Post Authorisation Safety Studies
A post authorisation safety study (PASS) is any study relating to an authorised medicine, carried out with the intention of identifying and quantifying a safety concern, confirming the safety profile of a medicine or measuring the effectiveness of risk minimisation measures.
A PASS may be carried out to provide reassurance about the absence of a safety concern related to a specific adverse reaction, to further investigate known safety concerns or to study the use of the medicine in patients who weren’t included in clinical trials, for example, older patients or pregnant women. A PASS may be conducted voluntarily by a drug company or it may be imposed by a regulatory authority if there are safety concerns with the use of the medicine. PASS studies are closely supervised by regulatory authorities in coordination with the European Medicines Agency (EMA). Study protocols, progress reports and final study results are submitted to the EMA and regulatory authorities for review.