According to the World Health Organization (WHO) pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is as follows:

A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function (WHO, 1972).



In 1986, CIOMS set up its first Working Group on pharmacovigilance, a 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. 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.

In 1977, a CIOMS Conference on “Trends and Prospects in Drug Research and Development” recommended that, by offering an independent forum, CIOMS should facilitate discussion of policy matters between the research-based pharmaceutical companies and national regulatory authorities, and, when indicated convene groups of experts to make recommendations on specific issues.



Since the CIOMS Working Group I “International Reporting of Adverse Drug Reactions” (1990) ten numbered Working Groups and several unnumbered Working Groups were launched to address hot topics of pharmacovigilance. All produced valuable reports as a result:-

  • International Reporting of Periodic Drug Safety Update Summaries (CIOMS Working Group II 1992)
  • Guidelines for Preparing Core Clinical Safety Information on Drugs (CIOMS Working Group III, 1995)
  • Benefit-risk balance for marketed drugs (CIOMS Working Group IV, 1998)