Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’s (EMA’s) risk management plan (RMP) is to “document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product” and thus to help sponsors plan their PV and risk minimisation strategy. This article, by Dr Prashant Dhanavade from Sciformix, explores the continuously changing regulations and procedures in PV worldwide.