Australian Drug Evaluation Committee
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2007-09-18T05:38:49Z
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The '''Australian Drug Evaluation Committee''' or '''ADEC''', is a [[committee]] that provides independent scientific advice to the [[Government of Australia|Australian Government]] regarding therapeutic [[medication|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).
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 category|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)]]
==External links==
*[http://www.tga.gov.au/docs/html/adec/adec.htm ADEC website]
[[Category:Evaluation]]
[[category:Government entities of Australia]]
[[Category:Healthcare in Australia]]
[[Category:Pharmaceuticals policy]]