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

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  • 1Council 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.

[PubMed - indexed for MEDLINE]
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