Bénichou C
Division of Pharmacovigilance, Roussel Uclaf, Paris, France.
J Hepatol. 1990 Sep;11(2):272-6. doi: 10.1016/0168-8278(90)90124-a.
International reporting of adverse drug reactions by pharmaceutical manufacturers to national drug regulatory authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. The Council for International Organizations of Medical Sciences (CIOMS) undertook a pilot project to prepare such definitions and criteria, and proposed to use as its model a series of expert consensus meetings organized in France by the pharmaceutical company, Roussel Uclaf, with the participation of the official French network of pharmacovigilance. Under CIOMS auspices, an international meeting was organized to test the feasibility of adapting for international use the outcome of the French consensus meetings on drug-induced liver disorders. The meeting resulted in a series of proposed standard designations of drug-induced liver disorders and criteria of causality assessment.
制药商向国家药品监管当局进行国际药品不良反应报告，需要国际认可的不良反应标准定义和因果关系评估标准。国际医学科学组织理事会（CIOMS）开展了一个试点项目来制定此类定义和标准，并提议以制药公司罗素优克福（Roussel Uclaf）在法国组织的一系列专家共识会议为模型，法国官方药物警戒网络也参与其中。在CIOMS的主持下，组织了一次国际会议，以测试将法国关于药物性肝病的共识会议结果改编用于国际的可行性。会议产生了一系列关于药物性肝病的拟议标准名称和因果关系评估标准。
