The post-authorization safety study (PASS) is a study conducted after a medicine has been authorized, to draw more information related to the safety of the medicine or to ensure the effectiveness of measures of risk management. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is in charge of evaluating the protocols and results of PASS. The PASS can either be a non-interventional study or a clinical trial.

The purpose of a PASS is to assess the safety and risk-benefit profile of a medicine. It aims at:

  1. Establishing any safety risk
  2. Ensuring a medicine’s safety profile
  3. Evaluating the effectiveness of risk management steps

Non-Interventional PASS

A PASS is considered as non-interventional, if:

  • A medicine is prescribed as per the terms of marketing authorization in the usual way
  • The treatment of a patient is based on the current situation and not the trial protocols
  • Additional monitoring practices are not performed on patients
  • Epidemiological methods are used for data analysis

A non-interventional PASS may be imposed by the EU competent authority as a part of marketing authorization or post-marketing authorization or under special circumstances.

The PASS and The Types

There are two types of PASS

1. Imposed PASS – It is an obligation for Marketing-Authorization Holders (MAH) to carry out imposed PASS. This includes studies which are obligated, specially granted under exceptional circumstances. PRAC can also request companies to carry out some other studies.

2. Voluntary PASS – These studies are carried out by the MAHs without any obligations. Voluntary PASS includes studies which are non-imposed and are required for the risk-management plans.

The PASS is an integral part of marketing authorization in the EU. To ensure that these studies are carried out following necessary GVP standards, consulting a Regulatory expert is advised. For more information related to PASS and other regional studies, reach out to Freyr at