EMA Updated Post-Authorisation Safety Studies (PASS)

The purpose of the information in PASSs is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. They aim to:

• identify, characterise or quantify a safety hazard;
• confirm the safety profile of a medicine, or;
• measure the effectiveness of risk-management measures.

The EMA has updated the section of questions and answers for non-interventional imposed PASS: Revision to Q&A (#2) and a new Q&A (#16).