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TGA key performance indicators: January to June 2015
Version 1.0, August 2015
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
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.
3.3 Other post-market activities
|Post-market business operations||Jan - Jun 2015||Jul - Dec 2014||Jan - Jun 2014|
|Outcomes of completed investigations of alleged offences:|
|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:|
|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:|
- This indicator relates to complaints about the advertising of therapeutic goods that are received via the Complaints Resolution Panel.
- In this period, compliance with the advertising requirements was achieved without issuing a formal Regulation 9 Order.
- The target timeframe for initial review of Class I and II recalls is two working days.
- There were no actions relating to recalls for biologicals during the reporting period.
- There were no actions relating to safety issues identified through targeted or random review during the reporting period.
- The target timeframe for risk assessment and triage of safety signals for medicines, biologicals and medical devices is 30 days.