NZSMI disappointed ANZTPA proposal shelved

November 20, 2014: Consumer healthcare products industry body, the New Zealand Self-Medication Industry Association (SMI) says it is disappointed Government has once again shelved plans to create one medicines regulatory agency for both New Zealand and Australia.

An earlier proposal was shelved in 2007 and the sector has been working hard since then to reach an agreement to form the Australia and New Zealand Therapeutic Products Agency (ANZTPA).

“Many of our members operate in both countries 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,” comments SMI executive director, Tim Roper.

Mr Roper says the formation of a single regulatory body has been one of his organisation’s key platforms for a number of years.

“The SMI remains a strong supporter of the joint agency. The joint Australia New Zealand
Therapeutic Products Agency (ANZTPA) would have provided a unique opportunity to pursue best practice regulation through harmonisation and adoption of the best of both worlds. However, we appreciate the joint agency needs to be cost effective and efficient for both countries.”

Mr Roper says a single agency could enhance New Zealand’s competitive position in “the Asian Century” where members of the growing middle class are strong supporters of non-prescription medicines.

“We are concerned, however, about the prevailing attitude that the Australian regulatory scheme is the ‘gold standard’ to which New Zealand needs to harmonise. The New Zealand scheme is more progressive in at least two respects: scheduling (“switch”) and the
advertising of Pharmacist Only (Schedule 3) Medicines.

“We believe there are benefits for consumers to be gained from harmonising the regulatory framework and we would like to continue to work with Medsafe and the Therapeutic Goods Agency (TGA) to achieve that result,” says Mr Roper.

-ENDS-

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