Australian Drug Evaluation Committee

The Australian Drug Evaluation Committee or ADEC, was a committee

Committee

A committee is a type of small deliberative assembly that is usually intended to remain subordinate to another, larger deliberative assembly—which when organized so that action on committee requires a vote by all its entitled members, is called the "Committee of the Whole"...

that provided independent scientific advice to the Australian Government

Government of Australia

The Commonwealth of Australia is a federal constitutional monarchy under a parliamentary democracy. The Commonwealth of Australia was formed in 1901 as a result of an agreement among six self-governing British colonies, which became the six states...

regarding therapeutic drugs

Medication

A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...

. 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

Therapeutic Goods Administration

The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...

(TGA). In 2010, ADEC was replaced by the 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

Pregnancy category

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. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast...

.

The two main subcommittees of ADEC which were responsible for specific aspects of drug regulation in Australia:

the Adverse Drug Reactions Advisory Committee
Adverse Drug Reactions Advisory Committee
The Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee which monitors the safety of medicines in Australia...

(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 aspects (chemistry
Chemistry
Chemistry is the science of matter, especially its chemical reactions, but also its composition, structure and properties. Chemistry is concerned with atoms and their interactions with other atoms, and particularly with the properties of chemical bonds....

, quality control
Quality control
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...

, pharmacokinetics
Pharmacokinetics
Pharmacokinetics, sometimes abbreviated as PK, is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism...

, etc) of drugs proposed for registration (replaced by the pharmaceutical subcommittee of the ACPM).

See also