Using risk profiles in listing compliance reviews

Currently, listed complementary medicines can be included on the Australian Register of Therapeutic Goods (ARTG) via the Electronic Listing Facility (ELF) with no pre-market regulatory oversight by the TGA, provided that certain conditions are met - this ensures market access as soon as possible. Rather than conducting pre-market assessment, the TGA assures the safety of listed complementary medicines through a program of random and targeted post-marketing reviews of a proportion of listed complementary medicines. Post-market reviews ensure that listed complementary medicines comply with applicable regulatory standards and requirements, including manufacturing in accordance with Good Manufacturing Practice. Where a post-market review identifies compliance issues, the complementary medicine may be cancelled from the ARTG.

The TGA currently uses random selections and information from external sources (e.g. suspected adverse reactions, market place surveillance) to identify listed complementary medicines for post-market review. As part of the reforms to complementary medicines, a project has been established to:

• capture information at the point of a post-market review about sponsors, listed complementary medicines and issues of non-compliance with regulatory standards and requirements
• use the information collected from post-market reviews to identify trends and develop risk profiles
• use the risk profiles to better inform its post-market review process.

Risk profiles will be developed as information is collected. This will enhance post-market monitoring and more efficiently focus post-market resources towards emerging risk areas.

Work to be conducted

The TGA will make improvements to the handling and collection of post-market review data.

The TGA will engage respected professional expertise to advise on the development of risk profiles. This expertise will require experience in developing and implementing risk profiles for other government regulatory agencies.

Timetable

See: Reform timeframe and progress

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines

This project will address the fourth recommendation of the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines.

Contact

For further information about the Complementary Medicines Regulatory Reforms, contact the Complementary Medicines Branch.