Revised: 9 January 2013

Consultations

Description of a possible joint regulatory scheme for therapeutic products under ANZTPA

In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered by the Australia New Zealand Therapeutic Products Agency (ANZTPA). The objective of this project is to develop a responsive and cost-effective regime for jointly regulating therapeutic products in Australia and New Zealand that is consistent with international best practice.

A discussion paper on a possible framework has been released on the Transition to ANZTPA website (http://anztpa.org/consultation/Discussion_paper-ANZTPA_regulatory_scheme-20130107.htm). Submissions are invited to address the key aspects of the framework and the likely impact on stakeholders. Submissions should be received by 21 February 2013.

This is the start of a conversation with stakeholders and Medsafe and the TGA will continue to engage with stakeholders over the coming months as, subject to final decisions of both governments, we work to finalise draft legislation and develop the detail of the regulatory scheme and its associated business processes.

The ANZTPA project creates a unique opportunity to shape the thinking around the design and operation of the new regulatory scheme and a new regulator. In doing so, we want to draw on the strengths of our current regulatory approaches and learn what we can and should do differently and better.

I encourage you and your organisation to consider the outlined proposals and to provide comments and input to guide the future development of a regulatory scheme under ANZTPA that will benefit consumers, industry, health professionals and governments in both Australia and New Zealand.

If you have any question please do not hesitate to contact the ANZTPA Project team at anztpa.info@anztpa.org