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Performance statistics report: July 2015 to June 2016
The TGA, through the Performance Statistics Report, provides detailed statistical information on our performance to our stakeholders.
This is the first time that we have published the Report in this format and will continue to provide this information annually for each July to June period.
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The TGA provides information on our regulatory performance to our stakeholders through detailed statistical information. The following statistics cover the period 1 July 2015 to 30 June 2016. This is the first report following a review of our reporting framework and the development of the TGA key performance indicators under the Regulator Performance Framework.
The performance statistics provided in this report should be read in conjunction with the Key Performance Indicator Report which outlines performance against our broad strategic intent, as required under the Government's Regulator Performance Framework.
Key observations: July 2015 to June 2016
Key observations for 2015-16 are summarised below, including trends and notable changes from previous reporting periods.
Over the past three years, the number of submissions received across some Category 1 application types has been relatively stable. Applications for new generic medicines and Extension of Indications (EOI) in 2015-16 were comparable to those received in 2013-14, following a slight drop in 2014-15. While New Chemical Entity (NCE) submissions were higher in 2015-16 than in 2014-15, they remained down on the high number received in 2013-14.
All Category 1 submissions processed in 2015-16 were within the legislated 255 working day timeframe with a modest decrease in average approval times for NCE, EOI and generic medicine applications. Median approval times for all application types were lower than previous years, including Additional Trade Name applications which reduced to 35 TGA working days following the introduction of a 45 day legislated timeframe from 1 July 2015.
The total number of new medicine applications received in 2015-16 was lower than in 2014-15, primarily due to a drop in the number of low risk (N1) applications.
The number of applications received to vary existing medicines and median approval times for the majority of application types remained largely consistent with previous periods. There was, however, a significant increase in approval times for N3 (new 'generic' medicine) and C4 (non-quality change) applications, likely influenced by varying application complexity.
The number of new ingredients permitted for use in listed medicines increased, primarily due to finalisation of the Permitted Ingredients List project which resulted in the approval of 10 new ingredients.
Compliance activity for complementary medicines increased during 2015-16. The number of compliance reviews more than doubled, largely the result of business process improvements to streamline the overall review process and improve review timelines. The number of investigations initiated also increased, driven by external factors including complaints and referrals.
Medicines with verified compliance breaches were 80% for 2015-16 compared to 73% for 2014-15, suggesting that the overall rate of non-compliance has remained high despite the significant increase in compliance reviews.
Labelling, advertising and evidence continued to be the major compliance breaches for listed medicines. In 2015-16, 13 products were found to have safety related issues, compared to no products in 2014-15. This increase in 2015-16 was largely a result of targeted work undertaken on safety of ingredients.
During 2015-16 there was a significant increase in applications received for variations to approved biologicals (Class 2). This was the result of transitional arrangements during 2014-15 to reflect new requirements under the regulatory framework for biologicals that commenced in May 2011.
Medicine and vaccine adverse event reports
Overall, adverse events reports in 2015-16 were similar to those in 2014-15. While the number of adverse event reports from pharmacists fell, reflecting a change to pharmacist reporting classifications during reporting periods, adverse event reporting from members of the public increased. This was likely the result of activity to promote adverse event reporting from consumers.
During 2015-16 we received 2,816 medical device applications for inclusion on the Australian Register of Therapeutic Goods (ARTG) (excluding the 2,685 Class I medical devices automatically included). A total of 3,266 applications were completed (including a number on hand at the commencement of the reporting period), with 92% of these approved. Two transition periods - for joint reclassification and commercial In-Vitro Diagnostics (IVDs) - ended on 30 June 2015. While high numbers of applications for these medical devices were received in 2014-15, the end of the transition period has seen an end to these applications.
Processing times for conformity assessment applications for new devices were well within the 200 TGA target days. However, processing times for Level 2 compulsory audits of applications were well above the target 60 TGA working days. Delays were due to a significant wait time for commencement of the clinical assessment component.
Post-market reviews for 83 devices were completed. The drop in activity was largely due to a number of device reviews that required a detailed clinical review.
An increase in the number of device incident reports may have been due to the inSite program (to improve awareness about medical device adverse event reporting) and increased vigilance within the medical community. As figures were collected at a point in time, the apparent disconnect between received and completed reports was likely the result of data crossing annual boundaries.
The IVD regulatory framework transition period for commercial IVDs ended on 30 June 2015. Application numbers for 2014-15 were higher due to extra applications associated with the transition. In 2015-16 application numbers fell, and were more representative of expected ongoing numbers.
Access to unapproved therapeutic goods
There was an increase in the number of Special Access Scheme Category B applications for biologicals in 2015-16, due to an increase in applications by dental practitioners for access to a dental product for bone grafts.
In relation to clinical trials, data for 2015-16 reflects the transition of the Clinical Trials Notification to an online system on 1 July 2015. During the transition process there was a parallel paper-based notification system. In addition, there were some differences between the previous paper-based system and the online form in the capturing and reporting of clinical trial information.
Medicines and biologicals manufacturing
Demand for Good Manufacturing Practice (GMP) clearance increased with 5,657 applications received 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 opportunities for evidence to be used in support of Australian GMP clearance applications. The increase in applications reduced the number of on-site inspections as evidence could be relied upon in lieu of an inspection.
There was an increase in the number of licences revoked at the request of manufacturers. The majority of these were the result of the relocation of services by The Australian Red Cross Blood Service.
There was an increase in the number of recalls for medicines and medical devices that corresponded with an increase in the number of ARTG entries.
There was a significant increase in the number of unregistered products tested. This category of products traditionally has a high rate of failure due to counterfeiting and adulteration. The increase in testing of unregistered products also increased the overall percentage fail rate for all products tested in 2015-16.
Regulatory compliance actions almost doubled in 2015-16 due to an increased number of referrals by the Australian Border Force, increased awareness through publication of safety alerts relating to specific unapproved products, and educational materials including videos about the risk of buying unapproved products online.