SMI welcomes renewed look at single medicines regulator

Better health for New Zealanders through the development of responsible self-medication

June 21, 2011

MEDIA STATEMENT

SMI welcomes renewed look at single trans-Tasman medicines regulator

The New Zealand Self-Medication Industry Association (SMI), the industry body representing non-prescription consumer healthcare products, welcomed the announcement of plans for a renewed examination of a joint Australia-New Zealand medicines agency.

Australia’s Prime Minister, Julia Gillard, and New Zealand’s Prime Minister, John Key, announced a five-year staged plan which will see Australia’s Therapeutic Goods Administration and New Zealand’s Medsafe work together in areas of common interest, and develop a single regulatory framework - with the intention of becoming a joint agency in the future.

SMI executive director Tim Roper said the proposal to join the two regulatory agencies represents a major step towards building a world-class regulatory system.

“Harmonising regulatory arrangements for therapeutic products between Australia and New Zealand has the potential to streamline procedures and also bring a more contemporary approach to regulation in each country,” he said.

“The move towards a single agency is a positive step for the medicines industry, and will provide consistency for manufacturers in areas of licensing, packaging, and advertising of therapeutic products, including those sold over-the-counter (OTC).”

Mr Roper warned, however, that combining the two regulatory bodies will not be without some challenges.

“No-one should underestimate the difficulties that this exercise presents. But the industry stands ready to assist in bringing about meaningful reform which will significantly benefit the communities of both countries.

“The OTC medicines sector was very supportive of earlier attempts to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA), which ultimately foundered following a break-down of negotiations between Australia and New Zealand.

“It’s to be hoped that some of the lessons from earlier experiences have been absorbed, and will allow the two governments and their parliaments to overcome some of the differences that derailed previous attempts.”
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