Chemistry International

This book is a revised and expanded edition of the first internationally agreed guidelines covering the minimum drug safety information that should be communicated by manufacturers to physicians and other prescribers. Originally published as the CIOMS Working Group III report, the "Core Safety Information" specified in the guidelines has been widely endorsed as a standard for the preparation of all official national data sheets, package inserts, product labels, and other official statements issued by manufacturers. The original guidelines were produced in response to the need to harmonize drug safety information. As their principal objective, the guidelines aim to ensure that data sheets contain the information most needed to help prescribers balance a product’s risks against its benefits, and thus make good therapeutic decisions. The book also includes the new report of CIOMS Working Group V. This report extends the original guidelines to include recommended safety information on drugs undergoing investigation. Intended to guide the content of company investigators’ brochures, this "Development Core Safety Information" then forms the basis for the core safety information eventually issued for the marketed product. The report of Working Group V is published as an additional set of proposals for the assessment and presentation of safety information in investigators’ brochures. Proposals, which follow the same practical approach used to produce core clinical safety information, are intended to provide researchers with all relevant clinical and non-clinical information and to assist pharmaceutical companies in meeting their reporting obligations. In addition, guidance is provided on the global distribution to investigators of new safety information, such as 7-day and 15-day alerts to serious, unexpected adverse reaction. The proposals should also facilitate the work of ethics review committees when assessing the benefits and risks to participants in clinical trials.

The book concludes with the text of the European Summary of Product Characteristics and a summary of the U.S. FDA Requirements, examples of illustrative drug scenarios used by the working group, and a model of Core Safety Information proposed for a fictitious drug.