Regulatory Aspects of Pharmacovigilance

Abstract

Pharmaceutical companies have a responsibility to make the use of their medicines as effective and as safe as possible. Hence, companies need to conduct effective pharmacovigilance throughout the life cycle of all medicinal products, so that accurate, well-informed and up-to-date information is provided to physicians, pharmacists and patients. In addition, companies must keep regulatory authorities informed with regard to the ongoing safety profiles of their products so that the authorities can fulfil their own obligations to protect public health. Each company should collect safety data on all of its products, from all available sources on a worldwide basis, and have appropriate evaluation and reporting mechanisms in place. However, the current diversity of regulatory requirements for reporting adverse drug reactions (ADRs) results in different authorities requesting that information from the same source be presented according to different inclusion criteria, formats and time intervals. Despite the best efforts of the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonization (ICH), it is evident that effort put into compliance with diverse ADR reporting requirements draws resources away from the medical evaluation of safety signals. Thus, a single set of standards for the worldwide communication of safety information is still required in order to facilitate a shift in emphasis away from the administration of safety data towards more cost-effective identification and evaluation of important safety signals.