Australian Regenerative Medicine Institute

The Australian national publicly subsidized: LICENSING(2)

he Australian national publicly subsidized: LICENSING(2)

This translates into approximately 230 calender days. In 1994/95, 856 prescription drugs were processed for inclusion in the Australian Register of Therapeutic Goods (33 for new chemical entities). When approved, the drug is entered on the Australian Register of Therapeutic Goods, and the drug can be sold in Australia and paid for by individuals; the drug can then be considered for inclusion in the PBS.

One aspect of the Australian licensing process that is different from that of the Canadian Healthcare system is the use of an expert advisory committee as a standard part of the review process for all major applications. The Australian Drug Evaluation Committee (first formed in 1967) is an independent statutory body comprising clinicians from all specialties as well as epidemiologists and toxicologists. It provides advice to the Department and Minister of Health and Family Services on applications to register drugs and on general policy issues in relation to drug regulation. The committee has the capacity to appoint subcommittees as required, of which there are two: the Australian Adverse Reactions Advisory Committee (ADRAC) (formed in 1970) and the Pharmaceutical Sub-committee (PSC). The PSC reviews the manufacturing aspects of applications before marketing approval, as requested by the TGA. ADRAC reviews all spontaneous adverse drug reactions that are reported to the Department of Health and Family Services under Australia’s voluntary reporting system for adverse reactions and provides advice to the TGA on regulatory action and any modification of labelling that may be required.

Category: Pharmaceutical

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

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