A Post-Authorisation Safety Study (PASS) is a study conducted after a medicinal product has been authorized to further investigate a specific safety risk or to confirm the safety of the product under real-world conditions. Such studies may be initiated voluntarily by the marketing authorization holder or mandated by health authorities (such as the EMA) as a condition of the authorization or as part of the risk management plan (RMP).
A PASS can be designed as an interventional clinical trial or as a non-interventional study (NIS). Its objective is to generate new safety information, identify rare adverse effects, quantify risk factors, or evaluate the effectiveness of risk minimization measures. For CROs, conducting PASS is a vital component of pharmacovigilance services, helping to monitor a drug’s benefit-risk profile throughout its entire life cycle.