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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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About the Therapeutic Goods Administration

The Australian Government Department of Health, through the Therapeutic Goods Administration (TGA) is responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose.

Products for which therapeutic claims are made are assessed by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added during the reporting period. All therapeutic goods registered on the ARTG can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from retail outlets
  • complementary medicines, such as vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices (IVDs), such as blood tests
  • vaccines, blood products, and other biologics.

We play a regulatory role in overseeing the manufacturing process and advertising of therapeutic goods. We support compliance with the regulatory framework, working with state, territory and federal counterparts to remove unsafe/non-compliant therapeutic goods from the Australian market.

More information about how therapeutic goods are regulated in Australia can be found on our website.

Executive summary

Each year we provide information about our regulatory performance through the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance against the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.

The statistics contained within this report cover the period 1 July 2018 to 30 June 2019, and contribute to annual publications that track our progress against the priorities we have established for the financial year.

Performance highlights

Key observations for 2018-19 are summarised below, including trends and notable changes from previous reporting periods.

As part of our 2018-19 activity, we have continued to implement the Australian Government's Response to the Review of Medicines and Medical Devices Regulation (MMDR). Following the passage of amendments to the Therapeutic Goods Regulations 1990 that follow on from commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 and Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018, this reporting period now includes new data sets in relation to:

  • advertising compliance and enforcement
  • medicine shortages/discontinuations reporting
  • overseas regulator conformity assessment documents for medical devices
  • patient information leaflet and patient implant card for permanently implantable devices
  • work sharing with Comparable Overseas Regulators.

Also, new information about other reforms and programs implemented during this reporting period relate to:

  • autologous human cells and tissues (HCT) therapies
  • laboratory testing.

Reforms

Prescription medicines

  • Consistent with the intent of the MMDR, we also initiated and publicly consulted on possible reforms to the registration process for generic medicines.

Over-the-counter medicines

  • The total number of new medicine applications received was lower than in 2017-18. This was due to a significant decrease in the number of lower risk N1 applications received. There was an increase in the numbers of all other new medicines application categories (N2, N3, N4 and N5).
  • The total number of applications received to vary existing medicines increased substantially, by approximately 25%. The number of negligible risk (CN and C1) applications increased slightly and there was a significant increase in the number of low risk variation (C2) applications. This increase in the number of C2 applications was largely due to receipt of applications for changes to labelling for compliance with the Labelling Order (Therapeutic Goods Order No. 92). The numbers of higher risk variation (C3 and C4) applications were consistent with previous years.
  • Median approval times for the majority of new medicine application categories were longer than in 2017-18, but were consistent with previous years. Median approval times for higher risk variation (C2, C3, and C4) applications were longer than in 2017-18. This increase in median approval times can be attributed to the increase in numbers of N2, N3 and N4 applications and the large increase in the number of C2 applications received.
  • For all application categories, the percentage of applications processed within target time was more than 80%, with many application categories at or close to 100%.

Listed medicines

  • There was an increase in the number of new listed medicines that were entered into the ARTG this year (1,893) compared to last year (1,792).
  • Permitted indications for complementary medicines were introduced in March 2018 following the MMDR review. There were no applications finalised in 2017-18.
  • The new pathway for assessed listed medicines was introduced in March 2018 following recommendation from the MMDR review. There have been no applications received via this pathway as at 30 June 2019.
  • The number of applications for variations under section 9D(1) of the Act has significantly increased this year (from 96 in 2017-18 to 144 in 2018-19). This is likely due to sponsors reviewing a large number of existing entries in anticipation of transitioning to permitted indications.

Work sharing with overseas regulators

  • The Australia-Canada-Singapore-Switzerland (ACSS) Consortium's work sharing pilot on New Chemical Entities is a unique global collaboration between regulatory authorities and the pharmaceutical industry. The ACSS Consortium is a collaborative initiative of medium-sized regulatory authorities between the TGA, Health Canada, Singapore's Health Sciences Authority and the Swiss Agency for Therapeutic Products. Regulators undertake a single assessment for new products that will support regulatory decision-making within each jurisdiction.
  • This partnership is benefiting the community by improving access to the most recent and innovative treatment options. In 2018-19, this initiative has resulted in three new medicines - apalutamide (Erlyand®), abemaciclib (Verzenio®) and niraparib (Zejula®) receiving market approval in Australia and Canada.
  • The ACSS partnership maximises the use of up-to-date technical expertise and brings greater alignment of regulatory approaches, technical requirements, knowledge sharing and better use of resources. While also facilitating cooperation and collaboration, reductions in duplication, and increases each regulators capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

Biologicals

  • Major reforms were introduced to increase the oversight of autologous human cell and tissue, such as stem cell clinics. The number of new and variation applications for biologicals has stabilised. The first Class 4 biological product (CAR-T cells) was approved.

Medicine and vaccine adverse event reports

  • A new Adverse Event Management System was introduced in June 2018. Due to differences in the way adverse event report data is recorded in the new system, the data included in this report is not directly comparable to previous reports.
  • During this period, we received a total of 24,016 medicine and vaccine adverse reaction reports (4,225 reports related to vaccines). The mean number of reports received by the TGA weekly was 462. Of the accepted cases, 62% (13,874) were submitted by pharmaceutical companies and 20% (4,415) were made by health professionals. The most prolific reporters among health professionals were pharmacists (including hospital pharmacists) with 1,918 reports submitted.

Medical device conformity assessment

  • The target timeframes for the processing of conformity assessment applications were met, with continual focus on process improvement. The number of conformity assessment applications received decreased while the number of applications completed was comparable with the same reporting period in 2017-18.

Medical device incident reports

  • The number of medical device adverse event reports increased by 10% in 2018-19 compared to the previous year (5,874 reports). This increase can be attributed to ongoing media and public attention about medical devices, continued education of health professionals on the value of reporting adverse events, and improved sponsor reporting compliance.
  • Class I medical device reviews have increased since the introduction of fees to include these devices on the ARTG. A streamlined internal review process has resulted to ensure that the throughput is minimised.

Medicines and biologicals manufacturing

  • There was a notable increase in the number of overseas inspections being undertaken within six months of manufacturers making application for initial inspections, from 68% in 2017-18 to 86% in 2018-19; and within six months of the due date for re-inspections, from 66% to 85%. This is due to manufacturers being ready for inspection and the prioritisation of these inspections within the target timeframe. The number of both local and overseas manufacturers with an unacceptable compliance rating has reduced. Notably, no inspections of overseas manufacturers completed in this period found manufacturers that had unacceptable compliance.
  • Demand for Good Manufacturing Practice (GMP) clearances remained high with 6,628 applications received, however it is noted that a change in reporting method from 2017-18 now captures additional application types, such as extensions, which were not previously captured.

Recalls

  • Overall, the total number of recall actions remained similar to that of the last financial year.
  • There has been a significant increase (25%) for recall actions performed for in vitro diagnostic devices (IVDs).
  • Medicine consumer level recall actions have increased, from 8 to 13.
  • The new provision in the updated Uniform Recall Procedure for Therapeutic Goods (URPTG) pertaining to 'consumer recall notices' largely negates the previous mandatory requirement for costly print media advertising. This has also allowed for customisation in sponsors' communication to consumers regarding 'open seller products' via social media platforms and utilisation of their own websites, in addition to notices published by the TGA and in some cases the Australian Competition and Consumer Commission (ACCC).

Laboratory testing

  • In 2019 the TGA started the periodic publication of more detailed reports related to specific testing projects. One such report related to a survey of microwaveable grain-filled heat packs to assess the safety and performance of products available on the Australian market. Another report related to testing of a range of human insulin products to compare the quality and content of products obtained directly from sponsors against those available in pharmacies. These reports provide consumers with additional context and detail.

Medicine shortages/discontinuations

  • The Medicine Shortages Information Initiative was established to allow a more transparent and responsive approach to the management of medicine shortages and discontinuations.
  • From 1 January 2019, it has been mandatory for sponsors to report shortages or discontinuations of all prescription medicines and some over the counter medicines to the TGA. This has resulted in a very significant increase in reports.
  • All shortages deemed to be of critical patient impact are published, but sponsors are encouraged to publish information about all shortages on the TGA Medicine Shortages website.
  • The compliance framework in relation to the reporting obligations under the reporting scheme came into effect on 1 July 2019.
  • Where necessary, the TGA can work with sponsors to allow for the import and supply of overseas products to assist with a medicine shortage in Australia under Section 19A of the Therapeutic Goods Act 1989.

Processing and approval times

Processing and approval times are defined as the number of working days from the acceptance of an application until formal notification of decision, unless otherwise specified. These exclude times where we were unable to progress the application due to waiting for:

  • the sponsor to provide additional information;
  • the payment of fees was received; or
  • a 'mutual clock stop' period, agreed with the applicant or unless otherwise specified.

Under the Act, TGA working days also excludes public holidays and weekends. The timeframes applicable to many of our activities are mandated by legislation. For other activities we conduct we self-impose target timeframes, to ensure that we perform our functions efficiently and in a timely manner. Target timeframes are subject to ongoing review.

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