Biomaterial Database

International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group. 1990

G A Faich, and W Castle, and Z Bankowski

Council for International Organizations of Medical Sciences, c/o World Health Organization, Geneva, Switzerland.

A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.

UI	MeSH Term	Description	Entries
D007391	International Cooperation	The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.	Foreign Aid,Treaties,Aid, Foreign,Cooperation, International,Treaty
D007880	Legislation, Drug	Laws concerned with manufacturing, dispensing, and marketing of drugs.	Drug Laws,Food, Drug and Cosmetic Act,Narcotic Laws,Drug Legislation,Drug Law,Law, Drug,Law, Narcotic,Laws, Drug,Laws, Narcotic,Narcotic Law
D009626	Terminology as Topic	Works about the terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.	Etymology,Nomenclature as Topic,Etymologies
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D004345	Drug Industry	That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.	Industries, Pharmaceutic,Industry, Drug,Industry, Pharmaceutic,Industry, Pharmaceutical,Pharmaceutical Industry,Drug Industries,Industries, Drug,Industries, Pharmaceutical,Pharmaceutic Industries,Pharmaceutic Industry,Pharmaceutical Industries
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012955	Societies, Medical	Societies whose membership is limited to physicians.	Medical Societies,Medical Society,Society, Medical
D014944	World Health Organization	A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.	Organization, World Health,WHO
D064420	Drug-Related Side Effects and Adverse Reactions	Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug