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TGA key performance indicators January to June 2014

Version 1.0, August 2014

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Therapeutic Goods Administration

Version history Version Description of change Author Effective date

V1.0 Original publication TGA August 2014

Copyright © Commonwealth of Australia 2014 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]>.

TGA key performance indicators: January to June 2014 of 20

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TGA key performance indicators As a part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through the effective and timely administration of the Therapeutic Goods Act 1989, through which the Australian Government aims to:

• ensure that therapeutic goods are safe, effective and of high quality

• participate in international harmonisation and work sharing, and

• continue the therapeutic goods reform process.

We are guided by the TGA Strategic Statement: 2012-2015 in delivering these outcomes.

Our performance against our broad strategic intent is measured through eight key performance indicators (KPIs):

1. Stakeholder communication, education and satisfaction

2. Premarket business operations

3. Postmarket business operations

4. Organisational health

5. Financial performance

6. Statutory obligations

7. International cooperation, and

8. Decision making.

The KPIs and the specific measures that are used to report against each KPI have been endorsed by the Australian Therapeutic Goods Advisory Council, following consultation with the TGA-Industry Consultative Committee.

This KPI report covers aspects of our performance between January and June 2014. This is the first KPI report that provides information about all agreed reporting measures.

Detailed measures of our pre- and postmarket business activities are documented in our Half-yearly performance reports, which are provided to members of the TGA-Industry Consultative Committee and published on the TGA website.


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1. Stakeholder communication, education and satisfaction We demonstrate our performance against this KPI in the following three different areas:

1.1 Improved community, health professional and industry understanding of TGA’s role

Reporting measure Jan – Jun 2014

Jul – Dec 2013

Number of visitors to the TGA website 1,665,669 1,573,227

Top 5 web pages viewed in this reporting period:

Home (home page)

Children's Panadol 1-5 years suspension

Plexus Slim Accelerator capsules and Plexus Slim Accelerator 3 Day Trial pack

Current year alerts

Recommended paracetamol doses

These website visits represent only about one half of the total number of visitors. There is therefore a wide range of information that visitors are viewing when they access our website.

371,264

188,240

60,489

43,976

43,275

367,011

209,650

62,721

40,651

40,663

Number of TGA participations in key stakeholder forums, either as speakers or through exhibits

22 More than 20


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http://www.tga.gov.au/index.htm

http://www.tga.gov.au/safety/alerts-medicines-childrens-panadol-suspension-131204.htm

http://www.tga.gov.au/safety/alerts-medicine-plexus-slim-accelerator-capsules-130716.htm

http://www.tga.gov.au/safety/alerts-medicine-plexus-slim-accelerator-capsules-130716.htm

http://www.tga.gov.au/safety/alerts-current.htm

http://www.tga.gov.au/consumers/information-paracetamol-doses.htm


1.1 Market research on our stakeholders We published two reports about market research conducted in 2013, Market research: Informing TGA education and communication activities on 11 February 2014. The TGA will conduct a targeted survey in the second half of 2014 with similar participants to measure whether there are improvements in stakeholder understanding of our role.

Figure 1 Stakeholders with good or excellent knowledge of the TGA

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Consumers (n=759)

Health Professionals(n=100)

Industry (n=125)

The consumer, health professional and industry participants in the research were comprised of:

• Consumers including everyday consumers and consumers who work within health related industries, such as beauty therapists or fitness trainers

• Health professionals including general practitioners, specialists and practice managers, pharmacists, nurses, midwives, dental practitioners and allied health practitioners and complementary healthcare practitioners

• Industry including sponsors and manufacturers of therapeutic goods, regulatory affairs consultants and industry association representatives.

In addition, from 12 to 22 June 2014, we measured the level of stakeholder satisfaction with our consultation processes using an online survey consisting of four questions, designed to elicit both qualitative and quantitative data. The survey was only open to invited participants who had participated in consultation activities during the past 12 months. Results from this survey are provided in Table 1.2.


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http://www.tga.gov.au/about/tga-communication-market-research.htm


1.2 Stakeholder engagement and satisfaction with TGA consultative processes

Reporting measure Jan – Jun 2014

Jul – Dec 2013

Number of consultations completed during the reporting period1 1 8

Median number of submissions received for consultations 9 16 (range 5-1276)

Percent of submissions and TGA responses published on the TGA website in target timeframes.2 Submissions and responses to three consultations were published during the reporting period.

100% 100%

Number of subscribers to all TGA email lists Number of subscribers to consultation email list

9169 592

7915 554

Number of stakeholders who were satisfied or very satisfied with our consultative processes

75% Not applicable3

1 A consultation about the review of the low value turnover exemption scheme was completed during this reporting period. 2 We aim to publish consultation submissions and the TGA response within two weeks of noting or advice from the Assistant Minister for Health, where applicable. 3 This survey was conducted for the first time during the current reporting period.

Figure 2 Public contact team performance

The Public Contact Team (PCT) is our first point of contact for enquirers approaching the TGA. Under TGA’s customer service standards, the PCT aims to respond to voicemail messages within two working days, and to respond to emails (either through a direct response or referral to regulatory areas for appropriate action) within five working days.

705 1322

2904

3503

1149

1257

500

1500

2500

3500

4500

5500

6500

Jan - Jun 2014 Jul - Dec 2013

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Email responses

Referral of emails toregulatory areasVoicemail messages

The PCT responded to 100% of email and voicemail enquiries during the reporting period within the specified timeframes. There was a peak in enquiries managed by the PCT during the last reporting period due to a shortage of a critical medicine. The number of less complex enquiries to the PCT reduces as improved information is made publicly available on the TGA website.


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1.3 Performance against TGA customer service standards

Time taken to respond to complaints Jan – Jun 2014

Jul – Dec 2013

Number of complaints received by email

Median time taken to respond (days)

5

5

6

5

Complaints received by telephone

Time taken to respond (days)

2

0–2

2

1–5


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2. Premarket business operations The TGA makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. This KPI provides evidence about whether we are enabling timely access to therapeutic goods for the Australian public.

We aim to ensure that all of the applications for market authorisation of therapeutic goods are processed within target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good. Some of these targets are specified in the legislation. Timeframes exclude ‘hold times’ where the TGA is awaiting a response from an applicant following a request for information, and includes any time for committee consideration.

Premarket business operations Jan – Jun 2014

Jul – Dec 2013

Prescription medicines

Applications lodged under the prescription medicines registration process (‘Category 1’ applications) processed within the legislated timeframe (255 working days)

206 (99.5%) 230 (100%)1

Quality related evaluations (‘Category 3’ applications) processed within the legislated timeframe (45 working days)

754 (100%) 792 (100%)1

Non-prescription medicines: new applications2

N1 (target timeframe = 45 working days) 131 (98%) 97 (80%)

N2 (target timeframe = 75 working days) 2 (100%)




Non-prescription medicines: change applications2

C1 (target timeframe = 20 working days) 184 (84%) 248 (92%)

C2 (target timeframe = 64 working days) 169 (98%) 176 (66%)

C3 (target timeframe = 120 working days) 6 (100%)

C4 (target timeframe = 170 working days) 3 (100%)

Complementary medicines3

Registered complementary medicines (mean approval time; working days)

04 N/A

New substances for listed medicines (mean approval time; working days)

225 N/A

Medical devices

Conformity assessments processed within the target timeframe (255 days)

137 (100%) 87 (100%)


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http://www.tga.gov.au/industry/pm-argpm-process.htm


Premarket business operations Jan – Jun 2014

Jul – Dec 2013

Non-compulsory Application Audits processed within the target timeframe (30 working days)

478 (38%) N/A

Level 1 Application Audits processed within the target timeframe (30 working days)

16 (60%) N/A

Level 2 Application Audits processed within the target timeframe (60 working days)

205 (60%) N/A

In vitro medical diagnostic tests

Conformity assessments processed within the target timeframe (255 days)

24 (100%) 15 (100%)

Non-compulsory Application audits processed within the target timeframe (60 working days)

6 (33%) N/A

Mandatory technical file review processed within the target timeframe (60 working days)

69 (91%) N/A

1 The total number of prescription medicines applications processed during the period June to December 2013 has been revised from values provided in the last KPI report. 2 Data for new and change applications were reported differently prior to 2014. Further details of the different types of applications for non-prescription medicines are available in the Australian Regulatory Guidelines for Non-prescription Medicines. The different types of application types for non-prescription medicines are as follows: • N1: An application submitted as a ‘Clone’ • N2: An application which complies with an over-the-counter medicine monograph • N3: New application for a ‘generic’ medicine other than those ‘generic’ applications in levels N1, N2 or N4 • N4: An application for a ‘generic’ medicine where the medicine:

– is included in Appendix X (but which is not a level N1 application) and/or – includes an umbrella branded product name where the umbrella segment is categorised as requiring a

higher level of assessment1 and/or – requires supporting safety and/or efficacy (clinical/ toxicological) data or a justification for not providing

such data. • N5: An application for a new product that is an extension to a ‘Generic category’ product or an application for a

product containing a new chemical entity as an active ingredient. • C1: Quality and non-quality changes • C2: Quality changes or non-quality changes - no safety & efficacy data required • C3: Umbrella branding - higher level of assessment or non-quality changes - safety & efficacy data may be

required • C4: Non-quality changes – data are required. 3 Approval times are calculated from receipt of application until Delegate’s decision. 4 There were no approvals for registered complementary medicines during the reporting period. N/A = not applicable. These measures are reported for the first time in this KPI report.


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http://www.tga.gov.au/industry/otc-argom.htm


3. Postmarket business operations This indicator demonstrates whether TGA’s work supports the continued availability of therapeutic goods on the Australian market that are safe, effective and of high quality. The success of many of these measures is underpinned by reporting of adverse events by consumers, health professionals and industry.

3.1 Product cancellations Figure 3 Cancellations by the TGA of products following a compliance review

Since August 2012 details of cancellations of listed medicines following a compliance review have been published on the TGA website. Details of cancellations of medical devices have been published on the TGA website since July 2013.

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Medical devices


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3.2 Medical devices Figure 4 Triage and investigation of medical device incidents

Due to the complex nature of some investigations, it is not expected that all investigations would be completed within the 90 day target. For example, delays can occur while waiting on input from third parties.

100 100 82 84

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Incident reports triagedwithin 30 days

Incident reports closed outwithin 90 days


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3.3 Other postmarket activities

Postmarket business operations Jan – Jun 2014

Jul – Dec 2013

Regulatory compliance

Outcomes of completed investigations of alleged offences: • Warning issued1 • Goods released under Personal Import Scheme • Referred to another part of TGA • Referred to another department or agency • Import treated as abandoned goods by Customs • No offence detected

371 33 8 8 0 100

179 22 7 17 1 84

Cases of deliberate non-compliance referred to the Commonwealth Director of Public Prosecutions for criminal prosecution

3 0

Decisions in relation to complaints about advertising of therapeutic goods

11 N/A

Public information on inappropriate unlisted therapeutic goods 40 N/A

Percentage of TGA actions that took place within target timeframes

Percentage of priority laboratory testing, identified as a result of safety issues, completed within target timeframes

96% N/A

Class I and II recalls when they are indicative of a safety concern for: • Medicines • Medical devices • Biologicals The target timeframe for initial review of Class I and II recalls is two working days. Non-compliance of listed medicines, where a safety issue has been identified through targeted or random review Safety signals identified through adverse event reporting and other surveillance activities for: • Medicines and biologicals3 • Medical devices4

92% 97% 100% 02 95% 100%

N/A

1 Warnings were separated under two different categories in the previous KPI report. 2 There were no actions relating to safety issues identified through targeted or random review during the reporting. 3 The target timeframe for risk assessment and triage of safety signals for medicines and biologicals is 30 days. Processes for initial review of all potential safety signals are constantly being refined and target timeframes for the review of potential safety signals for medicines and biologicals have only been introduced during this reporting period. 4 The target timeframe for risk assessment and triage of safety signals for medical device incidents is 30 days. N/A = not applicable. These measures are reported for the first time in this KPI report.


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4. Organisational health This indicator measures whether we are able to attract, develop and retain a professional workforce that can respond to current and emerging regulatory needs.

4. Performance against measures of organisational health Jan – Jun 2014

Jul – Dec 2013

Attracting staff: our success in recruiting the right staff to vacant positions

Number of positions unfilled 90 days after advertising Sixteen positions were advertised and filled during this period.

0 0

Developing our staff: the training we provide to develop and maintain the skills of our people, and activities undertaken to keep them informed

Number of corporate training days per number of full-time equivalent positions

1.0 0.8

Percent of medical staff that attended at least one professional development activity in the last six months

100% 100%

We keep staff informed through two primary internal communication channels: the TGA Daily and the TGA Weekly.1 Number of TGA Weekly disseminated (weekly for 19 weeks during this reporting period)2 Number of TGA Daily disseminated (five days/week)

100% 100%

100% 100%

1 Ad hoc messages are also sent directly to staff outside these two channels as the need arises. 2 TGA weekly editions were not published during the peak holiday periods after Christmas or over the Easter period. We use other internal communication methods, such as the TGA Daily, to maintain continuity of internal communications.

Figure 5 Surveys of staff satisfaction with the TGA and the work they do

TGA staff are surveyed annually by the Australian Public Service Commission. Results from the 2014 staff survey will be available for the next KPI report.

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71

62

67

56

58

60

62

64

66

68

70

72

Staff that recommend the TGA as agood place to work (%)

Staff that agree that the work theydo is important for the public (%)

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TGA

APS


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5. Financial performance We are required by the Government to fully recover our operating costs for all activities that fall within the scope of the Therapeutic Goods Act 1989 (the Act), including the TGA's public health responsibilities. This indicator measures our financial performance.

5. Financial performance

Total revenue Total expenditure

Time period Actual ($’000)

Budget ($’000)

Variance (%)

Actual ($’000)

Budget ($’000)

Variance (%)

Jul 2013 – Jun 2014

132,564 133,161 -1% 133,065 133,470 0%

Jan – Jun 2014 64,369 65,880 -2% 69,011 65,914 5%

Jul – Dec 2013 (year-to-date)

68,195 67,281 1% 64,054 67,556 -5%

Note: target budget variance is ±5%.

The 2013-14 financial results are subject to audit by the Australian National Audit Office (ANAO) and are therefore in draft. The draft result was in line with budget for both revenue and expenses with an operating deficit of $0.502m against a budgeted deficit of $0.309m. The budgeted deficit represented depreciation on assets created under the collaboration with New Zealand that was not recovered from industry.

Lower volumes of prescription medicine evaluations reduced revenue in the latter half of the financial year. The higher level of expenditure in the second half of the financial year was foreshadowed in the last KPI report and offsets lower employee costs in the first six months.

Areas of increased expenditure in the second half of the year included external service providers, planned property improvements (as required under our leases) and records storage transition costs.


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6. Statutory obligations 6.1 Performance in addressing audit findings Outcome

Financial audits Jan – Jun 2014

Jul – Dec 2013

Outcome of the financial audit1 Not applicable

Unmodified

Percentage of category ‘A’, ‘B’ and ‘C’ findings addressed within target timeframes

Not applicable

100%

Percentage of management responses completed prior to publication of audit report

Not applicable

100%

Performance audits

Percentage of management responses completed prior to publication of audit report

100%2 No performance audits

1 Financial audits are undertaken annually, at the end of June. Results for the 2013-14 audit will be provided in the next KPI report. 2 The ANAO completed one performance audit on the TGA titled ‘Administering the Code of Good Manufacturing Practice (GMP) for Prescription Medicines’. The ANAO reported that the TGA had been generally effective in applying the Code of GMP for prescription medicines manufacture or supplied in Australia. In its Audit Report of 7 May 2014, the ANAO made two recommendations related to improving the TGA’s processes for recording its decisions and capturing management information.

6.2 Performance in meeting other statutory obligations Jan – Jun 2014

Jul – Dec 2013

Compliance with on time payment policy for small business: Relevant invoices paid within 30 days

93% 98%

Compliance with freedom of information legislation: Requests processed to completion within legislated timeframes1

100% 100%

Progress towards the Australian Government Digital Transition Policy: applications and submissions received by the TGA that are available in an electronic form2

62% 48%

Percent of compliant regulation impact statements completed by the TGA (none were completed) Percent of compliant cost-recovery impact statements completed by the TGA (six were completed)

Not applicable 100%

100% 100%

1 A decision on access to information must normally be advised within 30 days of receipt of the freedom of information request. However, this timeframe may be varied in certain defined circumstances by TGA or the Information Commissioner. 2 The Australian Government’s Digital Transition Policy aims to move all Government agencies to digital recordkeeping. This is an average figure across various product streams on applications and submissions. Compliance is as high as 97% for one submission type. TGA's target is 100% by December 2015.


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7. International cooperation TGA has strong active working relationships with most major overseas regulators. These relationships help us safeguard public health in Australia through harmonisation, information sharing and cooperation.

Many of our efforts towards international cooperation are achieved by collaboration with international regulators through formal forums and consortia.

7.1 Participation in international harmonisation activities

Good Manufacturing Practice inspections

Contributed to the review of Pharmaceutical Inspection Cooperation Scheme (PIC/S) strategy and policies, as the basis for mutual recognition of decisions around Good Manufacturing Practice (GMP) inspections.

International Medical Devices Regulators Forum (IMDRF)

Review of the National Competent Authorities Report Exchange Program, and refined the program as follows:

• Focussed the exchange of information with other regulators to issues associated with unanticipated serious public health threats.

• Improved the mechanism through which regulators request information about a device.

Regulated Product Submission: developed agreed content and format for electronic submission of dossiers, including a single table of contents and unique device identifiers.

Software as a Medical Device: adopted key definitions and developed a proposed framework for risk categorisations and corresponding controls. The TGA and partner regulators are maximising convergence of regulations internationally.

International Generic Drug Regulators Pilot (IGDRP)

Developed mechanisms for participating regulators to utilise similar approaches for the review of application for marketing of generic medicines.

Developed a register of differences in regulatory frameworks for pre-market authorisation of generic medicines across participating countries to maximise the use of evaluation reports in work-sharing.

Developed evaluation templates for assessment of biowaivers.

As project lead, developed an agreed program of work for Active Substance Master Files / Drug Master Files and implemented work sharing for their evaluation.


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7.1 Participation in international harmonisation activities

International Coalition of Medicines Regulatory Authorities (ICMRA)

As a member of the Management Committee, contributed to the development of governance arrangements, communication strategies and regulatory work programs for the new coalition.

As project lead, established an agreed work program for generic medicines with participating countries in March 2014. Identified opportunities for work-sharing by providing strategic oversight and direction to existing initiatives for convergence of technical requirements. Led the development of a communication strategy for a project that aims to streamline market authorisation for generic medicines.

As a member of the GMP Inspections project, contributed to the development of an agreed workplan with participating countries. As lead on a number of sub-projects, continued collaborating with participating regulators regarding harmonisation of and equivalence in GMP inspections, with a view to mutual recognition of assessments.

Direct collaboration with other regulators

Generic Medicines

Continued collaborating with Health Canada, Health Sciences Authority of Singapore and Swissmedic to develop simplified information sharing to facilitate work sharing for assessment of Drug Master Files in each country.

Accepted as an assessor in the European Directorate for the Quality of Medicines and HealthCare procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia. Working with international regulators to develop common standards, guidelines and regulatory requirements will reduce the time to market for generic medicines.

Implemented work sharing with Health Canada in the area of premarket assessment of generic medicines through the routine exchange of evaluation reports.

Orphan Medicines

Agreed to share assessment reports on orphan drugs with the European Medicines Agency.

New Zealand collaboration

Worked with New Zealand to align guidance documents on changes to paediatric dosage instructions for liquid preparations containing paracetamol or ibuprofen.

TGA and Medsafe developed and published a common list of colouring substance allowed for use in medicines for oral and topical use.


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7.2 Collaboration and work-sharing with other regulators Jan – Jun 2014

Jul – Dec 2013

Exchange of bioequivalence reports1 and monographs to support generic prescription and OTC medicines registration, respectively.

Number of monographs developed with Health Canada to support OTC medicines registration. We implemented a monograph for topical nasal decongestants, which was previously developed with Canada.

0

2

Number of desktop clearances for manufacturers undertaken in place of inspections, taking into consideration regulatory decisions by other comparable regulators.2

1481 2058

Work sharing and single inspections under the Medical Devices Single Audit Program (MDSAP):

Inspections under the MDSAP are yet to commence.3

Not applicable

Not applicable

Number of postmarket signals for prescription medicines received from international regulators during the reporting period to trigger appropriate early warnings.

We also issued one risk communication during the reporting period, based on a signal received prior to January 2014.

0 2

1 We continue to monitor this opportunity for work sharing, particularly regarding some aspects of the biopharmaceutic assessment report in circumstances where the bioequivalence studies submitted to Health Canada and TGA are performed at the same clinical sites and the bioanalysis is done by the same bioanalytical laboratory. Opportunities for harmonisation efforts in other related areas were explored, including Biopharmaceutic Classification System-based biowaivers. 2 Approximately 95% of overseas manufacturer clearances are issued via desktop assessments that take into account overseas regulator decisions. 3 We participated in the pilot program launch and conducted one on-site Head Office and two on-site Critical Location assessments of candidate Auditing Organisations in North America and Europe. We continue to participate in the development of documentation for MDSAP pilot policy and procedures. We intend to incorporate outputs from audits performed by Auditing organisations into our business processes to reduce duplication of audits and cost to sponsors wherever possible.


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8. Decision making Internal reviews are undertaken when someone affected by a decision requests a review of the decision by the TGA under Section 60 of the Therapeutic Goods Act 1989. In some cases, external review of TGA decisions by the Administrative Appeals Tribunal (AAT) is instead or additionally requested.

8. Internal and external review of TGA decisions

Jan – Jun 2014 Jul – Dec 2013

Internal review Number Percent Number Percent

We make more than 34 000 regulatory decisions every year. Internal reviews are usually only sought on a small number of these decisions (less than 1%). Number of requests for internal review processed during the reporting period: Regulatory decisions subject to internal review, for which the original decision is: • initial decision confirmed • initial decision revoked, or revoked and

substituted • initial decision remitted • internal review request withdrawn. Additional information was provided to the internal review delegate in four of the seven cases where the initial decision was revoked or revoked and substituted. All internal reviews during the reporting period were completed within target (legislated) timeframes.

25 15 7 0 3

100% 56% 32% 0% 12%

22 11 8 1 2

100% 50% 36% 5% 9%

External review Number Percent Number Percent

One matter referred by sponsors to the AAT was decided during the reporting period. Number of matters referred to the AAT, where the outcome is indicative of an issue about quality of the initial decision.1

0

(0%)

0

(0%)

1 This includes substantive regulatory decisions: • to not include products on the Register • to remove products from the Register • to grant or revoke a manufacturing licence or conformity assessment certificate.


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Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605 http://www.tga.gov.au

Reference/Publication R14/938204

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mailto:[email protected]

http://www.tga.gov.au/

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