TGA reform of non-prescription medicines evaluation off to a good start

19 September 2012

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The Australian Self-Medication Industry (ASMI) today welcomed the latest initiatives outlined by the Therapeutic Goods Administration (TGA) relating to the Business Process Reform for over-the-counter (OTC) medicines.

The Executive Director of ASMI, Dr Deon Schoombie said the reform should provide greater certainty and predictability for those dealing with the TGA in relation to OTC medicines.

"The non-prescription products industry welcomes these measures which aim to increase the flow of information, improve certainty and clarity, and produce more timely TGA decisions," Dr Schoombie said.

The consultation paper issued by the TGA proposes a series of risk-related categories for OTC medicines, which would be used to guide medicine applications and evaluation.
"We think that the move to a more appropriate risk/benefit model for OTC medicines makes good sense, and look forward to working with the TGA to help bring about a more efficient process, and more timely consumer access to medicines," he said.
"This process should help to provide a clearer pathway to approval, and also reduce red tape and improve transparency around TGA decision-making," he said.
The BPR process is being undertaken by TGA in conjunction with the New Zealand regulator, Medsafe, in the lead up to the creation of the Australia New Zealand Therapeutic Products Agency (ANZPTA), scheduled for 2016.
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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. www.asmi.com.au

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