The Governments of Australia and New Zealand are joining forces to regulate (approve and manufacture) “therapeutic products (medicines, medical devices, biological and others) to be administered by the Australia New Zealand Therapeutic Products Agency (ANZTPA)”. They have released an information paper outlines a high level description of a possible joint regulatory scheme for therapeutic products under ANZTPA, which can be found here. This document was released on January 8th, 2013, and comments can be submitted until February 21st, 2013. Regulations should be in place for a July 1st, 2016 start date for the new regulations.
The governments hope to achieve a scheme that:
• is responsive and cost-effective
• applies a level of regulation that is commensurate with the potential risks to public health and safety posed by therapeutic products
• balances these risks and the potential benefits to be obtained by users from the availability of these products in Australia and New Zealand
• ensures consumers and health professionals have sufficient, accurate information to enable them to select and use therapeutic products safely and effectively
• assists New Zealand and Australian states and territories to adopt a uniform approach to controlling consumer access to therapeutic products
• as far as possible, harmonises requirements with overseas regulators of equivalent standard.
The regulatory agencies are soliciting:
- 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). If possible, please attempt to quantify these costs and benefits.
- Are there any areas where early harmonisation of processes between TGA and Medsafe would assist your business? Please list details of potential benefits for your business?