Australian Drug Evaluation Committee (ADEC)

Introduction

The Australian Drug Evaluation Committee (ADEC) was formed in 1963 and given the role of providing independent, scientific advice on new drugs, within the policy framework of the time, to the Federal Government. The committee first met on Thursday 25 July of that year, and although the then Federal Minister for Health, the Honourable H W Wade, was unable to attend, he sent a message to the committee outlining its role.

The committee has continued to meet regularly since it came into being and when the Therapeutic Goods Act 1989 (the Act) came into force, the committee's establishment was carried forward under Regulation 36 (1) of regulations to the Act (the Therapeutic Goods Regulations). The Therapeutic Goods Act provides the legislative basis for the regulation of therapeutic drugs and medical devices within Australia). In December 1998, the committee held its 200th meeting, marking 35 years of service by ADEC to the Australian community.

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Role of ADEC

The ADEC is appointed by the Minister for Health and Ageing and provides advice to the Minister and the Secretary of the Commonwealth Department of Health and Ageing through the Therapeutic Goods Administration, on:

• the quality, risk-benefit, effectiveness and access within a reasonable time of any drug referred to it for evaluation;
• medical and scientific evaluations of applications for registration of prescription drugs (e.g. new chemical entities, new forms of previously registered drugs and therapeutic variations to registered drugs).

The Committee also provides services to other Government departments, committees and community-based organisations on a wide variety of regulatory matters related to prescription medicines.

ADEC membership

The Minister for Health and Ageing appoints the members of the Australian Drug Evaluation Committee under subregulation 36 of the Therapeutic Goods Regulations 1990. The Minister must appoint to the Committee six or seven core members and ten to twenty associate members. Of the core members, at least:

• three must be eminent medical practitioners with at least two specialists in clinical medicine; and
• one must be a pharmacologist, or hold a degree in science, specialising in pharmaceutical science.

The associate members must include:

• at least one pharmaceutical chemist with recent manufacturing experience in therapeutic goods; and
• at least one toxicologist; and
• a medical practitioner in general practice.

All associate members have specialist qualifications and experience in fields of medicine complementary to that of the core membership. Associate members are invited by the chair to attend meetings according to the agenda of each meeting.

Membership

NB: Decisions of the ADEC are made on a collegiate basis. All correspondence to the committee must be made via the ADEC Secretariat.

Chair

Dr Geoffrey Herkes
North Shore Medical Centre
St Leonards NSW

Core members

Associate members

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ADEC meeting dates

ADEC meeting dates for 2008

2008 ADEC meeting	Cut-off date	ADEC meeting date
2008/1 (256)	7 January 2008	1 February 2008
2008/2 (257)	6 March 2008	4 April 2008
2008/3 (258)	13 May 2008	6 June 2008
2008/4 (259)	8 July 2008	1 August 2008
2008/5 (260)	9 September 2008	3 October 2008
2008/6 (261)	11 November 2008	5 December 2008

ADEC meeting dates for 2009

2008 ADEC meeting	Cut-off date	ADEC meeting date	Venue
2009/1 (262)	12 January 2009	6 February 2009	Canberra
2009/2 (263)	9 March 2009	3 April 2009	Canberra
2009/3 (264)	12 May 2009	5 June 2009	Sydney
2009/4 (265)	14 July 2009	7 August 2009	Sydney
2009/5 (266)	8 September 2009	2 October 2009	Canberra
2009/6 (267)	10 November 2009	4 December 2009	Canberra

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ADEC Subcommittees

Adverse Drug Reactions Advisory Committee

The Adverse Drug Reactions Advisory Committee (ADRAC) reports to ADEC on all matters relating to adverse drug reactions <http://www.tga.gov.au/problem/index.htm#medicines>. The committee publishes regular bulletins and contributes to the WHO data bank on adverse drug reaction reports.

For more information, including membership and meeting dates, see: Adverse Drug Reactions Advisory Committee <http://www.tga.gov.au/adr/index.htm>.

ADEC Pharmaceutical Subcommittee

The Pharmaceutical Subcommittee makes recommendations to ADEC on the pharmaceutical chemistry, quality control, bioavailability and pharmacokinetics of prescription medicines proposed for registration in Australia. It may act as an arbitrator between the Therapeutic Goods Administration and the pharmaceutical industry. The members are invited by the chair to attend meetings according to each agenda.

ADEC Pharmaceutical Subcommittee membership

Chair:

Professor Julia Potter

Members

• Associate Professor Robin Allan
• Professor Robert Beal
• Professor Philip Board
• Professor Yvonne Cossart
• Associate Professor Michael Dawson
• Dr David Foster
• Dr Geoffrey Herkes
• Mr Michael Kimber
• Dr Carl Kirkpatrick
• Mr Peter Lublin
• Professor Ross McKinnon
• Professor Andrew McLachlan
• Associate Professor Iqbal Ramzan
• Professor Michael Roberts
• Emeritus Professor Lloyd Sansom, AO
• Dr Desmond B Williams

ADEC Pharmaceutical Subcommittee (PSC) meeting dates

ADEC Pharmaceutical Subcommittee (PSC) meeting dates for 2008

Meeting No.	Cut-off date*	Meeting date
2008/1 (118)	2 January 2008	21 January 2008
2008/2 (119)	3 March 2008	25 March 2008
2008/3 (120)	7 May 2008	26 May 2008
2008/4 (121)	2 July 2008	21 July 2008
2008/5 (122)	3 September 2008	22 September 2008
2008/6 (123)	5 November 2008	24 November 2008
*Cut-off dates are for administrative purposes only

ADEC Pharmaceutical Subcommittee (PSC) meeting dates for 2009

Meeting No.	Cut-off date*	Meeting date
2009/1 (124)	7 January 2009	27 January 2009
2009/2 (125)	3 March 2009	23 March 2009
2009/3 (126)	6 May 2009	25 May 2009
2009/4 (127)	8 July 2009	27 July 2009
2009/5 (128)	2 September 2009	21 September 2009
2009/6 (129)	3 November 2009	23 November 2009
*Cut-off dates are for administrative purposes only

ADEC statements

Hormone replacement therapy

• ADEC summary statement on HRT
  <http://www.tga.gov.au/docs/html/hrtadec3.htm>
  16 April 2004
• Update to ADEC statement on use of hormone replacement therapy
  <http://www.tga.gov.au/docs/html/hrtadec2.htm>
  17 October 2003
• ADEC statement on use of hormone replacement therapy
  <http://www.tga.gov.au/docs/html/hrtadec.htm>
  14 August 2003

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