Post-authorisation safety studies (PASS)

  • Email
  • Help

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 and 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 Agency's Pharmacovigilance Risk Assessment Committee (PRAC) assesses the study protocol and the outcomes of these studies as given in the final study report.

Guidance is available below on the format and content of study protocols and final study reports for non-interventional studies. MAHs have had to follow this guidance, which is based on Commission Implementing Regulation No 520/2012 of 19 June 2012, 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 PASS protocols is available below. Timetables for final study reports are under development.

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, including how to apply, is available in:

Scientific advice on PASS

Starting in July 2015, EMA is launching a 12-month pilot to encourage companies to seek scientific advice for PASSs for medicines. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market. This pilot will build on the expertise of the Agency's Pharmacovigilance Risk Assessment Committee. The main focus of the pilot will be non-imposed PASSs, which are studies that are not a condition to the marketing authorisation.

For more information, see:

Publication of information on PASSs

The Agency publishes the protocols and abstracts of the final study reports of PASSs in the EU post-authorisation study (PAS) register 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 ENCePP Electronic register of studies.

Post-authorisation efficacy studies

A post-authorisation efficacy study (PAES) is a study that aims to clarify the benefits of a medicine on the market including efficacy in everyday medical practice.

For more information on PAES, see Post-authorisation efficacy studies: questions and answers.

Table of contents


Guidance for marketing-authorisation holders

Back to top

Document(s) Language Status First published Last updated Effective Date
Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies (English only)   02/10/2012    
Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies (English only)   28/01/2013 02/08/2013  

Templates for assessors

Back to top

Document(s) Language Status First published Last updated Effective Date
PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template (English only)   11/12/2012 02/07/2015  
Template PRAC assessment report of an non-interventional imposed PASS final study report (English only)   10/02/2014    
Template PRAC assessment report of an non-interventional imposed PASS final study report (English only)   10/02/2014    

Timetables

Back to top

Document(s) Language Status First published Last updated Effective Date
Timetable: Post-authorisation safety study (PASS) protocols (English only)   02/07/2015 26/11/2015 02/07/2015