The TGA provides information on our regulatory performance to our stakeholders through the reports against the TGA key performance indicators and measures: Regulator Performance Framework. In addition to reporting against the Regulator Performance Framework, we will also publish our Key Performance Statistics, which provide detailed statistical information relating to the TGA’s performance. As the Regulator Performance Framework came into effect on 1 July 2015, the first report will be published after the close of the 2015-16 financial year.

The statistics provided in this half yearly performance snapshot cover the period 1 July to 31 December 2015. They provide an update on our progress for the past six months and will feed into the annual Key Performance Statistics report.

Prescription medicines
?The number of Category 11 and Category 32 submissions received remained relatively consistent with previous periods.
?Mean processing times for Category 1 and 3 applications were well below the statutory timeframes of 255 days and 45 days respectively.

Over-the-Counter medicines
?The number of new applications (N3 to N5) approved during July-December 2015 increased compared to January-June 2015, but was within the variability of previous periods over 2013-2015.
?There was a large increase in the number of applications to make quality and non-quality related changes to existing medicines at the C1 application level. This is reflective of mandatory warning/cautionary labelling statements that were introduced during this period.
?There was also an increase in the number of applications to make quality and non-quality related changes to existing medicines at the C2 application level. The number of applications to make changes at the C3 and C4 levels remained consistent with previous periods.
?Mean processing times for all types of applications were below the agreed target timeframes. The percentage of applications completed within target timeframes was consistently higher than the 80% target.

Complementary medicines
?The number of newly listed and registered complementary medicines entered on the ARTG is similar to the number of new entries reported in previous reporting periods.
?There was a large increase in the number of new ingredients permitted for use in listed medicines. However, this was the result of TGA initiated assessments of 10 new ingredients.
?The number of compliance reviews initiated increased significantly in the July-December 2015 period. This is largely the result of numerous business process improvement strategies that have been implemented to streamline the overall review process and improve review timeframes.
?Medicines with verified compliance breaches were 72% for the July-December 2015 period, compared with 78% for July-December 2014 and 65.5% for January-June 2015. This is for a combination of both targeted and random reviews. This suggests that the overall rate of non-compliance has remained unchanged despite the significant increase in the number of compliance reviews.
?A significant proportion of listed medicines reviews are concluded after the sponsor has adequately addressed the identified compliance breaches. This demonstrates that industry is willing to work with the TGA to ensure the supply of compliant medicines on the ARTG.

Medical devices
?The transition periods for the up-classification of joint replacement implants and the new IVD regulatory framework both finished on 30 June 2015. The end of these transition periods resulted in increased numbers of applications received in June 2015. Assessment of these additional applications has continued throughout the July to December 2015 period. Once these applications have been assessed it is expected that ongoing applications for these kinds of devices (joint replacements and IVDs) will settle to a more sustainable ongoing trend.

Medicine and vaccine adverse event reports
?Several workshops have been provided to the pharmaceutical industry this year - in conjunction with ARCS Australia - on effective risk minimisation activities to improve the quality of the Risk Management Plans (RMPs).
?We have obtained access to datasets from the Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) to assist with post-market monitoring. The first data linkage exercise with MBS and PBS data has been completed and is currently being analysed.

Regulatory compliance
?There was a significant increase in the number of goods released to importers under the Personal Importation Scheme in the July-December 2015 period compared to previous periods. On the release of these goods, information was provided regarding obligations of importers utilising the Personal Importation Scheme to assist in future compliance.
?Challenges that impacted on performance for this period included an increase in the number of alleged offences reported and significant staff turnover.

Scientific evaluation
?The biologicals regulatory framework commenced in 2011 to regulate human cell and tissue-based products. For products that were supplied prior to commencement, a three year transition period was available to allow lodgement of applications to move to the new framework. In November the transition of all the biologicals supplied by the domestic ‘not for profit’ tissue banks was completed.

Clinical trials
?On 1 July 2015, a new online form was made available under the Clinical Trial Notifications (CTN) Scheme. This is the first in a series of developments to improve and streamline the administrative processes for the scheme, and has been well received by stakeholders. Workshops have also been undertaken to educate and inform stakeholders, and work continues to improve system functionality for the new system.

Laboratories
?During the period between July and December 2015, a total of 4.7 million doses of 43 different vaccine products were released in 260 shipments.

Licencing and Manufacturing
?As at 31 December 2015, there were 255 companies holding 400 Australian manufacturing licences covering 445 sites; and 354 overseas companies holding 414 manufacturer certificates covering 440 manufacturing sites.

Recalls
?Initial review of the 97.5% of the safety related recalls (i.e. Class I and II) actions for medical devices, medicines and biologicals managed during the reporting period was undertaken within the target timeframe of 2 working days from the date of notification. This is in comparison with 95.1% during January to June 2015 and 97.2% during July to December 2014.

Processing and approval times

Processing and approval times are defined as the number of working days from the acceptance of the application until formal notification of decision, unless otherwise specified. Under the Therapeutic Goods Regulations 1990, TGA working days exclude public holidays and weekends. These exclude time where the TGA was unable to progress the application until the sponsor provided additional information or payment of fees, unless otherwise specified.

1Category 1: submissions to register new prescription medicines, or to make significant variations to an existing prescription medicine

2Category 3: variations to existing medicines that do not need to be supported by clinical, non-clinical or bioequivalence data

https://www.tga.gov.au/publication/half-yearly-performance-report-snapshot-july-december-2015