Regulatory Considerations regarding International Post-Marketing Surveillance

Abstract

Although technology is developing to permit the collection and worldwide dissemination of adverse reaction data gathered through postmarketing surveillance of drugs, national drug regulatory systems should not move to adopt international PMS reporting requirements without first evaluating the effects these requirements will have. Questions must be addressed such as what must be reported, when, by whom, and for what purpose. Of particular importance are the ways in which regulatory officials will use the international PMS data and the sanctions they might impose for failure to meet reporting requirements. If these issues are not successfully resolved, efforts toward high quality international PMS may be frustrated.