Comment invited on Trans-Tasman regulatory body proposal

A proposal to combine the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) into a single agency accountable to both the Australian and New Zealand governments has been released as a discussion paper.

Trish Worth, Parliamentary Secretary to the Australian Minister for Health and Ageing, said that the discussion paper had been developed after consultation with stakeholders in Australia and New Zealand, and was now being made available for public consultation and comment.

"A joint agency would certainly promote closer economic relations with New Zealand, reduce trade barriers and assist the medicines and medical device industries on both sides of the Tasman," Worth said in a statement.

"It would provide a one-stop-shop for companies to gain approval to enter both markets with common product labelling and standards."

According to the discussion paper, A Proposal for a Trans-Tasman Agency to Regulate Therapeutic Products, the joint agency would be responsible for therapeutic products including prescription and over-the-counter drugs, medical devices and products regulated as complementary medicines in Australia and as dietary supplements in New Zealand.

Its regulatory activities would include pre-market assessment and evaluation, including clinical trials, product and manufacturer licensing, post-market monitoring, and setting of standards, as well as the communication of decisions and information. Officials from the Joint Agency Project expects that final proposals will go to the Australian and New Zealand governments in late 2002. If accepted, the earliest date for commencement of operation of a new joint agency would be mid to late 2004, as new legislation would be required in both countries.

The discussion paper is available here.