Australian Drug Evaluation Committee
- 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).
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
ee 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]
Wikimedia Foundation.
2010.
Look at other dictionaries:
Australian Drug Evaluation Committee — noun a federal committee formed to consider and evaluate new drugs to be marketed; provides an advisory and surveillance service …
Evaluation (disambiguation) — Evaluation is the process of characterizing and appraising something of interest or of determining the value of an expression (mathematics). Computer science * determining the value of an expression (programming) * Eager evaluation or strict… … Wikipedia
Australian Medicines Handbook — The Australian Medicines Handbook or AMH is a medical reference text commonly used in practice by health professionals (particularly general practitioners and pharmacists) in Australia. It is a highly regarded source of concise, independent drug… … Wikipedia
Adverse Drug Reactions Advisory Committee — 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. ADRAC evaluates reports from the Adverse Drug Reactions Unit of the… … Wikipedia
drug use — Introduction use of drugs for psychotropic rather than medical purposes. Among the most common psychotropic drugs are opiates ( opium, morphine, heroin), hallucinogens (LSD, mescaline, psilocybin), barbiturates, cocaine, amphetamines,… … Universalium
List of Australian Commonwealth Government entities — Australia This article is part of a series about the Politics and government of Australia … Wikipedia
List of Western Australian government agencies — *Abalone Management Advisory Committee *Aboriginal Affairs Co ordinating Committee (currently inactive) *Aboriginal and Remote Communities Power Supply Project Steering Committee *Aboriginal Cultural Material Committee *Aboriginal Economic… … Wikipedia
List of Western Australian courts and tribunals — Courts= *Coroner s Court of Western Australia *District Court of Western Australia *Magistrates Court of Western Australia *Supreme Court of Western Australia *Western Australia Industrial Relations Commission*Industrial Magistrates Court… … Wikipedia
Therapeutic Goods Administration — The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. It is a Division of the Australian Department of Health and Ageing… … Wikipedia
List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T … Wikipedia
