TGA key performance indicators · Therapeutic Goods Administration TGA key performance indicators As a part of the Department of Health, the TGA safeguards and enhances the health

TGA key performance indicators July to December 2014

Version 1.0, January 2015

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Therapeutic Goods Administration

Version history Version Description of change Author Effective date

V1.0 Original publication TGA January 2015

Copyright © Commonwealth of Australia 2015 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: July to December 2014 Page 2 of 20

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mailto:[email protected]


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

· 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

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 July and December 2014.

Progress has been made in a number of areas since the last KPI report. In particular, there has been continued improvement in our performance in our stakeholder communication, education and satisfaction. There were also several significant outcomes in our efforts towards greater international harmonisation, information sharing and cooperation.

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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https://www.tga.gov.au/book/attachment-1-strategic-statement-0


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

For this reporting period, website statistics in the table below are split into two separate time periods because we upgraded our reporting software in November 2014. There is a difference between how the reporting software captures and analyses the data and therefore there is not a direct correspondence between the new metrics and visitor numbers reported in previous periods.

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

Reporting measure Jul – Oct 2014 (see below for Nov–Dec 2014)

Jan – Jun 2014

Jul – Dec 2013

Number of visitors to the TGA website 1,196,493 1,665,669 1,573,227

Top 5 web pages viewed in this reporting period:

Home (home page)

Children's Panadol 1-5 years Colourfree suspension

Recommended paracetamol doses

Latest news & updates

Australian Register of Therapeutic Goods

These website visits represent about 46% of the total number of visitors. A wide range of webpages are viewed when visitors access our website.

433,976

39,608

29,427

27,729

24,233

371,264

N/A

43,275

37,082

35,886

367,011

N/A

36,268

40,651

35,613

Reporting measure (using the new metrics software introduced in November 2014)

Nov – Dec 2014

Number of visitors to the TGA website: · Sessions – a period of active engagement by a user with the website · Users – the total number of unique website visitors · Pageviews – a view of a single web page on our website.

370,204 242,987 992,786

Top 5 web pages viewed in this reporting period:

Home page

Australian Register of Therapeutic Goods

Prescribing medicines in pregnancy database

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

Special access scheme

These web pages represent about 14% of total page views.

106,116

11,455

8,370

7,977

7,973

N/A = not applicable. This webpage was created during the current reporting period.


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

https://www.tga.gov.au/alert/childrens-panadol-1-5-years-colourfree-suspension

https://www.tga.gov.au/community-qa/recommended-paracetamol-doses

https://www.tga.gov.au/latest-news-updates

https://www.tga.gov.au/australian-register-therapeutic-goods

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

http://www.tga.gov.au/australian-register-therapeutic-goods

http://www.tga.gov.au/prescribing-medicines-pregnancy-database

http://www.tga.gov.au/alert/plexus-slim-accelerator-capsules-and-plexus-slim-accelerator-3-day-trial-pack

http://www.tga.gov.au/form/special-access-scheme


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

Reporting measure Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

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

28 22 More than 20

Market research on our stakeholders We conducted a targeted survey in the second half of 2014 with consumer, health professional and industry participants to measure whether there are improvements in stakeholder understanding of our role, compared to our previous survey in 2013. 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 (n=1000)

· Health professionals, including general practitioners, pharmacists and nurses (n=90)

· Industry, including sponsors and manufacturers of therapeutic goods, regulatory affairs consultants and industry association representatives (n=80).

Figure 1 Stakeholders with good or excellent knowledge of the TGA

29 22 36 39

86 79

0

20

40

60

80

100

2014 2013

Percent of stakeholders

Consumers

Health Professionals

Industry

Note: there are some slight variations to the 2013 results compared with those provided in the previous report. In the 2014 survey there were some modifications to the structure of selected questions and the composition of the stakeholder groups. The 2013 figures have been recalculated to account for this and ensure a comparable result.

The increase in consumer awareness is likely due to the release of consumer educational materials through various channels including social media and information services provided in doctors’ waiting rooms. The research found a significant increase in awareness of specific aspects of the regulatory system, including adverse event reporting and TGA safety information. Results from the regulated industry surveys were largely unchanged, showing a slight increase in awareness, and we have continued to raise awareness of particular activities, including consultations and the TGA expert advisory committees during this period.


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1.2 Stakeholder engagement and satisfaction with TGA consultative processes

Reporting measure Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

Number of consultations completed during the reporting period

4 1 8

Median number of submissions received for consultations

11 (range 5–80)

9 16 (range 5-1276)

Percent of submissions and TGA responses published on the TGA website in target timeframes.1 Submissions and responses to one consultation were published during the reporting period.

100% 100% 100%

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

9648 647

9169 592

7915 554

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

N/A 75% N/A

1We aim to publish consultation submissions and the TGA response (where appropriate) within two weeks of noting or advice from the Assistant Minister for Health, where applicable.

N/A = Not applicable. This survey is conducted on an annual basis.

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.

109 7 73 6 1024

4237

1157

4558

2805

5905

3184

5061

0

1000

2000

3000

4000

5000

6000

Written Phone Written Phone

Jul - Dec 2014 Jan - Jun 2014

PCT responded withinput

PCT responded

Referral toregulatory areas


Written enquiries include emails, faxes and letters. The graph has been modified from the previous report to better reflect the volume of enquiries managed by the PCT during the reporting period.

There were 1199 voicemail messages received during this period.

The PCT responded to 100% of email and voicemail enquiries within the specified timeframes during the reporting period.

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1.3 Performance against TGA customer service standards

Time taken to respond to complaints Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

Number of complaints received by email Median time taken to respond (days)

0 5 5

6 5

Complaints received by telephone Time taken to respond (days)

0 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.

2. Premarket business operations Jul – Dec 2014

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)

164 (100%) 206 (99.5%) 230 (100%)

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

737 (100%) 754 (100%) 792 (100%)

Non-prescription medicines: new applications1

N1 (target timeframe = 45 working days) 116 (94%) 131 (98%) 97 (80%)

N2 (target timeframe = 75 working days) 8 (100%) 2 (100%)




Non-prescription medicines: change applications1

C1 (target timeframe = 20 working days) 261 (97%) 184 (84%) 248 (92%)

C2 (target timeframe = 64 working days) 134 (99%) 169 (98%) 176 (66%)

C3 (target timeframe = 120 working days) 3 (67%) 6 (100%)

C4 (target timeframe = 170 working days) 02 3 (100%)

Complementary medicines

Registered complementary medicines (mean approval time; working days)

1603 02 N/A

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

239 225 N/A


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

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


2. Premarket business operations Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

Medical devices

Conformity assessments processed within the target timeframe (255 days)

95 (100%) 137 (100%) 87 (100%)

Non-compulsory Application Audits processed within the target timeframe4 (30 working days)

133 (54%)5 478 (38%)6 N/A

Level 1 Application Audits processed within the target timeframe4 (30 working days)

13 (77%) 16 (60%) N/A

Level 2 Application Audits processed within the target timeframe4 (60 working days)

156 (18%)7 205 (60%) N/A

In vitro diagnostic medical devices

Conformity assessments processed within the target timeframe (255 days)

25 (100)% 24 (100%) 15 (100%)

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

8 (50%) 6 (33%) N/A

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

78 (83%) 69 (91%) N/A

1Data for new and change applications were reported differently prior to 2014. The data reported are the total number of applications completed during the reporting period and the percentage that were completed within target timeframes. 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:

· 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 assessment 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 and 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. 2There were no approvals for this application type during the reporting period.

3There were three applications approved, which were different dosage forms of the same product line. Thus, the average time for completion of the three individual applications is divided by 3 for reporting purposes. 4The target timeframe is inclusive of the period of up to 20 working days from when the application is made (application fee paid) during which time the TGA must or may select the application for auditing. 5This figure does not include applications for reclassification of total or partial shoulder, hip, or knee joint replacement devices. These applications are not subject to the agreed target timeframe. 6This figure includes Joint Implant Reclassification applications processed within 30 working days as non-compulsory application audits. There were 225 non-compulsory application audits processed in January to June 2014, of which 32% were completed within the 30 working day target time frame. 7The intricate nature of these audits vary considerably and during this reporting period the majority of audits undertaken were of significant complexity.

N/A = not applicable. These measures were reported for the first time in the January to June 2014 KPI report.


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

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

45

6 7 6 5 10

0

10

20

30

40

50

Jul - Dec 2014 Jan - Jun 2014 Jul - Dec 2013

Num

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following a

complianc

e review

Listed Medicines

Medical Devices


The number of Listed Medicines cancelled in this reporting period is higher than previous periods as a sponsor of 36 products failed to comply within 14 days after the end of the specified period, in a notice requiring information or documents relating to the goods.

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3.2 Medical device incidents 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.

100 100 100 86 82 84

0

20

40

60

80

100

Jul - Dec 2014 Jan - Jun 2014 Jul - Dec 2013

Percentage

of inciden

t reports

Incident reports triaged within 30days

Incident reports closed out within90 days


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3.3 Other postmarket activities Postmarket business operations Jul – Dec

2014 Jan – Jun 2014

Jul – Dec 2013

Regulatory compliance

Outcomes of completed investigations of alleged offences: Warning issued 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

509 42 4 8 0 148

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

2 3 0

Decisions in relation to complaints about advertising of therapeutic goods1

02 11 N/A

Public information on inappropriate unlisted therapeutic goods

18 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% 96% N/A

Class I and II recalls when they are indicative of a safety concern for: · Medicines · Medical devices · Biologicals3 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 biologicals · Medical devices6

100% 98% 04 100% 96% 100%

92% 97% 100% 05 95% 100%

N/A

1This indicator relates to complaints about the advertising of therapeutic goods that are received via the Complaints Resolution Panel. 2In this period, compliance with the advertising requirements was achieved without issuing a formal Regulation 9 Order. 3The target timeframe for initial review of Class I and II recalls is two working days. 4There were no actions relating to recalls for biologicals during the reporting period. 5There were no actions relating to safety issues identified through targeted or random review during the reporting period. 6The target timeframe for risk assessment and triage of safety signals for medicines, biologicals and medical devices is 30 days.

N/A = not applicable. These measures were reported for the first time in the January to June 2014 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

Jul – Dec 2014

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 Nineteen positions were advertised during this period, eight of which were filled before 31 December 20141

5 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 1.0 0.8

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

100% 100% 100%

We keep staff informed through two primary internal communication channels: the TGA Daily and the TGA Weekly2 Percentage of TGA Weekly disseminated (weekly for 24 weeks during this reporting period)3 Percentage of TGA Daily disseminated (five days/week)

100% 100%

100% 100%

100% 100%

1These nineteen positions include positions that were advertised internally within the Department of Health, within the Australian Public Service, and some specialist positions that were open to eligible members of the community. 2Ad hoc messages are also sent directly to staff outside these two channels as the need arises. 3TGA weekly editions are 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. In 2014 the department adopted the Australian Public Service Employee Census as its survey instrument. 2014 data for ‘Staff that agree the work they do is important for the public’ is not available as the question was not included in the census.

65 65 71

59 62 67

55

60

65

70

75

2014 2013 2014 2013

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

Staff that agree that the work they dois important for the public (%)

Percen

t of staff

TGA

APS


*Of the 563 survey respondents in 2014, 23% of TGA staff provided a neutral response to this survey question.

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5. Financial performance TGA’s activities are primarily cost recovered from industry. In addition, TGA has received appropriation funding in 2014-2015 for aligning Australia and New Zealand therapeutic arrangements. The function of administering compliance frameworks for controlled drugs was transferred to the TGA area of the Department of Health in August 2014 and continues to be funded from the departmental appropriation. As a result, TGA now has multiple funding sources for its activities. These activities contribute to Outcome 7 ‘Health infrastructure, regulation, safety and quality’ and Outcome 9 ‘Biosecurity and emergency response’ in the Department of Health Portfolio Budget Statements.

This indicator on our financial performance shows that we are within the target budget range when compared to budget.

5. Financial performance

Total revenue Total expenditure

Time period Actual ($’000)

Budget ($’000)

Variance (%)

Actual ($’000)

Budget ($’000)

Variance (%)

Jul – Dec 2014 (year-to-date)

68,504 70,072 -2% 68,045 70,331 -3%

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%.

Year-to-date revenue is lower than forecast, primarily due to delays in recruitment of qualified inspectors. This has impacted on inspection fee revenue for Good Manufacturing Practice for the first half of the financial year. Inspections have been rescheduled to the second half of the financial year and this will see revenue progressively return to budgeted levels.

Below budget year-to-date expenditure arises from reduced employee expenses, with lower than budget average staffing levels and no change in pay rates from last financial year. It is expected that expenditure will be within the target range at year end.


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6. Statutory obligations 6.1 Performance in addressing audit findings Jul – Dec

2014 Jan – Jun 2014

Jul – Dec 2013

Financial audits

Outcome of the financial audit Unmodified N/A Unmodified

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

100% N/A 100%

Percentage of management responses completed prior to publication of audit report

100% N/A 100%

Performance audits

Percentage of management responses completed prior to publication of audit report

No performance audits

100% No performance audits

N/A = not applicable. Financial audits are undertaken annually, at the end of June.

6.2 Performance in meeting other statutory obligations Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

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

99% 93% 98%

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

100% 100% 100%

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

70% 62% 48%

Percent of compliant regulation impact statements completed by the TGA (three were completed) Percent of compliant cost-recovery impact statements completed by the TGA (six were completed)

100% 100%

N/A 100%

100% 100%

1A 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. 2The 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 a review of Pharmaceutical Inspection Cooperation Scheme (PIC/S) strategies and policies, as the basis for mutual recognition of decisions on Good Manufacturing Practice (GMP) inspections.

Commenced regular sharing of inspections schedules with the United States of America’s Food and Drug Administration (US FDA) and Health Canada, with the view of identifying opportunities for joint inspections.

Conducted six joint GMP inspections with other regulatory agencies, including the European Medicines Agency (EMA), European Union (EU) member state regulators, the US FDA and Health Canada.

A TGA inspector spent one month at Health Canada to establish regular information sharing channels and participate in an inspection of a Canadian manufacturer.

International Medical Devices Regulators Forum (IMDRF)

National Competent Authorities Report Exchange Program: contributed to a draft paper for public consultation following a review of the program.

Regulated Product Submission: agreed on an International standard for the format of Regulated Product Submissions and commenced work on converging Regulated Product Submission definitions with those used within the Universal Device Identification system.

Software as a Medical Device: developed an understanding of Quality Management System issues relating to the development of Software as a Medical Device.

Model for a Medical Devices Single Audit Program (MDSAP): developed an assessment and decision process for the recognition of MDSAP Auditing Organisations.

Pilot Medical Device Single Audit Program:

Participated in Pilot MDSAP In Head Office and Critical Location assessments and “witnessed audits” of medical device manufacturers of candidate Auditing Organisations.

Developed policies, guidelines and quality management documentation for the MDSAP program.

Developed strategies for achieving greater manufacturer participation in MDSAP.

Maintained and enhanced existing Pilot MDSAP Quality System Procedures and Policies

Participated in the development and implementation of an MDSAP information technology portal.


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7.1 Participation in international harmonisation activities

International Generic Drug Regulators Programme (IGDRP)

Participated in the pilot IGDRP-EU Decentralised Procedure for the evaluation of generic medicine applications.

Incorporated the IGDRP evaluation templates for TGA assessment of Biopharmaceutics Classification System-based biowaivers and Active Substance Master Files / Drug Master Files.

Extended the collaboration initiative from a pilot to a programme and agreed to host a website and be the Secretariat for the programme for a period of two years.

International Coalition of Medicines Regulatory Authorities (ICMRA)

As project lead, commenced the development of draft protocols between ICMRA partners in order to promote worksharing, particularly in relation to the pre-market authorisation for generic medicines and data requirements for mutual recognition of GMP inspections.

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.

Further enhanced information sharing processes with Health Canada in the area of premarket assessment of generic medicines as business-as-usual through the routine exchange and utilisation of evaluation reports.

A pharmaceutical chemistry evaluator spent four weeks at Health Canada to continue to build confidence regarding generic medicines evaluations between TGA and Health Canada.

Orphan Medicines

Continued to monitor opportunities to enhance collaboration and information sharing regarding assessment of orphan medicines with other regulators.

Collaborative arrangements

Finalised a new collaborative arrangement with the Singapore Health Sciences Authority that allows for sharing of a broad range of confidential information to support our regulatory functions and underpin future collaborative activities.

Continued to develop collaborative arrangements with Swissmedic and US FDA to enhance collaboration and information sharing, including the exchange of information such as assessment reports on orphan drugs.

Commenced the development of a new information sharing agreement with Medsafe to allow for broad information exchange and increase the potential for regulatory alignment.

Conducted a confidence building activity based on the observation of the designation of European Notified Bodies (commercial 3rd party assessment organisations) by European Competent Authorities (Member State Government Regulators or Government appointed delegates).


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7.2 Collaboration and work-sharing with other regulators Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

Exchange of bioequivalence reports1 and monographs to support generic prescription and non-prescription medicines registration, respectively: Number of monographs developed with Health Canada to support non-prescription medicines registration. We implemented a monograph for topical nasal decongestants, which was previously developed with Canada.

0

0

2

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

1941 1481 2058

Work sharing and single inspections under the Medical Devices Single Audit Program (Pilot MDSAP). As it is still in pilot phase, inspections under the MDSAP are yet to commence.3

N/A N/A N/A

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

1

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 continue to be explored, including Biopharmaceutic Classification System-based biowaivers. 2 Approximately 95-98% of overseas manufacturer clearances are issued via desktop assessments that take into account overseas regulator decisions 3 In January to June 2014, 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.

N/A = not applicable..


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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 Jul – Dec 2014

Jan – Jun 2014

Jul – Dec 2013

Internal review1

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 substituted2 · initial decision remitted · internal review request withdrawn.

18 (100%) 9 (50%) 6 (33%) 2 (11%) 1 (6%)

25 (100%) 15 (56%) 7 (32%) 0 (0%) 3 (12%)

22 (100%) 11 (50%) 8 (36%) 1 (5%) 2 (9%)

External review

Four matters referred by sponsors to the AAT were 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.3

1 (25%)

0 (0%)

0 (0%)

1 The data reported are the number and percentage of decisions subject to internal review. 2 Additional information was provided to the internal review delegate in all six cases where the initial decision was revoked or revoked and substituted. All internal reviews during the reporting period were completed within target (legislated) timeframes.

3 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 R15/100111

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mailto:[email protected]

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

Documents

TGA key performance indicators · Therapeutic Goods Administration TGA key performance indicators As a part of the Department of Health, the TGA safeguards and enhances the health