Australia, New Zealand End Plans for Joint Regulatory Agency

Australia and New Zealand have abandoned plans for a joint drug regulatory agency, although both countries say they will continue to cooperate on regulations that are mutually beneficial.

The unexpected announcement followed a comprehensive review of the proposal that found creating the Australia New Zealand Therapeutic Products Agency (ANZTPA) would result in inadequate cost benefits for each country, officials from both countries said.

Respective interests are best served by separate therapeutic regimes, New Zealand’s Health Minister Jonathan Coleman said. The new body, proposed in 2011, would have replaced Australia’s Therapeutics Goods Agency and New Zealand’s Medicines and Medical Devices Safety Authority.

The agencies said they will continue to explore regulatory harmonization, including through a new information sharing agreement and formalizing mutual recognition of GMP audits. These efforts would increase the potential to reduce compliance costs, said Coleman.

A New Zealand trade group representing OTC product manufacturers, distributors and marketers was disappointed with the news. Having different regulatory interpretations in each market is a challenge and adds to costs and delays in bringing products to market, said Tim Roper, executive director of the New Zealand Self-Medication Industry Association.

In a separate announcement, Coleman said Medsafe will undergo an upgrade, including the development of a comprehensive regulatory scheme. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.