Publishing outcomes of listing compliance reviews

Complementary medicines reforms

26 July 2012

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. Apart from certain cancellations of complementary medicines resulting from post-market reviews, the TGA does not currently publish the outcomes of post-market reviews.

A project has been established to deliver improved transparency regarding the post-market review of listed complementary medicines.

Work to be conducted

The improved transparency will be achieved by making information about the post-market review of listed complementary medicines available to the Australian public in a timely manner.

The TGA is therefore working to develop the necessary processes to support publishing outcomes of reviews on the TGA website on a regular basis.

Timetable

See: Reform timeframe and progress

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

This project will address the third 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.