The TGA conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

We identify and prioritise therapeutic goods for testing to fulfil its regulatory compliance and monitoring requirements, and the transparency and accountability requirements of Government. The testing program also provides flexibility and capacity to provide testing for investigations into problem reports, complaints and urgent public health concerns.

A risk management approach is used, which is consistent with ISO 31000: Risk Management principals and guidelines, to identify products with a higher risk of not complying with the required quality standards. This risk based, targeted approach to testing is reflected in the failure rates reported in the table below.

Laboratory results are made available through the Database of TGA Laboratory Testing Results, Consumers and health professionals can identify which products have been tested by the TGA, whether they passed or failed, and for those that did fail, what regulatory action was taken. Providing this information has been an important enhancement to the transparency of the Government's regulatory processes and the vital role of the TGA in ensuring the safety, efficacy, performance and quality of medicines and medical devices for Australian consumers.