Post-authorisation safety studies (PASS)

A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results.

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.

PASSs can either be clinical trials or non-interventional studies.

Imposed or voluntary PASSs

PASSs are either imposed or voluntary.

Marketing-authorisation holders (MAHs) are obliged to carry out imposed PASSs. These include studies that are a specific obligation for a marketing authorisation granted under exceptional circumstances and other studies that the PRAC requests the company carry out.

Voluntary PASSs are sponsored or conducted by MAHs on their own initiative. They include non-imposed studies that are requested in risk management plans.

Assessment of imposed PASSs

For imposed PASSs, the PRAC assesses the study protocol and the outcomes of these studies as given in the final study report.

EMA has published guidance on the format and content of study protocols and final study reports for non-interventional studies, together with the PRAC assessment report templates.

Study protocols:

Final study reports:

The guidance is based on Commission Implementing Regulation No 520/2012 of 19 June 2012. MAHs have to follow the guidance since January 2013.

For clinical trials, MAHs should follow the instructions in volume 10 of the rules governing medicinal products in the European Union (EU).

The timetable for the submission and assessment of imposed non-interventional PASS protocols is available below:

The Agency recommends that companies submit protocols and study reports in the same manner for voluntary PASSs, although this is not mandatory.

Further guidance on PASSs is available in:

Publication of information on PASSs

The Agency publishes the protocols, abstracts and final study reports of PASSs in the EU post-authorisation study (PAS) register hosted on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website.

To enable this publication to take place, MAHs should register their PASSs in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register).

Non-interventional imposed PASS: questions and answers


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