International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.
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.
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Council for International Organizations of Medical Sciences, c/o World Health Organization, Geneva, Switzerland.
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D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D012955:Societies, Medical; D009626:Terminology as Topic; D014944:World Health Organization