In 1995, the Council for International Organizations of Medical Sciences (CIOMS) Working Group III report was drafted in response to the need to harmonize core drug safety information. It has been widely endorsed by pharmaceutical manufacturers as a standard for preparation of information for data sheets, package inserts and product labelling.
The complementary Guidelines for Preparing Core Clinical-Safety Information on Drugs include recommended safety information for drugs undergoing investigation, development of core safety information to be included in investigator's brochures, and information to support product approval. Relevant information is provided to researchers on the 7-day and 15-day global reporting requirements.
A new and important proposal is set out on the threshold requirements and assessment of risk benefit of a marketed product when a significant new safety signal is identified. The Guidelines conclude with the text of the European Union Summary of Product Characteristics and the US Food and Drug Administration General Requirements on Content and Format of Labelling for Human Prescription Drugs.
Guidelines for Preparing Core Clinical-Safety Information on Drugs, Including New Proposals for Investigators Brochures. Report of CIOMS Working Groups III and V. Available from: CIOMS, 1211 Geneva 27, Switzerland. ISBN 92 9036 070 4 Price: Sw. fr. 15.-