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Publishing results of listed medicine compliance reviews
27 November 2019
From December 2019, the TGA will publish the results of all our compliance reviews relating to safety and efficacy of listed medicines on the TGA website. Making information publicly available, particularly that related to efficacy and safety will assist consumers to make informed choices regarding the appropriateness of listed medicines for them.
Background
Listed medicines are included on the Australian Register of Therapeutic Goods (ARTG) without undergoing any pre-market evaluation by TGA. This relies on the medicine satisfying certain criteria for low risk medicines and certifications by the sponsor that their medicine meets all of the requirements of section 26A of the Therapeutic Goods Act 1989.
The TGA conducts post-market compliance reviews of selected listed medicines on the ARTG to determine whether these medicines comply with relevant regulatory requirements. During review, if a medicine is found to not comply with requirements, action is taken by the TGA according to the risk posed by the medicine to the consumer. For example, the TGA may require that the sponsor updates the medicine's label, or the TGA may remove it from the ARTG so that it can no longer be lawfully supplied to the consumer.
The following information is currently published about listed medicine compliance reviews:
- Details of medicines that have been cancelled by the TGA from the ARTG following a compliance review - refer to Complementary medicines: Cancellations from the ARTG.
- Yearly statistics on compliance review activity undertaken, including information about the number and types of reviews and outcomes.
To expand on this information, the Government accepted Recommendation 49 of the Medicines and Medical Devices Regulation (MMDR) expert review that information resulting from compliance reviews, especially that which is related to safety and efficacy of products, is made publically available to consumers.
Database of listed medicine compliance review results
The TGA has launched the Database of listed medicine compliance review results where compliance review results will be published publicly from December 2019.
The searchable database provides consumers and healthcare professionals with information to make informed choices regarding the appropriateness of listed medicines for their situation. The database includes specific consumer advice including whether a medicine can continue to be used safely as directed, the recommended actions for consumers to take in relation to the medicine, and the TGA's findings relating to the safety and efficacy (that the medicine does what it says it will do) of the medicine.
Extensive consultation on this reform was conducted with consumer, industry and healthcare professional representatives. Making compliance review results publically available, particularly in relation to the safety and efficacy of the medicines, was seen as an important initiative by representatives from both consumer and healthcare professional bodies that were consulted during development of the database. This information could help consumers make informed choices regarding the appropriateness of listed medicines for their situation, and provide confidence about whether a listed medicine is safe and does what it says it will do. Health professionals also advised that timely and accurate information would assist them in providing support and advice to patients.
How will the publication of listed medicine compliance review results work?
For consumers
- The results of listed medicine compliance reviews will be published quarterly.
- The compliance review results database does not provide safety alerts as issues arise. Urgent safety messages will continue to be published on the safety alerts web page.
- Less significant non-compliance issues that do not related to the safety or efficacy of the medicine, such as those of an administrative nature, will not be detailed in this publication.
- Further information to help with understanding the published results is provided on the database page.
For sponsors of listed medicines
- Listed medicine compliance reviews that are currently in progress will be subject to publication. Further information will be provided in letters to each sponsor during the compliance review, before publication of review results.
- Sponsors of listed medicines that are reviewed will have an opportunity to make a submission to the TGA about the results that are proposed to be published about their medicine. This submission will be considered prior to publishing the results of the compliance review.
- Results will only be published following the conclusion of the compliance review (see listed medicine compliance reviews).
More information
For more information on how listed medicines are regulated in Australia please see:
For information on the listed medicine compliance review process or compliance and enforcement please see:
Contact
For further information about the Complementary Medicines Regulatory Reforms, contact the Complementary Medicines Branch.