Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs

Abstract

It has become increasingly difficult, especially for multinational pharmaceutical companies, to remain current and comply efficiently with the multiplicity of regulations and guidelines in various countries throughout the world governing clinical drug safety surveillance and reporting. In order to obtain a better understanding of current and pending obligations for manufacturers, a questionnaire was completed with input from medical, legal, and regulatory personnel in Pfizer's 47 subsidiaries covering some 100 countries outside the United States. Twenty-seven countries, including the United States, have some formal regulations which cover: (a) expedited reporting of serious or other special adverse events (20 countries); (b) periodic safety update reports (13 countries); and (c) post-marketing surveillance studies (a few countries). Details by country are discussed on the various determinants for expedited reporting (seriousness; expectedness; causality; timing; local or foreign origin; investigational or marketed drug; and others) and for periodic reporting. In view of the many differences documented, there is a compelling need for standardization among regulatory bodies of the definitions and requirements in this important public health area. Approaches initiated by The Council for International Organizations of Medical Sciences (CIOMS) are discussed as a reasonable approach.