Regulatory Focus™ > News Articles > Merger of Australian, New Zealand Regulatory Agencies on Track, Officials Say

Merger of Australian, New Zealand Regulatory Agencies on Track, Officials Say

Posted 29 November 2012 | By Alexander Gaffney, RAC

The planned merger of the regulatory authorities of Australia and New Zealand continues according to plan, both agencies said in an announcement on 29 November 2012.

Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (MedSafe) have been planning for more than a year to merge the two agencies into a regional regulatory authority named the Australia New Zealand Therapeutic Products Agency (ANZTPA).

In a statement in January 2012, the agencies said their objective is to "[Ensure] that consumers have access to safe, quality medicines and medical devices which are brought to market through a single approval process for both countries."

By joining together, they will able to assess products more rigorously, they claimed.

But that merger doesn't happen in a day. Rather, it's an ongoing process that has been seen the two agencies working on joint projects together to prepare them for eventual integration. For instance, the groups launched a new website on adverse drug reactions earlier in the year-a cooperative venture that was not without inadvertent controversy after consumers incorrectly extrapolated some reaction data.

Members of the Implementation Ministerial Council (IMC), the group overseeing ANZTPA's development, said they had also seen good progress on other joint projects between the two agencies, including progress on developing a "common regulatory framework for the application, assessment and approval of therapeutic products in Australia and New Zealand."

The venture also has a new public face, just announced today. ANZTPA's new website features information and news about the agency, and is similar in style to TGA's website. The website will be the source for much of the information coming out about the budding agency, including a planned release of a discussion paper regarding the agencies' joint framework.

Other projects in the works include a common recalls portal, early warning system and good manufacturing practice (GMP) audit system. All are scheduled to be completed by the end of the 2013 financial year, the IMC said.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.