Postmarket surveillance: a review on key aspects and measures on theeffective functioning in the context of the United Kingdom andCanada

摘要

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadianjurisdiction, are two of the most successful postmarketing surveillance systemsimplemented across the world. Therefore, this article intends to discusspostmarketing surveillance and its role in the context of the United Kingdom andCanadian jurisdictions with a view on presenting key aspects and measures thatare employed for operating an efficient postmarketing surveillance system inregulated markets.