Australia New Zealand Therapeutic Products Authority Project - Consultation continues on the proposed trans-Tasman regulatory scheme for therapeutic products

Australia New Zealand Therapeutic Products Authority Project
Consultation continues on the proposed trans-Tasman regulatory scheme for therapeutic products

18 October 2006

A second phase of consultation on the proposed trans-Tasman regulatory scheme for therapeutic products is now underway and feedback is being invited.

New Zealand is working with Australia to set up a world-class joint regulatory scheme for complementary medicines, over-the-counter and prescription medicines, medical devices, blood and blood products and tissues and cellular therapies.

The aim is to develop a regulatory scheme that better protects the health and safety of consumers who use therapeutic products in both countries.

It’s proposed that a new agency, the Australia New Zealand Therapeutic Products Authority (ANZTPA), would be established to regulate the quality, safety and effectiveness or performance of therapeutic products both before and after they enter the marketplace.

As part of the development of the scheme, submissions are now being invited on technical details of the proposed joint regulatory scheme for:

The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule
The proposed regulation of Blood under ANZTPA
The proposed Product Vigilance arrangements under ANZTPA

Further information about these consultation documents, along with copies of the documents and information about making a submission is available on the ANZTPA website.)

Related links

Submissions sought on proposed Australia New Zealand Therapeutic Products Authority regulatory scheme (May 2006)

Consultation programme released for the establishment of the Australia New Zealand Therapeutic Products Authority (March 2006)

ANZTPA home page