Introduction

The term "CIOMS" is in daily use in international pharmacovigilance departments. For example, CIOMS forms are used for expedited case reporting, CIOMS line listings are used for presenting groups of cases, and CIOMS frequency definitions are used in product information labelling. The aim of this chapter is to describe who or what CIOMS is and to examine the contributions that the individual working groups have made to present-day pharmacovigilance practice.

The Council for International Organisations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organisation which was established in 1949 under the auspices of the World Health Organisation (WHO) and the United Nations Educational, Scientific and Cultural Organisation (UNESCO). It is responsible for the collection and dissemination of informed opinion on new developments in biology and medicine, and exploring their social, moral, administrative and legal implications. In 1977 it was recommended that CIOMS should facilitate discussions between national regulatory authorities and pharmaceutical companies on policy matters by providing an independent forum. It also convenes groups of experts to make recommendations on specific topics when appropriate.

In 1986, CIOMS set up the first pharmaco-vigilance working group to discuss international reporting of adverse drug reactions (ADRs). Since then, five further working groups have completed recommendations and suggested guidelines for harmonisation of various aspects of pharmaco-vigilance (Table 25.1).

Table 25.1. The CIOMS initiatives.

Working group

Initiative

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