improving the Regulation of Therapeutic Goods in Australia” which involves expenditure of

performance

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tperformance against a set

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tagainst a set

. The KPIs have been endorsed by the Australian Therapeutic Goods Advisory Council

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t. The KPIs have been endorsed by the Australian Therapeutic Goods Advisory Council

Industry Consultative Committee. For more information on

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tIndustry Consultative Committee. For more information on

TGA key performance indicators

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t

TGA key performance indicators.

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t

.

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t

level indicators of performance against our

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t

level indicators of performance against our strategic intent. Within that

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strategic intent. Within that matrix of KPIs is a requirement for measuring whether 'business

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matrix of KPIs is a requirement for measuring whether 'business operations are consistent and

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t

operations are consistent and meet agreed service and timeliness standards'. Measures of specific business activities will

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meet agreed service and timeliness standards'. Measures of specific business activities will yearly performance reports.docu

ment

yearly performance reports.

These reports are provided to members of the TGA documen

t

These reports are provided to members of the TGA-documen

t

-Industry Consultative Committee to enable documen

t

Industry Consultative Committee to enable us to report on specific parameters of relevance to industry stakeholders and to enable docu

ment

us to report on specific parameters of relevance to industry stakeholders and to enable stakeholders to provide performance feedback. They provide detailed quantitative information docu

ment

stakeholders to provide performance feedback. They provide detailed quantitative information

https://www.tga.gov.au/publication/tga-key-performance-indicators-our-indicators-and-reporting-measures



of 35

Fees and charges and other reforms

a) Annual charges exemption schemeThe annual charges exemption (ACE) scheme replaced the low value turnover (LVT) scheme on 1 July 2015 following a review of the operation of the LVT which included a public consultation and Regulatory Impact Statement.

The ACE scheme is more equitable, reduces red tape for business and provides administrative efficiencies for the TGA. It recognises that TGA's post-market monitoring costs are incurred for products that have been placed into the market and allows sponsors to enter their products in the ARTG in advance of their marketing with no annual charge (until turnover commences). For more information on the ACE please visit: Annual charge exemption scheme.

When the ACE scheme was introduced the TGA undertook to monitor the impact of the new scheme on the therapeutic goods industry. In December 2015 a preliminary assessment of the financial impact of the ACE scheme on industry sponsors across a range of business areas showed, at that point in time, a forecast increase of $2.5 million or 5 per cent in annual charges in 2015-16 under the ACE scheme. The preliminary assessment report is available on the TGA website.

At the time of undertaking the preliminary assessment the ACE scheme had been in operation for only a few months (July 2015 to October 2015), and the full impact and effectiveness of the ACE scheme will not be known until it has been in operation for a minimum of 2 years. The impact of the introduction of the ACE scheme will continue to be monitored as the scheme matures and changes will be made, as required, to ensure appropriate cost recovery for each sector.

b) Review of medicines and medical devices regulationAn independent review of medicines and medical devices regulation was announced on 24 October 2014. The aim of the review was to examine the TGA’s regulatory framework and processes with a view to identifying:

• areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and

• opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

In its two staged report (stage 1 released on 31 March 2015 and stage 2 released on 31 July 2015), the review panel provided the Government with 58 recommendations. In summary, the report recommended:

• expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances;

• identifying comparable overseas regulators using transparent criteria;

• enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements for products in the ARTG;

• improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products;

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al Review of medicines

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al Review of medicines and medical devices regulation

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al and medical devices regulation

endent review of medicines and m

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al endent review of medicines and me

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al edical devices regulation was announced on

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al dical devices regulation was announced on October 2014. The aim of the review was to examine the TGA’s regulatory framework and

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al October 2014. The aim of the review was to examine the TGA’s regulatory framework and identifying:

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al identifying:

reas of unnecessary, duplicative, or ineffective regulation that could be removed or

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al reas of unnecessary, duplicative, or ineffective regulation that could be removed or

streamlined without undermining the safety or quality of therapeutic goods available in

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al streamlined without undermining the safety or quality of therapeutic goods available in

Historic

al Australia; and

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al Australia; and

pportunities to enhance the regulatory framework so

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al pportunities to enhance the regulatory framework so

positioned to respond effectively to global trends in the development, manufacture,

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al positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

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al marketing and regulation of therapeutic goods.

In its tw

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al

In its two staged report (stage 1 released on 3

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al

o staged report (stage 1 released on 331

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al

31 J

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al

July

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uly 201

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2015

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5), the review

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), the review summary, the report recommended:

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summary, the report recommended:

•Historic

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• expanding the pathways by which sponsors can seek marketing approval for a medicine or Historic

al

expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisatiHist

orical

medical device, including making provision for utilisati

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tThe ACE scheme is more equitable, reduces red tape for business and provides administrative

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tThe ACE scheme is more equitable, reduces red tape for business and provides administrative market monitoring costs are incurred for

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tmarket monitoring costs are incurred for products that have been placed into the market and allows sponsors to enter their products in

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tproducts that have been placed into the market and allows sponsors to enter their products in nce of their marketing with no annual charge (until turnover commences). For

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tnce of their marketing with no annual charge (until turnover commences). For

the TGA undertook to monitor the impact of the new

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tthe TGA undertook to monitor the impact of the new

a preliminary assessment of the

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ta preliminary assessment of the

a range of business areas

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ta range of business areas

time, a forecast increase of $2.5 million or 5 per cent

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ttime, a forecast increase of $2.5 million or 5 per cent in annual charges

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tin annual charges

assessment report

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tassessment report is available on the TGA

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tis available on the TGA

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the ACE scheme had been in operation

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impact of the introduction of the ACE scheme will continue to be monitored as the scheme , as required, to ensure appropriate cost recovery for each docu

ment

, as required, to ensure appropriate cost recovery for each

and medical devices regulationdocumen

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and medical devices regulation

https://www.tga.gov.au/annual-charge-exemption-scheme

https://www.tga.gov.au/interim-impact-assessment-therapeutic-goods-administration-annual-charge-exemption-ace-scheme



of 35

• expanding the pathways by which sponsors can approve an ingredient for use in a listed medicine, and for marketing approval of a listed complementary medicine;

• enhancing the transparency and predictability of processes and evidence requirements associated with ingredient approvals and complementary medicine marketing approvals;

• improving and clarifying the interface and synergies between the market approval of therapeutic goods and advertising requirements that ensure consumer protections are balanced with the availability of information for consumers and health professionals to make informed spending and health decisions; and

• enhancing and streamlining the advertising framework to facilitate and maximise compliance and the management of complaints.

In 2016-17 the TGA will manage a comprehensive reform agenda based on the 2016-17 Budget measure “improving the Regulation of Therapeutic goods in Australia”.

Risk assessmentA cost recovery risk assessment for the proposed reform program was undertaken in May 2015 resulting in a medium risk rating.

The cost recovery risk rating of medium is based on assessment of the criteria using the Charging Risk Assessment (CRA) template. The key medium to high risks for cost recovery are that the amount to cost recover exceeds $20 million (although implementation is to be funded from reserves), the source of recovery is through fees and levies, they involve an existing Act of Parliament (for TGA charges to be reviewed) and many stakeholders will be affected.

The most likely risks identified for any ongoing changes to cost recovery arrangements were:

• cost recovery fees creating a disincentive to products entering the market;

• inherent risks in implementing diverse cost recovery arrangements; and

• potential for misunderstanding of how fees and charges are calculated.

These risks are to be addressed by:

• continued improvements in regulatory and administrative functions;

• implementing best practice in activity based costing (ABC) methodology;

• working closely with stakeholders and industry representatives to mitigate the cost impact to business; and

• ensuring charging practices are aligned to our services and are transparent and defensible.

From a regulatory perspective risk management is applied to regulating therapeutic goods by:

• identifying, assessing, and evaluating the risks posed by therapeutic goods before they can be approved for use in Australia (pre-market assessment or evaluation);

• identifying, assessing, and evaluating the risks posed by manufacturing processes before a manufacturer is issued with a licence to manufacture therapeutic goods (licensing of manufacturers); and

• identifying, assessing, and evaluating the risks that may arise following approval of the product and licensing of the manufacturer (post-market surveillance).

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al for any ongoing changes to cost recovery arrangements

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al for any ongoing changes to cost recovery arrangements

ost recovery fees creating a disincentive to products entering the market

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al ost recovery fees creating a disincentive to products entering the market

nherent risks in implementing div

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al nherent risks in implementing diverse cost recovery arrangements;

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al erse cost recovery arrangements;

otential for misunderstanding of how fees and charges are cal

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al otential for misunderstanding of how fees and charges are cal

addressed by:

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al addressed by:

ontinued improvements in regulatory and administrative functions

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al ontinued improvements in regulatory and administrative functions

mplementing

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al mplementing best practice in activity

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orking closely with stakeholders and industry representatives to mitig

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to business;

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to business; and

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and

•

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ensuring charging practices are aligned to our services and are transparent and defensible.

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nsuring charging practices are aligned to our services and are transparent and defensible.


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million (although implementation is to be funded

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(although implementation is to be funded through fees and levies, they involve an

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(for TGA charges to be reviewed) and many stakeholders will be affected.

for any ongoing changes to cost recovery arrangements documen

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for any ongoing changes to cost recovery arrangements

ost recovery fees creating a disincentive to products entering the marketdocumen

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ost recovery fees creating a disincentive to products entering the market



of 35

Stakeholder engagementTGA consults with industry associations separately on regulatory matters and cost impacts relating to specific sectors. Industry associations are also consulted in the process of regulatory development and reform, and feedback is taken into account in developing regulatory impact statements, and in developing cost recovery arrangements. Meetings are held with key industry representative bodies each year to discuss financial forecasts and as a part of the consultation process on cost recovery. The TGA also reports to stakeholders against a set of agreed Key Performance Indicators (KPIs).

Consultation on the proposed fees and charges for 2016-17 was undertaken at bilateral meetings with the following industry representative groups in February and March 2016.

1. Medicines Australia

2. The Generic and Biosimilar Medicines Association

3. AusBiotech

4. Medical Technology Association of Australia

5. IVD Australia

6. Australian Dental Industry Association

7. The Australian Self-Medical Industry

8. Complementary Medicines Australia

9. Accord Australasia

Key forward events

Portfolio charging reviewThe Department of Health will undertake a portfolio charging review in the 2017–18 Budget context. The review will encompass TGA’s cost recovery activities, and include such things as: identifying any policy, legal and operational issues and risks related to existing cost recovery activities; evaluating the relevance of charging activities and consistency with the planned policy outcomes of the Australian Government; assessing the potential to charge for new or existing activities; and stating whether charging should continue for existing activities or be changed, and on what basis.

Key forward events schedule Next scheduled update

Actual financial and performance results for 2015-16

Reported in the Department of Health’s Annual Report

Scheduled portfolio charging review 2017–18

Forward (financial) estimates 30 June 2017 Hist

orical

Key forward events

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al Key forward events

Portfolio charging review

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al Portfolio charging reviewThe Department of Health will undertake a portfolio charging review in the 2017

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al The Department of Health will undertake a portfolio charging review in the 2017context. The review will

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al context. The review will encompass TGA’s

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al encompass TGA’s

any po

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al licy, legal and operational issues and risks related to existing cost recovery

evaluat

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al ing the relevance of charging activities and consistency with the planned policy

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al the relevance of charging activities and consistency with the planned policy

outcomes of the Australian

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al Government

; and

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and on what basis

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Key forward events schedule

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Key forward events schedule

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results for 2015Historic

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for 2015Historic

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tps in February and March 2016.



of 35

CRIS approval and change registerDate of CRIS change Approver CRIS change

01/07/2014 Secretary Department of Health CRISs for 1 July 2014

01/07/2014 Assistant Minister for Health CRISs for 1 July 2014

01/07/2015 Secretary Department of Health

(noted by Assistant Minister for Health)

Individual sector based CRISs updated for 1 July 2015, except for the over the counter medicines CRIS which was updated on 1 January 2016 to reflect fee changes on 1 January 2016

01/07/2016 Secretary Department of Health Consolidated CRIS updated for 1 July 2016

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al docu

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tIndividual sector based CRISs updated for 1 July 2015,

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tcounter medicines CRIS which

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twhich

was updated on 1 January

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twas updated on 1 January

to reflect fee changes on

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1 January 2016

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t1 January 2016

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1 July 2016

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of 35

Appendix 1 - Financial performance by industry sector group

1. Prescription medicinesVolumes5 2014–15

Actual 2015–16 Forecast

2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Biological prescription medicines

461 550 550 550 550

Non-biological prescription medicines – higher charge

N/A 475 475 475 475

Non-biological prescription medicines – lower charge

4,842 5,901 5,901 5,901 5,901

Revenue and expenses 2014–15 Actual

$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue

Cost recovery revenue 65.6 68.7 70.8 72.7 75.5

Total A 65.6 68.7 70.8 72.7 75.5

B: Expenses6

Direct 35.4 34.7 40.0 39.9 40.5

Indirect 22.8 22.3 25.8 25.7 26.0

Total B 58.1 57.0 65.8 65.6 66.5

Surplus (deficit) 7.4 11.7 5.0 7.0 9.0

5 Number of entries on the ARTG subject to annual charge. 6 Due to restructure in the corporate area, TGA is undertaking a review of its activity based costing model to reflect the new structure. The direct and indirect expenses are derived based on the ratio from the previous model.

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al

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al 65.6

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al 65.6 68.7

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al 68.7

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al

Historic

al

Historic

al

Historic

al

Historic

al 65

Historic

al 65.6

Historic

al .6

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al Indirect

Historic

al Indirect

Historic

al

Historic

al

Total B

Historic

al

Total B

Historic

al

Historic

al

Historic

al

Historic

al

Surplus (deficit)

Historic

al

Surplus (deficit)

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t

documen

t2018

documen

t2018–

documen

t–19

documen

t19

documen

tEstimate

documen

tEstimate

documen

t

documen

t

documen

t550

documen

t550

documen

t

documen

t

documen

t

documen

t475

documen

t475 475

documen

t475

documen

t

documen

t

documen

t

documen

t

documen

t5,901

documen

t5,901 5,901

documen

t5,901

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

2015

documen

t

2015–

documen

t

–16

documen

t

16

documen

t

Forecastdocumen

t

Forecastdocumen

t

$’mdocumen

t

$’mdocumen

t

documen

t

2016

documen

t

2016–

documen

t

–17

documen

t

17

documen

t

Budgetdocumen

t

Budgetdocumen

t

$’mdocumen

t

$’mdocumen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t



of 35

2. Over the counter medicinesVolumes7 2014–15


2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Over the counter medicines

2,064 2,451 2,451 2,451 2,451


$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue


Total A 7.7 8.0 8.2 8.4 8.8

B: Expenses8

Direct 5.1 5.0 5.7 5.7 5.8

Indirect 2.9 2.8 3.3 3.3 3.3

Total B 7.9 7.8 9.0 9.0 9.1

Surplus (deficit) (0.3) 0.2 (0.8) (0.5) (0.3)

7 Number of entries on the ARTG subject to annual charge. 8 Due to restructure in the corporate area, TGA is undertaking a review of its activity based costing model to reflect the new structure. The direct and indirect expenses are derived based on the ratio from previous model.

Historic

al

Historic

al 7.9

Historic

al 7.9 7.8

Historic

al 7.8

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al (0.3)

Historic

al (0.3)

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t

documen

t

documen

t

documen

t

documen

t18

documen

t18

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t2018

documen

t2018–

documen

t–19

documen

t19

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t8.2

documen

t8.2 8.4

documen

t8.4

documen

t

documen

t

documen

t

documen

t

8.2

documen

t

8.2

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

5.0documen

t

5.0documen

t

documen

t

documen

t

documen

t

2.8documen

t

2.8documen

t

documen

t

documen

t

documen

t



of 35

3. Complementary medicinesVolumes9 2014–15


2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Registered complementary medicines

131 127 127 127 127

Listed complementary medicines

8,262 9,491 9,491 9,491 9,491


$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue


Total A 11.4 12.6 13.0 13.3 13.8

B: Expenses10

Direct 13.7 13.4 15.5 15.4 15.6

Indirect 9.0 8.8 10.2 10.1 10.3

Total B 22.7 22.2 25.6 25.6 25.9

Surplus (deficit) (11.3) (9.6) (12.7) (12.3) (12.1)


Historic

al

Historic

al 13.7

Historic

al 13.7

Historic

al

Historic

al

Historic

al 9.0

Historic

al 9.0

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al 22.7

Historic

al 22.7

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al Surplus (deficit)

Historic


Historic

al

Historic

al (11.3)

Historic

al (11.3)

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t9,491

documen

t9,491

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t2017

documen

t2017–

documen

t–18

documen

t18

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t2018

documen

t2018

documen

tEstimate

documen

tEstimate

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

13.0

documen

t

13.0

documen

t

documen

t

documen

t

documen

t

documen

t

12.6

documen

t

12.6 13.0

documen

t

13.0

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t



of 35

4. Medical devices, including in-vitro diagnostic (IVD) devicesVolumes11 2014–15


2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Included medical devices 39,124 40,480 40,480 40,480 40,480

Other therapeutic goods 448 340 340 340 340


$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue


Total A 32.0 31.7 32.7 33.5 34.8

B: Expenses12

Direct 12.9 12.6 14.6 14.6 14.8

Indirect 11.2 11.0 12.7 12.6 12.8

Total B 24.1 23.6 27.3 27.2 27.6

Surplus (deficit) 7.9 8.1 5.4 6.3 7.3


Historic

al

Historic

al 12.9

Historic

al 12.9

Historic

al

Historic

al

Historic

al 11.2

Historic

al 11.2 11.0

Historic

al 11.0

Historic

al

Historic

al

Historic

al

Historic

al 24.1

Historic

al 24.1

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al 7.9

Historic

al 7.9

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t

documen

t

documen

t40,480

documen

t40,480

documen

t

documen

t

documen

t340

documen

t340

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t2017

documen

t2017–

documen

t–18

documen

t18

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t2018

documen

t2018

documen

tEstimate

documen

tEstimate

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

32.7

documen

t

32.7

documen

t

documen

t

documen

t

documen

t

documen

t

31.7

documen

t

31.7 32.7

documen

t

32.7

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

12.6documen

t

12.6documen

t



of 35

5. Good manufacturing practicesVolumes13 2014–15


2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Low level GMP licence 116 104 104 104 104

High level GMP licence 162 163 163 163 163


$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue


Total A 12.1 11.1 11.5 11.8 12.2

B: Expenses14

Direct 9.3 9.1 10.5 10.5 10.7

Indirect 3.6 3.5 4.0 4.0 4.1

Total B 12.9 12.6 14.6 14.5 14.7

Surplus (deficit) (0.7) (1.5) (3.1) (2.8) (2.5)


Historic

al

Historic

al 3.6

Historic

al 3.6

Historic

al

Historic

al

Historic

al

Historic

al 12.9

Historic

al 12.9

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al (0.7)

Historic

al (0.7)

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t163

documen

t163

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t2017

documen

t2017–

documen

t–18

documen

t18

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t2018

documen

t2018–

documen

t–19

documen

t19

documen

tEstimate

documen

tEstimate

documen

t$’m

documen

t$’m

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t11.5

documen

t11.5 11.8

documen

t11.8

documen

t

documen

t

documen

t

documen

t

documen

t

11.5

documen

t

11.5

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

9.1documen

t

9.1documen

t

documen

t

documen

t

documen

t

documen

t

documen

t



of 35

6. Blood, blood components and biologicalsVolumes15 2014–15


2016–17 Budget

2017–18 Estimate

2018–19 Estimate

Blood primary site 5 5 5 5 5

Blood secondary site 79 79 79 79 79

Single step manufacturer of human tissue

10 24 24 24 24

Class 2 biological products 14 15 15 15 15


$’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue


Total A 2.0 2.2 2.3 2.3 2.4

B: Expenses16

Direct 1.8 1.8 2.0 2.0 2.1

Indirect 1.5 1.5 1.7 1.7 1.7

Total B 3.3 3.2 3.7 3.7 3.8

Surplus (deficit) (1.3) (1.0) (1.5) (1.4) (1.4)


Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al 1.8

Historic

al 1.8

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al 1.5

Historic

al 1.5

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic

al

Historic


Historic


Historic

al

Historic

al

Historic

al

Historic

al docu

ment

documen

t79

documen

t79

documen

t

documen

t

documen

t24

documen

t24

documen

t

documen

t

documen

t

documen

t15

documen

t15 15

documen

t15

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t2016

documen

t2016–

documen

t–17

documen

t17

documen

tBudget

documen

tBudget

documen

t

$’m

documen

t

$’m

documen

t

documen

t2017

documen

t2017–

documen

t–18

documen

t18

documen

tEstimate

documen

tEstimate

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

2.2documen

t

2.2documen

t

documen

t

documen

t

documen

t

2.2documen

t

2.2documen

t

documen

t

documen

t

documen

t



of 35

7. Other activitiesRevenue and expenses 2014–15

Actual $’m

2015–16 Forecast

$’m

2016–17 Budget

$’m

2017–18 Estimate

$’m

2018–19 Estimate

$’m

A: Revenue

Revenue 8.0 2.1 2.0 2.0 2.0

Total A 8.0 2.1 2.0 2.0 2.0

B: Expenses

Expense 4.4 2.1 2.0 2.0 2.0

Total B 4.4 2.1 2.0 2.0 2.0

Surplus (deficit) 3.6 0.0 0.0 0.0 0.0

Historic

al docu

ment

documen

t

documen

t

documen

t2.0

documen

t2.0

documen

t

documen

t

documen

t2.0

documen

t2.0

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t2.0

documen

t2.0

documen

t

documen

t

documen

t

documen

t

documen

t2.0

documen

t2.0 2.0

documen

t2.0

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

0.0

documen

t

0.0

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t

documen

t



of 35

Appendix 2 - Schedule of fees and charges w.e.f 1.7.2016

2016-17 TGA fees and charges can be found using the URL below:

https://www.tga.gov.au/schedule-fees-and-charges

Historic

al docu

ment

https://www.tga.gov.au/schedule-fees-and-charges

Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6203 1605 https://www.tga.gov.au

Reference/Publication #

Historic

al docu

ment

mailto:[email protected]

https://www.tga.gov.au/

cost recovery implementation statement 2016-17 · cost recovery implementation statement 2016-17...

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