The Australian Drug Evaluation Committee (ADEC) was a
committee
A committee or commission is a body of one or more persons subordinate to a deliberative assembly or other form of organization. A committee may not itself be considered to be a form of assembly or a decision-making body. Usually, an assembly o ...
that provided independent scientific advice to the
Australian Government
The Australian Government, also known as the Commonwealth Government or simply as the federal government, is the national executive government of Australia, a federal parliamentary constitutional monarchy. The executive consists of the pr ...
regarding therapeutic
drugs
A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via inhalation, injection, smoking, ingestio ...
. 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
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertisi ...
(TGA). In 2010, ADEC was replaced by th
Advisory Committee on Prescription Medicines (ACPM)
ADEC provided 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 was the classification of drugs in Australia into
pregnancy categories.
The two main subcommittees of ADEC which were responsible for specific aspects of drug regulation in Australia:
*the
Adverse Drug Reactions Advisory Committee (ADRAC) (replaced in 2010 by the separate Advisory Committee on the Safety of Medicines, ACSOM);
*the Pharmaceutical Subcommittee – which made recommendations to ADEC on the
pharmaceutical
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
aspects (
chemistry
Chemistry is the scientific study of the properties and behavior of matter. It is a physical science within the natural sciences that studies the chemical elements that make up matter and chemical compound, compounds made of atoms, molecules a ...
,
quality control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements".
This approach plac ...
,
pharmacokinetics
Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to describing how the body affects a specific su ...
, etc.) of drugs proposed for registration (replaced by the pharmaceutical subcommittee of the ACPM).
See also
*
(ICH)
*
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA, US)
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
(EMEA, EU)
*
Health Products and Food Branch The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information ...
External links
ADEC website
{{Authority control
Evaluation
Defunct Commonwealth Government agencies of Australia
Medical and health organisations based in Australia
National agencies for drug regulation
Pharmacy in Australia