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TGA review released

Australia's medicinal product regulatory body, the Therapeutic Goods Administration (TGA), is set to streamline regulatory procedures, reinforcing its commitment to protecting public health and safety.

Releasing the KPMG Review of Australian regulations on medicinal products today, Senator Bob Woods, Parliamentary Secretary to the Minister for Health and Family Services, said the Government would consider all recommendations made in the report to ensure the industry and public were receiving the best possible service.

"We will look at all the recommendations including closer harmonisation with New Zealand regarding drug regulation, increased involvement by stakeholders in the regulatory process and closer involvement of industry to assist the TGA in improving the process of evaluation of complementary medicines," Senator Woods said.

"Industry, consumers, professional groups and departmental officials have made a great contribution through participation in the review and I will now consider all the issues raised in the report with a view to formulating the Government's response in February.

"With regard to the review's examination of Australia's export

arrangements, I have asked the Therapeutic Goods Administration to begin further consultation with industry in order to assist the Government's response to the review and ensure any unnecessary regulatory obstacles for Australian manufacturers and exporters are removed."

The Review was conducted by KPMG Management Consulting.

Senator Woods said he asked the Department of Health and Family Services to facilitate the review in mid-1996 to investigate ways to improve the speed, effectiveness and cost- efficiency of Australia's current regulatory approach to medicinal products while reflecting the Government's high priority placed on protecting public health and safety.

The Review has also made recommendations on issues canvassed through the Industry Commission's Review of the Pharmaceutical Industry, including use of overseas drug evaluations and brand advertising of Schedule 3 products. These issues will be addressed in the Government response to the Industry Commission report, also due in February.

Further information:

Nicholas Harford, Senator Woods' office, 02 9689 2299;

0412 131 342