Post Authorisation Safety Study [PASS]

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 Pharmacovigilance Risk 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.

Glossary: Phase IV Trials
Introduction to medicines
A medicine is commonly defined as a drug or preparation that can treat or prevent disease. Medicines must be delivered into the body, where they are then distributed to the organs that need them before being broken down and excreted.
Research Ethics Committees (REC)
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard operating procedures in order to protect the health and safety of human participants of clinical trials, among other things.
Bioavailability and bioequivalence
Bioavailability is the fraction (percentage) of an administered dose of unchanged drug that reaches the blood stream (systemic circulation). Bioavailability varies between different pharmaceutical ingredients and mode of administration.
Pharmacovigilance: Monitoring the safety of medicines
Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.

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