How Australia’s drug approval process works

2 min read
opera house
First Published: 
Feb 2007

Key Learnings contained in this article:

Therapeutic goods are those associated with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; influencing, inhibiting or modifying a physiologic process; testing the susceptibility of persons to a disease or ailment; influencing, controlling or preventing conception; testing for pregnancy; or replacing or modifying parts of the anatomy.

The TGA outlines the requirements for inclusion in the ARTG as well as regulations on advertising, labelling, product appearance, and appeal guidelines. Requirements for safe storage or for scheduled substances are subject to State or Territory legislation.

Medicines included in the database are either registered (ie, higher risk medicines: prescription medicines, some nonprescription medicines) or listed (ie, lower risk medicines: some over-the-counter medicines, herbal medicines, ayurvedic, traditional Chinese, Australian indigenous medicines, other complementary medicines, vitamins and minerals, nutritional supplements, homeopathic medicines, and aromatherapy products).

When each medicine is approved for marketing, it is assigned either an AUST R number (registered) or AUST L number (listed medicines).

Drug review

During the review process, the TGA requirements for data follow those for the European Union; however, they will accept US dossiers (by prior agreement) for high priority drugs (eg, drugs to treat cancers).

Postmarketing activities of the TGA include investigating reports of problems, laboratory testing of products on the market, and monitoring to ensure compliance with the legislation. For these activities, the TGA has a problem-reporting system, a recall unit, and the Australian Drug Reactions Advisory Committee, which publishes a regular bulletin.

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