Sets out a carefully developed and tested procedure for the standardized reporting, by manufacturers to regulators, of postmarketing adverse drug reactions occurring in foreign markets. The procedure, which is now published in its final form, is the culmination of a three-year project initiated by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO. The main part of the book presents and explains the CIOMS procedure for the international reporting of adverse drug reactions. The procedure, which was worked out and agreed upon by representatives of six regulatory agencies and seven multinational pharmaceutical companies, employs a uniform set of definitions and procedures, a fixed time-frame for submission of the report, and a reporting form with standardized elements and format. Prior to finalization, the scheme was pretested in a two-year pilot project involving seven manufacturers and some 40 affiliates. The second half of the book presents evaluations of the scheme prepared by each of the participating regulatory agencies and manufacturers. While pointing out some problems in the implementation of the scheme and use of the reporting form, these first-hand experiences overwhelmingly underscore the feasibility and utility of the scheme, which has already been adopted for use in the United Kingdom, the United States of America, the Federal Republic of Germany, and Italy.

DC.CIOMS

WHODOC

WHO monograph

4