Australian Drug Evaluation Committee (ADEC)
ADEC
ADEC meetings
- ADEC meeting dates
- ADEC resolutions (February 1998 to present)
- PSC recommendations (July 2006 to present)
- The resolutions for approval of medicines by the ADEC are recommendations for further action by the TGA and do not constitute approvals in their own right.
ADEC statements & publications
- Prescribing Medicines in Pregnancy, 4th edition
<http://www.tga.gov.au/docs/html/medpreg.htm> - Hormone replacement therapy
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.
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
- Professor Stephen Clarke
Concord Repatriation General Hospital
Department of Medicine
Concord NSW - Dr Catherine Hill
The Queen Elizabeth Hospital
Rheumatology Department
Woodville SA - Associate Professor Paul Pavli
The Canberra Hospital
Gastroenterology Unit
Garran ACT
- Dr Stephen Phillips
Maroochydore QLD - Professor Julia Potter
ACT Pathology
The Canberra Hospital
Garran ACT - Associate Professor Philip Robinson
Department of Respiratory Medicine
Royal Children's Hospital
Parkville VIC
Associate members
- Associate Professor Shane Carney
School of Medicine and Public Health
University of Newcastle
Callaghan NSW - Dr Allen Cheng
Alfred Hospital
Dept of Epidemiology and Preventive Medicine
Melbourne VIC - Dr Catherine Cole
Princess Margaret Hospital for Children
Department of Haematology
Perth WA - Dr Alison Davis
The Canberra Hospital
Medical Oncology Unit
Garran ACT - Emeritus Professor Gordon Johnson
Director Mood Disorders Clinic
Northside Clinic
Greenwich NSW - Mr Peter Lublin
Pharmaceutical Subcommittee of ADEC
Balmain NSW - Associate Professor Anne Mijch
North Balwyn VIC - Professor Michael Moore
Honorary Professor
National Research Centre for Environmental Toxicology
Archerfield QLD - Dr Aiden O'Loughlin
North Shore Private Hospital
St Leonards NSW
- Associate Professor Peter Pillans
Princess Alexandra Hospital
Director of Clinical Pharmacology
Woolloongabba QLD - Professor Brian Priestly
Alfred Hospital
Dept of Epidemiology and Preventive Medicine
Melbourne VIC - Dr Geoffrey Schembri
Royal North Shore Hospital
Department of Nuclear Medicine
St Leonards NSW - Associate Professor David Scott
St Vincent's Hospital
Department of Anaesthesia
Fitzroy VIC - Dr David Smallwood
Royal Melbourne Hospital
Department of Respiratory Medicine
Parkville VIC - Professor Duncan Topliss
The Alfred Hospital
Department of Endocrinology and Diabetes
Melbourne VIC - Associate Professor Beverley Vollenhoven
Reproductive Endocrinologist & Infertility Specialist
Clayton VIC - Dr Thomas Walker
Ophthalmologist
Yarralumla ACT - Associate Professor John Ziegler
Sydney Children' Hospital
Department of Immunology and Infectious Diseases
Randwick NSW
ADEC meeting dates
ADEC meeting dates for 2009
| Meeting No. | Cut-off date | ADEC meeting date | Venue |
|---|---|---|---|
| 2009/1 (262) | 12 January 2009 | 6 February 2009 | Canberra |
| 2009/2 (263) | 10 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 |
ADEC meeting dates for 2010
| Meeting No. | Cut-off date | ADEC meeting date | Venue |
|---|---|---|---|
| 2010/1 (268) | 11 January 2010 | 5 February 2010 | Canberra |
| 2010/2 (269) | 16 March 2010 | 9 April 2010 | Canberra |
| 2010/3 (270) | 10 May 2010 | 4 June 2010 | Sydney |
| 2010/4 (271) | 13 July 2010 | 6 August 2010 | Sydney |
| 2010/5 (272) | 7 September 2010 | 1 October 2010 | Canberra |
| 2010/6 (273) | 9 November 2010 | 3 December 2010 | Canberra |
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
- Professor Robert Beal
- Dr Juleen Cavanaugh
- Associate Professor Mary Collins
- Associate Professor Michael Dawson
- Dr David Foster
- Clinical Associate Professor Geoffrey Herkes
- Mr Michael Kimber
- Associate Professor Carl Kirkpatrick
- Mr Peter Lublin
- Professor Ross McKinnon
- Professor Andrew McLachlan
- Professor Peter McMinn
- 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 2009
| Meeting No. | Cut-off date* | Meeting date |
|---|---|---|
| 2009/1 (124) | 7 January 2009 | 27 January 2009 |
| 2009/2 (125) | 4 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) | 4 November 2009 | 23 November 2009 |
| *Cut-off dates are for administrative purposes only | ||
ADEC Pharmaceutical Subcommittee (PSC) meeting dates for 2010
| Meeting No. | Cut-off date* | Meeting date |
|---|---|---|
| 2010/1 (130) | 6 January 2010 | 27 January 2010 |
| 2010/2 (131) | 10 March 2010 | 29 March 2010 |
| 2010/3 (132) | 5 May 2010 | 24 May 2010 |
| 2010/4 (133) | 7 July 2010 | 26 July 2010 |
| 2010/5 (134) | 1 September 2010 | 20 September 2010 |
| 2010/6 (135) | 3 November 2010 | 22 November 2010 |
| *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
ADEC publications
Prescribing Medicines in Pregnancy, 4th edition
<http://www.tga.gov.au/docs/html/medpreg.htm>
ADEC meeting resolutions
The resolutions for approval of medicines by the ADEC are recommendations for further action by the TGA and do not constitute approvals in their own right.
- ADEC resolutions (February 1998 to present)
<http://www.tga.gov.au/docs/html/adec/adecrecs.htm> - PSC recommendations (July 2006 to present)
<http://www.tga.gov.au/docs/html/adec/pscrecs.htm>
