In 1986 CIOMS set up the Working Group on International Reporting of Adverse Drug Reactions to explore means of coordinating and standardizing international adverse drug reporting by pharmaceutical manufacturers to regulatory authorities. The rationale of the formation of this group was the recognition that ADR surveillance is critical to assuring the safety of approved drugs in practice.
The Working Group was composed of representatives of six regulatory agencies and seven pharmaceutical manufacturers, as well as observers from the World Health Organization, the International Federation of Pharmaceutical Manufacturers Associations, and the Bundesverband der Pharmazeutischen Industrie I.V., Federal Republic of Germany. Its agenda was limited to post-marketing reporting of adverse drug reactions occurring in one country and which the pharmaceutical industry should report to regulatory authorities in other countries where the drug is also marketed.