ANZTPA discussion paper released for comment

The Australia New Zealand Therapeutic Products Agency (ANZTPA) has released a discussion paper to help direct future work on the development of the joint regulatory agency framework to replace Australia's Therapeutic Goods Administration (TGA)and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

ANZTPA will be a joint, trans-Tasman scheme and agency with responsibility for regulating therapeutic products across both countries.

Through the consultation process, the TGA and Medsafe are requesting comment that will help to inform the development of the regulatory framework for ANZTPA.

Submissions may address any, or all, of the proposed amendments to the Description of a possible joint regulatory scheme for therapeutic products under ANZTPA or other identified issues. Submissions might include:

• Suggested improvements;
• Whether or not you support the possible framework. If you do not support the possible framework as described, you may make suggestions for an alternative acceptable to you;
• An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial);
• Any areas where early harmonisation of processes between TGA and Medsafe would assist your business? Please list details of potential benefits for your business?

The discussion paper can be found at the ANZTPA website. And the full details of the consultation process can be found at the ANZTPA: Description of a possible joint regulatory scheme page.

Responses are invited directly by close of business 21 February 2013. AusBiotech members wishing to contribute to the AusBiotech submission, are invited to direct comments to be included to Alina Tooley, National Manager Programs by email or +61 3 9828 1425 by 15 February 2013