Australian Drug Evaluation Committee (ADEC) 40th Anniversary
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Int J Pharm Med 2004; 18 (4): 225-226 1364-9027/04/0004-0225/$31.00/0 © 2004 Adis Data Information BV. All rights reserved.
Australian Drug Evaluation Committee (ADEC) 40th Anniversary John McEwen Therapeutic Goods Administration, Woden, ACT, Australia
The 40th anniversary of the Australian Drug Evaluation Committee, commonly known as ADEC, occurred in late July 2003. ADEC first met on Thursday 25 July 1963, under the Chairmanship of Dr Edgar Thomson, in the boardroom at the Royal Prince Alfred Hospital, Sydney. The Committee was composed of seven members eminent in the fields of clinical medicine and pharmacology. ADEC has met regularly since and its August 2003 meeting was its 229th meeting. Australia was centrally involved in the recognition of the teratogenicity of thalidomide. William McBride’s letter published in the Lancet in December 1961 attracted the world’s attention. In 1963, to a large extent as a result of the thalidomide experience, discussions took place between the Australian Department of Health and senior Australian clinicians on ways and means of more effectively exerting control over drugs causing serious adverse effects. The thalidomide experience had brought home to Australian health officials that there were not only benefits but also potential risks from the use of therapeutic compounds. As a result of these discussions, the then Minister for Health established an independent body, the ADEC, to advise on the safety of new drugs being imported into Australia and to formulate measures for the evaluation of possible adverse affects of drugs that were being used in Australia. The functions given to the new Committee were: • to make medical and scientific evaluations of such therapeutic substances that the Minister referred to it for evaluation; • to make medical and scientific evaluations of other therapeutic substances if, in the opinion of the Committee, it would be desirable to do so; and • to furnish such advice to the Minister as the Committee considered necessary related to the importation into, and the distribution within, Australia of therapeutic substances that were the subject of evaluations made by it. ADEC met three times during 1963. These meetings laid the foundations for what would become the evaluation process for new drug substances in Australia. General topics discussed at
these early meetings included the functions of the ADEC, the definition of a new drug, details of the future Australian drug evaluation process using comparisons with international practice at the time and the role of the individual medical practitioner in drug safety surveillance. Standards for submission of data for importation of medicines into Australia were introduced as a result of the early recommendations of the Committee. The Committee also sought to ensure that companies were required to provide information about risks, as well as benefits, in promotional material for health professionals. The early ADEC made a number of important decisions in relation to individual product groups. Drug substanc
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