Session A03: Hints and Tips for Acceptance of your Prescription Medicines Submission(s)

Melissa Quinn B.Pharm (Hons) Director & Senior Pharmacist - Application Management & Exports Section Prescription Medicines Authorisation Branch Medicines Regulation Division Therapeutic Goods Administration ARCS 21 August 2018

Outline • Prescription Medicines: Regulation Basics • General Workflow for Screening Applications • The Registration Process • Legislative Basis for Applications • Application Categories • How to Submit Applications • Pre- application Activities • Focus on Category 1 Applications • Application Acceptance • Mandatory Requirements – Overview • Fees and Charges • So…What Goes Wrong? • How We Can Help • What is TGA Currently Working On? • Final Hints and Tips • Questions?

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Some Stakeholder Management Things this presenter is not: An IT or legal expert!

– When you encounter issues with forms or IT systems, please always give feedback so we can resolve as quickly as possible.

– Resolutions for existing IT problems will not be provided in this talk but I am happy to take a list of questions on notice!

– Many legislation related queries are very situation specific and the TGA generally cannot provide external stakeholders with legal advice, but can provide some direction/guidance when appropriate.

– It is important for you to understand the relevant legislation and seek your own legal advice as required.

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Prescription Medicines: Regulation Basics

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Prescription Medicines Registration

Pharmaceutical Benefits Division

Product Billing & Industry Assistance

Section

Regulatory Practice & Support Division

Scheduling & Committee

Support Section

Medicines Regulation Division

Medical Devices & Product Quality Division

PM Registration Processes

Prescription Medicines

Authorisation Branch

Scientific Evaluation Branch

Pharmacovigilance and Special Access

Branch

Laboratories Branch

Manufacturing Quality Branch

Prescription Medicines Authorisation Branch Structure • The Prescription Medicines Authorisation Branch is comprised of 6 Clinical Evaluation Units (CEU). • Each unit is responsible for assessing prescription medicines applications within particular therapeutic areas.

CEU 1

• Analgesia • Neurological disorders • Psychiatric/Psychological/

Behavioural disorders • Anaesthesia • Gastrointestinal disorders • Nutrition • Disorders of the mouth • Disorders of the skin • Poisoning o Opioid antagonists

CEU 2

• Infectious diseases • Vaccination against infectious

disease • Immunological disorders • Other o radiological agents (e.g. contrast

media) o adjuncts to

radiopharmaceuticals and contrast media use

o diagnostic tests for infections o allergens (diagnostic or

therapeutic) o antivenenes o radiopharmaceuticals for cancer

(diagnostic)

CEU 3

• Cardiac disorders • Lipid disorders • Inherited metabolic

disorders • Vascular disorders • Musculoskeletal disorders • Disorders of the male

reproductive system • Renal & urinary tract

disorders • Disorders of the ear • Poisoning o Heavy metal poisoning o Cyanide poisoning

CEU 4

• Neoplastic disorders o solid tumour oncology o hormonal effects of

functioning carcinoid neoplasms

o Radiopharmaceuticals for solid tumours (therapeutic)

CEU 5

• Contraception • Infertility • Obesity • Paget’s disease of bone • Endocrine disorders • Disorders of the female

reproductive system • Pregnancy and labour • Fluid & electrolyte

disorders • Disorders of the eye • Respiratory disorders • Disorders of the nose,

paranasal sinuses & upper airway

CEU 6

• Haematological disorders, including haematological malignancies o radiopharmaceuticals for

cancer (therapeutic) • Other o Surgical haemostasis

(plasma products)

Further information can be found in Guidance 4 of the Australian Guidelines for Prescription Medicines (ARGPM)

Branch Overview: Sections

Application Entry Team

Application Support Team Exports

FOI requests

Retrospective performance reporting

KPI reporting Sponsor Pipeline Reporting

(Forecasting) Business improvements and

solutions eCTD reform

B2B Portal Premier Replacement

External evaluator procurement Reforms implementation

Associated legislative and guidance change

Change management AusPAR preparation and

publication

Business Systems Review & Reporting

aet.application.entry.team@health.gov.au ast.application.support.team@health.gov.au

Application Entry, Support & Exports

Transparency Reforms & Evaluation Support

Application & Advisory Management

Case Management

Media and ministerial enquiries

Secretary of Advisory Committee for Medicines

International work-sharing Streamlined Submission

Review Pre-submission meetings

streamlinedsubmission@health.gov.au

General workflow for screening applications Application received and application fees paid

Date = 40 working day start

Application screened by AESE (administrative) and assigned to a case manager for further technical screening

Application has minor deficiencies

Opportunity to remedy minor deficiencies

Deficiencies unresolved

Application has critical issues/

unresolved deficiencies

Notice of refusal sent

Deficiencies resolved

Application acceptable

Notice of acceptance sent

Payment of evaluation fees CMES 7

Evaluation: Key Phases Phase Description

1. Pre-submission Applicant provides necessary information on scope and scale of application. Assists resource planning

2. Submission TGA completes activities in preparation for application evaluation. Letter of application acceptance. NOTE: Application MUST be in the Form approved by the Secretary.

3. First round assessment Evaluators assess the dossier

4 Consolidated Section 31 requests TGA will consolidate all questions from evaluators and send to applicant. Stop Clock. Rolling questions used for Priority

5. Second round assessment TGA evaluators assess the application in view of the response to questions

6. Expert advisory review Delegate may seek independent advice after considering all evaluation reports

7 TGA Decision TGA delegate makes a decision

8. Post-decision Administrative and regulatory activities are completed

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• Multiple submission pathways ranging from 120-220 target days to provide efficiencies in market approvals Priority Review (Jul 2017) = substantial evidence & complete data dossier Provisional Approval (Mar 2018) = early clinical safety & efficacy data Comparable Overseas Regulator (COR) report-based process (Jan 2018)

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The Registration Process A submission to register a new prescription medicine is supported by:

1. Quality data: for both the drug substances (drug master files etc.) and for the dosage form

2. Nonclinical data (if required)

3. Clinical data: might be evidence of bioavailability (i.e. the extent and rate of release from the dosage form: in vivo or sometime in vitro)

4. Evidence of Good Manufacturing Practice is required.

Data required outlined in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

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Applications • Set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.

– Section 9C – request for copy of ARTG entry

– Section 9D – request to vary information about an ARTG entry

– Section 14 – exemption from compliance with a standard

– Section 23 – registration or listing (in this case each application results in a single registration or listing or inclusion of a separate and distinct product within a grouped registration or listing)

– Section 61 (6) – request for information from ARTG

– Regulation 14 – transfer of goods registered/listed

– Regulation 14A – reassignment of registration/listing numbers

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Application Categories • Regulations 16A to 16G, includes statutory processing times.

• Category 1 applications:

– An application for a new medicine or a change to a medicine constitutes a Category 1 application if it does not meet the requirements of Category 3

• Comparable Overseas Regulator (COR) report based process:

– Implemented on 2 Jan 2018 as part of MMDR reforms

– Builds on previous Category 2 process.

• Category 3 applications:

– Changes to quality data of a medicine already in the ARTG

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How to Submit Applications • Obtain access to TGA Business Services www.tga.gov.au/tga-business-services.

– Prescription medicines applications are lodged via the TBS portal.

– Applicants need to be set up in the TGA client database in order to lodge applications.

• Applicants should ensure their company generic email address has been added to the TGA client database.

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Pre- application Activities • Approved terminology for medicines (ingredient names)

– Look at how to propose a new ingredient name https://www.tga.gov.au/proposing-new-ingredient-name

• Pre-submission meetings

– Look at requirements outlined in pre-submission planning form www.tga.gov.au/form/pre-submission-planning-form-ppf

• Other considerations

– Product Information: New format as of 2 January 2018

– Consumer Medicine Information (CMI)

– Patent certification and data exclusivity

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Category 1 Applications New chemical/biological entity or biosimilar medicine OR Change(s) to an existing good that MAY create a separate and distinct good on the ARTG • Applies to:

– applications for new dosage forms – new fixed–dose combinations – new strengths and new generic products – extensions of indications – amendments to the Product Information (type J, otherwise 9D) – Additional trade names (45 working days, no longer Cat 1) – Changes to product information

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Category 1 Applications • Major variation, for therapeutic goods of a particular kind, means a change to:

a) the strength, as recorded in the entry in the Register; or

b) the dosage, the recommended dose regimen or the maximum daily dose; or

c) the dosage form; or

d) the route of administration; or

e) the intended patient group

f) some types of minor variations (type G and H)

Requires evaluation of clinical, pre-clinical and/or bioequivalence data.

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Comparative Overseas Regulator (COR) (previously known as Category 2)

• Implemented on 2 January 2018 • Must be from a country/jurisdiction determined to be ‘comparable’

COUNTRY OR JURISDICTION REGULATORY AUTHORITY

Countries

Canada Health Canada

Singapore Health Science Authority Singapore (HSA)

Switzerland SwissMedic

United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)

United States Food and Drug Administration (FDA)

Jurisdictions

European Union European Medicines Agency (EMA) - centralised and decentralised processes

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Comparative Overseas Regulator (COR) Open to applications where the medicine has received full overseas marketing approval following a de novo evaluation. COR approach A (target time frame of 120 working days)

• identical medicine and manufacturing to that approved by the COR, with evidence of compliance with Good Manufacturing Practice (GMP)

• the full overseas marketing approval for the medicine is no older than 1 year • aside from the label, PI and RMP (where required), no additional evaluation of Australian specific data is

required. COR approach B (target time frame of 175 working days)

• TGA evaluation of certain data, in addition to the label, PI and RMP. • The amount and type of additional data requiring evaluation will determine whether the application is best

processed under the COR-B approach or as a Category 1 application. • E.g. stability data, validation data for an additional manufacturing site and updates to pivotal studies that

support the proposed indication.

See: https://www.tga.gov.au/publication/comparable-overseas-regulators-cors-prescription-medicines

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Category 3 Applications • Minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is

a major variation) to:

a) the formulation, composition or design specification; or

b) the container for the goods;

c) any other attribute of the goods that results in the goods being separate and distinct

• Other minor variations:

– Correction of an ARTG entry that is incomplete or incorrect

– Safety-related requests (SRR), with and without data, Self Assessable Request (SAR)

– Minor editorial Change (MEC), Notifications

More notifiable changes (enhancements) are coming in 2019/2020

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Example: Minor Variations Applications Launched July 2017

• Log on to the TBS portal • Select Variation under prescription medicine

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Application Acceptance • See Mandatory requirements for an effective application for Category 1

• See Minor variations to prescription medicines for minor variations

• Application Entry Team conducts an administrative screen of application

– Checks that application fee is paid

• Once accepted for evaluation

– Notifying letter of acceptability and evaluation fee invoice sent to sponsor

– Statutory evaluation period applies

– Application lapses if evaluation fee is not paid by due date

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Dossier Submission For Registration • Common Technical document (CTD)

– A set of specifications for a dossier for the registration of medicines.

• General dossier requirements www.tga.gov.au/publication/general-dossier-requirements

• eCTD specifications www.tga.gov.au/book-page/ectd-preparation-tools

• Non eCTD electronic submissions www.tga.gov.au/book/organising-nees-submissions

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Guidance • Scientific guidelines

• Forms and templates

• Regulatory decisions and notices for prescription medicines

• www.tga.gov.au/standards-guidelines-prescription-medicines

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Mandatory Requirements • Structure and Format

• Content

– Technical data requirements (Appendix A – specific mandatory requirements https://www.tga.gov.au/book-page/appendix-specific-mandatory-requirements)

– Australian and adopted international guidelines

• Justification of data gaps

• Administrative requirements

Note: – There are no “secret guidelines” but a section can determine that there are other matters which are relevant to an

application, relevant to best practice and risk-management for use in an Australian population – Post-market experience may not be specific enough to manage an identified risk with an application.

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Mandatory Requirements – Overview ITEM REQUIREMENT Language All information must be in English and readable

Measurements Units of measurement must use the metric system (or other appropriate units, such as those generally accepted in clinical practice e.g. SI)

Provision of Module 1 All application dossiers must include Module 1.

Electronic Data Must be submitted in either the eCTD or NeeS format* * note: TGA will likely be moving to eCTD only in the next 2-3 years. Are you ready?

Applications that have previously been rejected by the TGA or withdrawn by the applicant before a decision by the TGA Delegate.

• Applicants must identify in the letter of application how the deficiencies identified in the previous application have been addressed.

• To ensure that the data to be evaluated by the TGA are the current data relevant to that application, the applicant must provide:

• A complete, up-to-date electronic data set for each new application. • A complete new Module 1 plus replacement for those volumes that have changed, plus any additional

volumes. The letter of application must specify which modules and data volumes from the previous application should be used for the current application.

• Data previously submitted to us must be clearly identified in the Table of Contents of the dossier.

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Module One ITEM REQUIREMENT Cover Letter Must be included in Module 1.0.1 for all regulatory activities (submissions) and for each sequence associated with that regulatory activity.

Lifecycle management tracking table Must be included in Module 1.0.2 for all regulatory activities and for each sequence associated with that regulatory activity provided in the eCTD format.

Table of Contents Must be included for all regulatory activities and for each sequence associated with that regulatory activity provided in the NeeS format

Letter of Authorisation If an applicant is acting on behalf of another applicant, a letter of authorisation must be provided. Where the applicant is using another company's name and/or livery on labels, a letter of authorisation from the company owning the name/livery must be provided.

Application Form Must be included in Module 1.2.1 for all applications

Literature-based submission documents

If your application partially or completely relies on a literature-based data set include either: • confirm the search strategy used to generate the search output for the application is in full accordance with the search strategy

approved by the TGA; OR • document and include the reasons for all changes if not in full accordance with the search strategy approved by the TGA. Information must be included in Module 1.5.1 in these instances.

Designation applications – supporting documents

To be eligible for the relevant pathway, applicants must provide a copy of the priority or provisional determination letter that was issued by the TGA. The determination must be in force at the time of making the section 23 application. To be eligible for a waiver of the section 23 application and evaluation fees, applicants must provide a copy of the Orphan drug designation letter that was issued by the TGA. The designation must be in force at the time of making the application. Information must be included in Module 1.5.2 in these instances.

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Module One ITEM REQUIREMENT Declaration of compliance with Pre-submission planning form and planning letter

• In Module 1.7.3, applicants must provide a declaration of compliance with the information provided about the application(s) in the PPF (including attachments) and planning letter.

• The declaration must also address any issues that were raised in the planning letter, and identify how the issues were resolved in the application.

Risk Management plan for Australia Include in all regulatory activities for: • a new chemical entity • a new vaccine • an application for provisional registration • a generic medicinal product where a safety concern with the reference medicinal product requires additional risk minimisation

activities. Include an RMP under certain circumstances for other applications as descripted in Risk management plans for medicines and biologicals. The Risk Management Plan must be the current, unaltered EU-RMP and an Australian Specific Annex should be included. An alternative to the EU RMP is acceptable only if there is no current EU-RMP. Include in Module 1.8.2.

Justification for not providing appropriate biopharmaceutic studies

A justification within Module 1.11.2 is required when: • biopharmaceutic data provided have been generated against an overseas reference product. • a BCS (Biopharmaceutics Classification System)-based biowaiver approach is used. • biopharmaceutic data do not cover all the different strengths for a new medicine. • where biopharmaceutic data are required but have not been provided for one or more products. Such a justification must consist of a document that: • provides an accurate, robust and scientific response to each point/heading listed in Biopharmaceutic studies - Justification for not

submitting biopharmaceutic data • provides any other information relevant to the justification in separate section/s, and • addresses any other aspects from relevant EU guidelines adopted in Australia (for example, Guideline on the investigation of

bioequivalence CPMP/QWP/EWP/1401/98 Rev 1). 28

Dossier Documents – Matrix Modules: Module Two (Category 1/COR)

Category 1/category 2 applications - Module 2 TGA's application fee type is … A - NCE B - New

Combination C – Extension of

indication D – New generic

medicine Applying for a … New chemical entity New salt or ester of existing active

ingredient

Similar biological medicinal product

Module 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory Module 2.3 Quality overall

summary Mandatory Mandatory Mandatory Mandatory Not required Mandatory

Module 2.4 Nonclinical overview

Mandatory Mandatory Mandatory Mandatory May be required* May be required*

Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory Module 2.6 Nonclinical

overview Mandatory Mandatory Mandatory May be required* May be required* May be required*

Module 2.7 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory May be required*

*Refer to Module 1 requirements. https://www.tga.gov.au/dossier-documents-matrix-module-2-5

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Dossier Documents – Matrix Modules: Module Two (Category 1/COR)

Category 1/category 2 applications - Module 2 TGA's application fee type is … F - Major variation E - Additional

tradename J - PI Change

requiring evaluation

Applying for a … New strength New dosage form New route of administration

Change in patient group (not decrease)

Change of dosage

Module 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required.*

Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required.*

Module 2.3 Quality overall summary

Mandatory Mandatory May be required.*

Not required Not required Not required May be required.*

Module 2.4 Nonclinical overview

May be required.*

May be required.*

May be required.*

May be required.*

May be required.*

Not required May be required.*

Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required.*

Module 2.6 Nonclinical overview

May be required.*

May be required.*

May be required.*

May be required.*

May be required.*

Not required May be required.*

Module 2.7 Clinical overview May be required.*

Mandatory Mandatory Mandatory Mandatory Not required May be required.*

*Refer to Module 1 requirements. https://www.tga.gov.au/dossier-documents-matrix-module-2-5

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Dossier Documents – Matrix Modules: Module Two (Category 3)

TGA's application fee type is … G - Minor variation, new Register entry H - Minor variation, not resulting in a new

Register Entry Applying for a … Change of formulation New container type Change of tradename

Module 2.1 Table of contents May be required* May be required* Not required May be required* Module 2.2 Introduction May be required* May be required* Not required May be required* Module 2.3 Quality overall

summary Mandatory Mandatory Not required Mandatory

Module 2.4 Nonclinical overview Not required Not required Not required Not required Module 2.5 Clinical overview Not required Not required Not required Not required Module 2.6 Nonclinical overview Not required Not required Not required Not required Module 2.7 Clinical overview Not required Not required Not required Not required

*Refer to Module 1 requirements. https://www.tga.gov.au/dossier-documents-matrix-module-2-5

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Dossier Documents – Matrix Modules: Modules 3-5 (Category 1/COR) Category 1/category 2 applications - other modules

TGA's application fee type is …

A - NCE B - New Combination C – Extension of indication

D – New generic medicine

Applying for a … New chemical entity New salt or ester of existing active

ingredient

Similar biological medicinal product

Module 3—Quality Mandatory Mandatory Mandatory Mandatory Not required Mandatory Module 4—Nonclinical Mandatory Mandatory Mandatory May be required* May be required* May be required*

Module 5—Clinical Mandatory Mandatory Mandatory Mandatory Mandatory May be required* Module 5.3.1 Reports of biopharmaceutic

studies

May be required* May be required* May be required* May be required* Not required May be required*

Module 5.3.2 Pharmacokinetic

studies using human biomaterials

May be required* May be required* May be required* May be required* May be required* Not required

*Refer to Module 1 requirements. https://www.tga.gov.au/dossier-documents-matrix-module-2-5

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Dossier Documents – Matrix Modules: Modules 3-5 (Category 1/COR) Category 1/category 2 applications - other modules

TGA's application fee type is …

F - Major variation E - Additional tradename

J - PI Change requiring evaluation

Applying for a … New strength New dosage form New route of administration

Change in patient group (not decrese)

Change of dosage

Module 3—Quality Mandatory Mandatory May be required* Not required Not required Not required Not required Module 4—Nonclinical

May be required* May be required* May be required* May be required* May be required* Not required May be required*

Module 5—Clinical May be required* Mandatory Mandatory Mandatory Mandatory Not required May be required* Module 5.3.1

Reports of biopharmaceutic

studies

May be required* May be required* May be required* Not required May be required* Not required May be required*

Module 5.3.2 Pharmacokinetic

studies using human biomaterials

May be required* May be required* May be required* May be required* May be required* Not required May be required*

*Refer to Module 1 requirements. https://www.tga.gov.au/dossier-documents-matrix-module-2-5

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Dossier Documents – Matrix Modules: Modules 3-5 (Category 3)

TGA's application fee type is … G - Minor variation, new Register entry H - Minor variation, not resulting in a new Register Entry Applying for a … Change of formulation New container type Change of tradename

Module 3—Quality Mandatory Mandatory Not required Mandatory Module 4—Nonclinical Not required Not required Not required Not required

Module 5—Clinical Not required Not required Not required Not required Module 5.3.1 Reports of biopharmaceutic studies

Not required Not required Not required Not required

Module 5.3.2 Pharmacokinetic studies using human

biomaterials

Not required Not required Not required Not required

https://www.tga.gov.au/dossier-documents-matrix-module-2-5

• Application types G and H are shown as Category 3 application. They may be Cat 1/2 or Cat 3 depending on whether they are supported by clinical, nonclinical or bioavailability data (Cat 1/2) or not (Cat 3).

• Cat 1/2 G and H are not included in the dossier in these table(s). • If nonclinical (Module 4), clinical (Module 5) or bio-availability (Module 5.3) data are submitted, relevant Module 2 summaries and

overviews will be required. • Modules 1.8, 1.9 and 1.11 may also be required, depending on the application.

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Fees and Charges • TGA required to recover all costs through fees and charges for activities within scope of the Act.

– A fee is charged for a service e.g. evaluation of an application

– A charge is a form of tax applied per financial year

• Fees and charges set out in Schedule 9 of the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Charges) Regulations 1990.

• A full list of the fees and charges that apply to prescription medicines can be found on the TGA website: www.tga.gov.au/book-page/prescription-medicines-2

• Further enquiries in relation to fees for prescription medicines should be directed to: AET.application.entry.team@tga.gov.au

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Fees and Charges • The type of fees set will depend on whether TGA requires to evaluate data and the level of effort

associated with that service

• Application type relates to the fees associated with an application and is identified by a letter (for example, A, B or C application types).

• Data requirements determine the fees associated.

• Examples include:

– new chemical entity

– new indication or major variation.

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Fees and charges • Category 1 applications types

A: New chemical or biological entity, biosimilar medicine or New salt/ester of previously approved active ingredients

B: New combination of previously approved active ingredients

C: Extension of indications

D: New Generic medicines

E: Major Variation – Additional trade name

F: Major variation – New strength, new dosage form, new route of administration, change/increase in patient group, change in dosage

J: Change to Product information requiring the evaluation of clinical, non clinical or bioequivalence data

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So…What Goes Wrong? • Incorrect application/submission type • Missing essential data – gross deficiency or insufficiency (such as an entire module missing) • Not meeting required guidelines and standards – including lack of justification for missing data • Nil/expired GMP (when not rectified prior to completion of evaluation process) • Format of reports

– Summaries/unpublished manuscripts instead of full study reports – Documents not in English – Unacceptable dossier format(s)

• Inadequate safety and/or efficacy data – e.g. for the target population, duration of use, indications etc. • Bioequivalence and biowavers – biowavers not appropriate for the formulation, inadequate justification • Unclear cover letters with unclear directions to TGA • Inappropriate bundling of applications/submissions • Fees not paid on time • Not fully responding to identified issues identified in screening or s31 requests 38

How We Can Help

• Email – your assigned case manager, or AET • Pre-submission meetings – USE THEM!

• SME Assist hub

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More information on our website • Australian Regulatory Guidelines for Prescription Medicines

https://www.tga.gov.au/publication/australian-regulatory-guidelines-prescription-medicines-argpm

• Standards & guidelines for prescription medicines – https://www.tga.gov.au/standards-guidelines-prescription-medicines – https://www.tga.gov.au/prescription-medicines-registration-process – https://www.tga.gov.au/publication/common-technical-document-ctd

• Forms for prescription medicine sponsors

https://www.tga.gov.au/forms-prescription-medicine-sponsors

• Regulatory decisions and notices https://www.tga.gov.au/regulatory-decisions-and-notices-prescription-medicines

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What is TGA Currently Working On? • Revisions to the mandatory requirements with a clearer distinction between what is mandatory vs what is a

guideline

• Providing better information and a linkage between which mandatory requirement was not met with any rejection at the entry stage

• A better process for the review and maintenance of EU guidelines that have been adopted (or adopted with annotations)

• Being more rigorous in ensuring that any Cat 1 application (in particular) meets the form required by the Secretary (as enshrined in recent legislative amendments)

• A user guide for e-forms to assist external users

• Compiling a list of the most common issues with applications to update/add to the FAQs as well as resolve any IT related issues being experienced where possible

• Enhancements to the Minor Variations e-form with more variations to become notifiable to the TGA

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Final Hints and Tips: 1. Check if your product is a therapeutic good and what type (e.g. OTC/Prescription)

2. Decide whether you want to have it approved in your name to supply it in Australia

3. Understand the legal requirements for your product to be approved and your legal responsibilities of being a sponsor

4. Find out what type of therapeutic good the product is and review the relevant guidelines

5. Determine if it meets a particular submission pathway and application type

6. Understand the dossier/submission requirements and ensure you have ALL required data

7. Understand what it will cost you

8. Seek further advice if you need it!

Keep your details up to date with TGA (TBS) Use the pre-submission planning session

Consider using the SME Assist tools 42

Questions?

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