Australian Regenerative Medicine Institute

The Australian national publicly subsidized: LICENSING(1)

The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health, is responsible for licensing a drug for marketing. It is similar to the Canadian Health Protection Branch, Health Canada. It operates under the Therapeutic Goods Act and, as is the case for most drug regulatory authorities, reviews company submissions to ensure that drugs approved for marketing are of adequate quality, safety and efficacy. As with most regulatory authorities, the TGA has been under considerable pressure from the medical profession, the public and the pharmaceutical industry to reduce review times, particularly for applications for new Canadian drugs.

Following the Baume review of the agency in 1991, the Therapeutic Goods Act was amended in 1992 to include a statutory requirement that major applications be decided within 255 working days after being accepted for evaluation. This was coupled with the introduction of fees for evaluation so that the agency now receives about 50% of its funding from the pharmaceutical industry. Over the past three years there has been a substantial decrease in the time to decision on most applications. The mean review time for a major new chemical entity is approximately 160 working days with the agency, with ‘time out’ for companies to respond to questions from the authority.

Category: Pharmaceutical

Tags: Australian Pharmaceutical Benefits Scheme, Canadian health care, Pharmaceutical policy, Pharmacoeconomics

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