Understanding Post-Authorisation Safety Studies (PASS) in Pharmacovigilance

Post-Authorisation Safety Studies (PASS) are conducted after a medicinal product is authorized to gather more safety information or assess risk management effectiveness. These studies evaluate the safety and benefit-risk profile of the product, aiding regulatory decision-making. PASS aims to identify safety hazards, confirm safety profiles, or assess risk management measures. Clinical trials or non-interventional studies may be employed in PASS protocols. Further reading on PASS is available from the European Medicines Agency.

• Pharmacovigilance
• Post-Authorisation Safety Study
• Medicinal Product
• Regulatory Decision-making
• Risk Management

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1. European Patients Academy on Therapeutic Innovation Aspects of pharmacovigilance: Post-Authorisation Safety Studies (PASS)

2. What is a Post-Authorisation Safety Study (PASS)? European Patients Academy on Therapeutic Innovation A PASS is a study carried out after a medicinal product has been authorised, in order to obtain further information on a medicinal product s safety or to measure the effectiveness of risk-management measures The purpose of the PASS is to evaluate the safety and benefit-risk profile of a medicinal product and to support regulatory decision-making The protocols and results of PASSs are assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) 2

3. Scope of a PASS European Patients Academy on Therapeutic Innovation A PASS aims to Identify, characterise, or quantify a safety hazard; Confirm the safety profile of a medicine; or, Measure the effectiveness of risk-management measures. PASSs can either be clinical trials or non-interventional studies. 3

4. Further reading European Patients Academy on Therapeutic Innovation European Medicines Agency (2015). Post-authorisation safety studies (PASS). Retrieved 29 September, 2015 from http://www.ema.europa.eu/ema/index.jsp?curl=pages/re gulation/document_listing/document_listing_000377.jsp& mid=WC0b01ac058066e979 4