Presents and explains the standardized format of a proposed single international summary report to be used by drug manufacturers for the periodic updating of safety data on approved pharmaceutical products. Proposals reflect the consensus reached, following two years of meetings and debate, by a CIOMS Working Group representing 12 pharmaceutical companies and 10 regulatory agencies. The aim of these meetings was to give manufacturing companies a uniform set of procedures for reporting safety information to regulatory bodies. Apart from improving inter-regulatory communications, these uniform procedures should facilitate the work of doctors and scientists responsible for monitoring drug safety in industry. The need to harmonize safety information on drug products is highlighted in the opening section, which reports the results of a survey of current regulations for periodic safety updates in all countries known to have some safety-update reporting requirements. Major differences are noted in the anniversary dates of licensing approval, in the timing of required reports, and in the types and amounts of data required. The proposals, which cover both the scope and content of a periodic drug-safety update, are presented in the form of a nine-point outline of the core information which should be included in any periodic report. Key points agreed on include the frequency of review and reporting, the need for cumulative information on the drugs licensed status for marketing, and the circumstances under which detailed utilization data should be supplied. Other sections of the book explain how the Working Group reached consensus and describe several issues that will need to be resolved in the future. The book concludes with a 21-page example of a periodic safety update for a fictitious drug product.

WHODOC

WHO monograph

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