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Publication of TGA laboratory testing outcomes

7 February 2017

From mid-2017 the Therapeutic Goods Administration (TGA) will begin publishing additional information about our laboratory activities, including outcomes of laboratory testing, on the TGA website.

The TGA tests approximately 2000 samples of therapeutic goods annually. While many products tested by us meet required quality standards, we currently provide very little information to the Australian public about the testing activities undertaken by us.

The Expert Review of Medicines and Medical Devices Regulation reports were released in 2015, and the Government's response in September 2016.

This review recommended the Government develop a more comprehensive post-market monitoring scheme for medicines, medical devices, and listed medicinal products including complementary medicinal products.

Part of our response to this report is to publish more information about laboratory activities, including outcomes of laboratory testing, on the TGA website.

This complements our current publication of TGA Business Plans and Performance Reports, and will align the TGA with other key regulators who publish similar information such as the U.S. Food and Drug Administration and European Medicines Agency.

Note: Publication of laboratory test results will NOT replace current mechanisms for providing timely alerts to healthcare professionals and consumers where a serious safety or quality issue has been identified. We will continue to release timely information about safety concerns on our Safety Information website pages including:

  • early warnings
  • safety alerts
  • product recalls
  • adverse event notifications
  • general educational material about safety of medicines and medical devices

What will be published?

The publication of testing outcomes will include basic information such as:

  • product name
  • ARTG number
  • sponsor
  • reason for testing
  • overall testing result (pass/fail)

Where products fail any aspect of testing, the details of the test(s) which failed and the outcome of any follow-up action taken as a result will also be provided.

We will update the TGA website with additional information about the testing program to provide context for the published testing outcomes. This update will include:

  • details of the different kinds of testing we perform
  • information about batch release of biological medicines
  • what happens when products fail laboratory tests

Occasionally we may also publish more detailed reports related to specific testing projects. These reports will include the details noted above as well as additional information such as:

  • background information about the products tested
  • why they were selected for testing
  • the significance of any non-complying test results
  • in some cases, where the reason for testing is to survey a range of products made by specific manufacturer(s), the manufacturer(s) of the products tested

We will not release testing outcomes that are related to ongoing investigations or other compliance actions.

When will this be published?

Laboratory testing outcomes will be published every May and November. There will also be a minimum 6 month delay between testing and publication of results. For example, outcomes for testing completed in the period May-October 2016 will be published in May 2017, results for testing completed in the period November 2016–April 2017 will be published in November 2017. This delay in publication is necessary to allow the TGA to undertake any investigations and follow-up action in response to non-complying test results.