Australian Drug Evaluation Committee

The Australian Drug Evaluation Committee or ADEC, is a committee that provides independent scientific advice to the Australian Government regarding therapeutic drugs. The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 (Cth) as part of the Therapeutic Goods Administration (TGA).

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ADEC provides advice to the Minister for Health and Ageing and the Secretary of the Department of Health on:

• quality, risk-benefit, effectiveness and accessibility of drugs referred to ADEC for evaluation
• medical and scientific evaluations of applications for registration of new drugs

An important role of ADEC is the classification of drugs in Australia into pregnancy categories.

There two main subcommittees of ADEC which are responsible for specific aspects of drug regulation in Australia:

• the Adverse Drug Reactions Advisory Committee (ADRAC);
• the Pharmaceutical Subcommittee – which makes recommendations to ADEC on the pharmaceutical aspects (chemistry, quality control, pharmacokinetics, etc) of drugs proposed for registration

See also

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Food and Drug Administration (FDA, USA)
• European Medicines Agency (EMEA, EU)
• Ministry of Health, Labour and Welfare (Japan)