Drug regulation in Australia

TGA

Australia has one of the highest cancer survival rates in the world. This is partly because the country has adopted population screening programs for breast, cervical, and colorectal cancers and provides population-level access to the HPV vaccine. It also suggests, however, that over the years the most important drugs have become widely available in a reasonable timeframe.

Drug regulation in Australia involves initially having prescription drugs registered by the Therapeutic Goods Administration (TGA), the authority responsible for regulating medicines, medical devices, blood, and tissues. However, the real key to availability is having the drugs listed on the Pharmaceutical Benefits Scheme, where they are subsidized by the Australian government.

Requirements for drug application depend on whether the drug will be sold over the counter without a prescription or on prescription (which would apply to most oncology drugs). There is a different system of listing complementary medicines, and there is a separate group for evaluating diagnostic tests (such as testing for the target of a targeted therapy).

For more details, go to: http://am.asco.org/drug-regulation-australia?et_cid=36125337&et_rid=977599084&linkid=Drug+Regulation+in+Australia

Michael Wonder

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Michael Wonder

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