Trans Tasman joint therapeutic products scheme progresses

Progress towards a joint Australia New Zealand therapeutic products regulatory scheme continues with Ministers from both countries attended the second meeting of the Australia New Zealand Therapeutic Products Agency (ANZTPA) Implementation Ministerial Council last week.

The meeting, chaired by New Zealand Health Minister, the Hon Tony Ryall MP, discussed progress to date on the key elements to establish a joint Trans-Tasman therapeutic products scheme and regulator. Also attending the meeting were the Hon Catherine King MP, Parliamentary Secretary for Health and Ageing; the Hon Craig Foss MP, New Zealand Minister of Commerce; and the Hon Bernie Ripoll MP, Australian Parliamentary Secretary to the Treasurer.

Ministers at the meeting announced the launch of a single entry point on ANZTPA for business and consumers, www.anztpa.org. This is a web site that will provide a single source of information on progress on the implementation of ANZTPA, as well as a home for publicly available information developed under the auspices of ANZTPA.

The single entry point website also contains access to a Business to Business project that enables the public to search a single joint database containing information on adverse reactions to medicines. This builds on the publicly available separate databases New Zealand and Australia successfully launched in mid-2012 containing advice on adverse reactions to medicines, providing enhanced access to safety information and improved transparency.

Ministers also noted progress on work currently being undertaken through Australia’s TGA and Medsafe in New Zealand including the commencement of joint working groups to help progress development of a common regulatory framework for the application, assessment and approval of therapeutic products in Australia and New Zealand.

Ministers were pleased to note that an information / discussion paper is planned for release to Australian and New Zealand consumers and industry and other stakeholders in coming weeks. This paper will set out a high level option for a possible framework for the joint regulatory scheme with input invited from interested parties.

Ministers noted that work has progressed on the other Business to Business projects approved at the January 2012 meeting. Within the current financial year the TGA and Medsafe will deliver:

• a common recalls portal for therapeutic products.
• a common early warning system to inform the public of potential safety issues concerning therapeutic products.
• a common streamlined, but rigorous process to evaluate and assess the safety, quality and efficacy of over the counter medicines. This has been aided by workshops already held in Sydney, Melbourne and Wellington and the release of a consultation paper in September 2012.
• an integrated capability to conduct audits to assess good manufacturing practice (GMP). To this end, in early 2013, both organisations will commence sharing of GMP reports.

ANZTPA will be a joint, trans-Tasman scheme and agency with responsibility for regulating therapeutic products across both countries. When established, it will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).