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). A committee is a (relatively) small group that can serve one of several functions: Governance: in organizations too large for all the members to participate in decisions affecting the organization as a whole, a committee (such as a Board of Directors) is given the power to make decisions. ... The Commonwealth of Australia is a constitutional monarchy, a federation, and a parliamentary democracy. ... This article does not cite any references or sources. ... Year 1963 (MCMLXIII) was a common year starting on Tuesday (link will display full calendar) of the Gregorian calendar. ... The Therapeutic Goods Administration or TGA is the regulatory body for drugs and therapeutic goods in Australia. ...

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. The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. ...

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

The Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee (ADEC) which monitors the safety of medicines in Australia. ... Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ... For other uses, see Chemistry (disambiguation). ... For the Jurassic 5 album, see Quality Control (album) In engineering and manufacturing, quality control and quality engineering are involved in developing systems to ensure products or services are designed and produced to meet or exceed customer requirements. ... Pharmacokinetics (in Greek: pharmacon meaning drug, and kinetikos meaning putting in motion) is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism. ...

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)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... hi “FDA” redirects here. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... The Ministry of Health, Labour and Welfare (厚生労働省; Kōsei-rōdō-shō) is one of ministries in the Japanese government. ...

External links

• ADEC website