You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

TGA key performance indicators: January to June 2015

Version 1.0, August 2015

3 September 2015

Book pagination

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 2 Cancellations by the TGA of products following a compliance review

Chart showing the cancellations by the TGA of products following a compliance review: Jan-Jun 2015 - 7 listed medicines and 7 medical devices; Jul-Dec 2014 - 45 listed medicines and 6 medical devices; Jan-Jun 2015 - 6 listed medicines and 5 medical devices

The number of listed medcines cancelled in the July-December 2014 reporting period is higher than comparative periods due to a single sponsor of 36 products failing to comply with a notice requiring information about the goods.

3.2 Medical device incidents

Figure 3 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.

Chart showing the triage and investigation of medical device incidents: Jan-Jun 2015 - 100 within 30 days and 85 within 90 days; Jul-Dec 2014 - 100 within 30 days and 86 within 90 days; Jan-Jun 2015 - 100 within 30 days and 82 within 90 days

3.3 Other post-market activities

3.3 Post-market business operations
Post-market business operations Jan - Jun 2015 Jul - Dec 2014 Jan - Jun 2014
Regulatory compliance
Outcomes of completed investigations of alleged offences:      
Warning issued 399 509 371
Goods released under Personal Import Scheme 46 42 33
Referred to another part of TGA 3 4 8
Referred to another department or agency 4 8 8
Import treated as abandoned goods by Customs 0 0 0
No offence detected 59 148 100
Cases of deliberate non-compliance referred to the Commonwealth Director of Public Prosecutions for criminal prosecution 1 2 3
Decisions in relation to complaints about advertising of therapeutic goods1 02 02 11
Public information on unlisted therapeutic goods 26 18 40
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 95% 96% 96%
Class I and II recalls when they are indicative of a safety concern for3:      
  • Medicines
95% 100% 92%
  • Medical devices
95% 98% 97%
  • Biologicals
04 04 100%
Non-compliance of listed medicines, where a safety issue has been identified through targeted or random review 05 100% 05
Safety signals identified through adverse event reporting and other surveillance activities for6:
  • Medicines and biologicals
100% 96% 95%
  • Medical devices
100% 100% 100%
  1. This indicator relates to complaints about the advertising of therapeutic goods that are received via the Complaints Resolution Panel.
  2. In this period, compliance with the advertising requirements was achieved without issuing a formal Regulation 9 Order.
  3. The target timeframe for initial review of Class I and II recalls is two working days.
  4. There were no actions relating to recalls for biologicals during the reporting period.
  5. There were no actions relating to safety issues identified through targeted or random review during the reporting period.
  6. The target timeframe for risk assessment and triage of safety signals for medicines, biologicals and medical devices is 30 days.

Book pagination