A post authorisation safety study is a study carried out after a medicine has been given a marketing authorisation. Its purpose is to obtain further safety information or to assess how well risk-management measures are working. The information from a post authorisation safety study is used in regulatory decision making.
A post authorisation safety study might be a clinical trial or a non-interventional study, and can be created voluntarily by the MAH, or can be required by the regulator (imposed™). The PharmacovigilanceRisk Assessment Committee (PRAC) at the European Medicines Agency (EMA) is responsible for assessing the protocols of imposed studies and for assessing the studies™ results. The EMA publishes the protocols and abstracts of the final study reports online.