ASMI welcomes a renewed look at reforming cross-Tasman medicines regulation

20 June 2011

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The Australian Self-Medication Industry (ASMI), the industry body representing non-prescription consumer healthcare products today 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.

The Executive Director of ASMI, Dr Deon Schoombie 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," said Dr Schoombie.

"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).
However Dr Schoombie warns 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."

He said the exclusion of complementary medicines (CMs) from the five-year implementation plan was disappointing. However he hopes that once the agency is established and in operation, that CMs will be included in the joint regulatory arrangements.

"We hope that in time, the new joint agency will oversee the regulatory arrangements for the whole therapeutic goods industry including complementary medicines" said Dr Schoombie.
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy.

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298,