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 new Agency will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and be accountable to the Australian and New Zealand Governments. It will be recognised in law in both Australia and New Zealand and assume responsibility for the regulatory functions currently undertaken in both countries.
The regulatory activities of the agency will include:
- pre-market evaluation and assessment
- product licensing
- controls on manufacture
- post-market monitoring and surveillance; and
- setting standards
The ANZTPA Project team have now released a discussion paper describing the contents of a possible regulatory scheme for therapeutic products in Australia and New Zealand to be administered by ANZTPA. The document was released for consultation on 8 January 2013.
The discussion paper describes the proposed regulatory scheme, based on the draft Rules developed for consultation in 2006 prior to the 2007 postponement of the previous Australian-New Zealand negotiations. The scheme now includes sunscreens, biologicals and in vitro diagnostic (IVD) products within its scope. The regulatory scheme will be further refined and settled after the consultation process. The final scheme will incorporate more recent regulatory reforms, including those outlined in the TGA Blueprint, such as those related to regulation of medical devices and complementary medicines.
TGA and Medsafe are inviting participation in the discussion of the possible framework for regulation of therapeutic products under the joint agency. Submissions are invited to address the key aspects of the framework and the likely impact on stakeholders. Interested parties should respond by close of business 21 February 2013.