By Stewart Eisenhart, Emergo Group
Health ministers of Australia and New Zealand report progress toward launching a joint regulatory body for oversight of medical devices in both countries. Once operational, the new system will replace both the Australian Therapeutic Goods Administration and New Zealand’s Medicines and Medical Devices Safety Authority.
At the second meeting of the Australia New Zealand Therapeutic Products Agency (ANZTPA) Implementation Ministerial Council held in late November, participants unveiled a new website, www.anztpa.org, which provides information to consumers and industry on ANZTPA implementation developments.
Within the next year, Australian and New Zealander regulatory officials plan to establish a common recall portal for medical products, a joint early warning system to inform the public of drug and device safety issues, and a single process for evaluating the safety and efficacy of over-the-counter drugs and devices. The two countries also plan to implement an integrated process for auditing Good Manufacturing Practice; the TGA and MedSafe will begin sharing quality system audit reports to support this effort.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.