Australia and New Zealand have abandoned plans to create a joint medicines regulatory agency, after a review found it would not create adequate cost benefits for either nation.
In June 2011, the Prime Ministers of Australia and New Zealand signed an agreement to start work on the establishment of the Australia New Zealand Therapeutic Products Agency (ANZTPA), which would replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) over a period of five years.
However, work to establish ANZTPA will now end, although the two nations will continue to cooperate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators, said Australia and New Zealand’s Health Ministers, Peter Dutton and Jonathan Coleman.
The TGA and Medsafe will also continue to explore “other trans-Tasman regulatory harmonisation activities that represent potential value to both countries, and that build upon earlier business-to-business projects,” they said.
These include the development of a new information-sharing agreement and formalising mutual recognition of Good Manufacturing Practice (GMP) audits, work which will increase the potential for regulatory alignment over time to reduce compliance costs.
No changes are to be made to Australia’s TGA following the scrapping of the joint agency plans, but New Zealand’s Medsafe will now undergo an upgrade.
“I have asked the Ministry of Health to develop a comprehensive regulatory scheme for therapeutic products in New Zealand. It is important we modernise our regulation of medicines. There are benefits in bringing medicines, devices, cell and tissue therapies under a single cost-effective regulatory framework,” said Dr Coleman.
Industry body the New Zealand Self-Medication Industry Association (SMI) said it was disappointed that the ANZTPA plans had been shelved. “Many of our members operate in both counties so it makes sense to have one regulatory system for scheduling, labelling and advertising in both markets. Having different interpretations in each market is a challenge and adds to costs and delays in bringing products to market,’ said SMI executive director Tim Roper.
He also noted the industry group’s concern “about the prevailing attitude that the Australian regulatory scheme is the ‘gold standard’ to which New Zealand needs to harmonise. In fact, said Mr Roper, “the New Zealand scheme is more progressive in at least two respects – scheduling (‘switch’) and the advertising of Pharmacist Only (Schedule 3) Medicines.”
– Plans for the ANZTPA were originally put forward back in December 2003, when the two nations signed an agreement to replace the TGA and Medsafe with a single agency to regulate therapeutic products, including medical devices, prescription and over-the-counter and complementary medicines, in both countries. This agency was then supposed to begin work in 2005, but problems including massive controversy over proposals to include complementary medicines – which were not currently scrutinised by Medsafe – in its remit, led to New Zealand pulling out of the deal in 2007.
