Annual performance statistics report: July 2016 to June 2017

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12 September 2017
cover of report

Executive summary

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

The following statistics cover the period 1 July 2016 to 30 June 2017 and contribute to our suite of performance reports.

Performance highlights: July 2016 to June 2017

Key observations for 2016-17 are summarised below, including trends and notable changes from previous reporting periods.

Prescription medicines

Since the 2015-16 report, the number of submissions received across some Category 1 application types varied significantly. While the number of New Chemical Entity submissions remained constant, the number of Extension of Indication submissions increased noticeably and the number of generic medicine submissions greatly decreased. All Category 1 submissions processed in 2016-17 were within the legislated 255 working day timeframe and, on average, were decided in 220 working days or less.

Over-the-Counter medicines

The total number of new medicine applications received in 2016-17 was slightly higher than in 2015 16 with an increase in the number of low risk (N1) and medium risk (N3) applications. In the higher risk (N4 and N5) categories, applications received in 2016-17 were roughly half that received in 2015 16. The total number of applications received to vary existing medicines decreased substantially compared with 2015-16, mostly due to a decrease in the number of low risk (C1) applications. The number of higher risk variation (C2, C3 and C4) applications was consistent with previous periods.

While median approval times for new medicine applications in 2016-17 were longer by approximately 2 weeks compared with 2015-16, the percentage of applications processed within target time continued to be at, or very close to 100%. The longer median approval times can be attributed to the increase in the number of lower risk and medium risk applications as well as varying level of complexity of higher risk applications.

Complementary medicines

The number of new ingredients approved for use in listed medicines significantly increased to 79 in 2016-17 compared with 18 in 2015-16, primarily due to a number of excipient ingredients with limited availability being added to the Therapeutic Goods (Permissible Ingredients) Determination under section 26BB of the Therapeutic Goods Act 1989.

The number of post market compliance reviews completed has remained similar with 10% more reviews completed in 2016-17 than in 2015-16. Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, increased in 2016-17 compared with 2015-16. Investigations are assessed using a risk prioritisation system and where required, will result in a compliance review being initiated.

The rate of verified compliance breaches has remained similar; 79% in 2016-17 compared with 80% in 2015-16. This suggests that the significant increase in the number of compliance reviews in recent years has not driven any improvement in compliance rates. The proportion of medicines found to be non-compliant for which breaches included 'insufficient evidence being held by the sponsor to support the medicine indication' was similar; 54% in 2016-17 compared with 64% in 2015-16.

Labelling, advertising and evidence continued to be major compliance breaches for listed medicines. In 2016-17, 22 products were found to have safety related issues, compared with 13 products in 2015-16. This increase was largely a result of continued targeted work undertaken on reviewing the safety of ingredients.

The number of approved new registered complementary medicines increased to 10 in 2016-17 compared with 3 in 2015-16. The total number of variations completed in 2016-17 decreased to 24 compared with 30 in 2015-16.

Biologicals

The number of new and variation applications stabilised following the transition of most biologicals into the new biologicals regulatory framework during 2014-15. The number of Technical Master File variations increased due to work by the public cord blood banks.

Medicine and vaccine adverse event reports

Overall, adverse event reporting increased from 17,633 medicine and vaccine adverse event notifications in 2015-16 to 19,736 in 2016-17. In particular, the increased number of vaccine Adverse Event Reports may reflect recent additions to the National Immunisation Program in 2016. Adverse event reporting from members of the public also increased which is likely to be the result of activity to promote consumer adverse event reporting.

Medical device incident reports

An increase in incident reports in 2016-17 resulted from media attention, sponsor training workshops in 2016 to increase awareness, and expansion of the Insite program.

Medical devices

There was a significant increase in the number of Level 2 compulsory audits of applications for inclusion of Class III and Active Implantable Medical Devices on the ARTG, which include the assessment of clinical evidence, completed in 2016-17 (471) compared with 2015-16 (205). We refined our processes for clinical evidence assessment in relation to audits and built the capability of our assessment teams to improve assessment timeframes for new medical devices. Concurrent assessments by staff with differing expertise, triage of applications and better application of the risk based approach to assessment of evidence for different categories of devices resulted in reduced waiting times for commencement of the audits of applications seeking pre-market authorisation from 8-9 months to about one month. By the end of the reporting period this significantly increased the completion rate of assessments and improved patients' access to new medical devices.

Exports

The number of new export medicine listing applications and variations remained constant over the last two years. The number of export certificates for medicines dropped in 2016-17 by 25%, however there was an increase in the number of device certificates issued. All medicine certificates were issued within the target timeframe of 15 days. Over 80% of device certificates and new listings and variations were also completed within the target timeframe.

All human blood and tissue permits were released within the 24 hour target timeframe to ensure that emergency demands overseas were met.

Access to unapproved therapeutic goods

The number of notifications and applications for most Special Access Scheme (SAS) categories increased since 2015-16, especially Category A for both medicines and devices. An exception is SAS Category B for biologicals as higher volume products previously accessed through SAS are now on the ARTG.

Medicines and biologicals manufacturing

Demand for Good Manufacturing Practice (GMP) clearances continued to increase with 6,506 applications received during 2016-17 compared with 5,657 in 2015-16. Major contributing factors included sponsors sourcing more products from new and multiple manufacturers, globalisation and company mergers, and overseas regulatory agencies undertaking more inspections in other countries, creating more evidence to be used in support of Australian GMP clearance applications.

Recalls

There was a significant decrease in the number of medicine recalls from 57 in 2015-16 to 32 in 2016-17, and a slight decrease from 611 in 2015-16 to 598 in 2016-17 in the number of medical device recalls.

Laboratory testing

Over the past four years there has been a continued increase in the failure rate of products tested by the TGA Laboratories on a contract basis for external agencies such as the World Health Organization (WHO) and other governments within the region. This increase was again observed in 2016-17. These results highlight the important role we play in supporting other governments to identify sub-standard, degraded or adulterated medicines supplied for use in other countries, and helping to ensure continued health security for the region, including Australia.

Regulatory compliance

Investigations increased by 64% in 2016-17, with 2,887 completed compared with 1,760 in 2015-16. The largest contributor to investigations continues to be referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.

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