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Home > EU PAS Register

The European Union electronic Register of Post-Authorisation Studies (EU PAS Register)

EU PAS Register Upgrade July 2016

What's new?

 

 

 

The EU PAS Register is a publicly available register of non-interventional post-authorisation studies (PAS).

 

The Register has a focus on observational research, and its purpose is to:

 

  • increase transparency,
  • reduce publication bias,
  • promote the exchange of information and facilitate collaboration among stakeholders, including academia, sponsors and regulatory bodies,
  • ensure compliance with EU pharmacovigilance legislation requirements.

 

EU pharmacovigilance legislation requires the European Medicines Agency (EMA) to make public the protocols and abstracts of results of non-interventional post-authorisation safety studies (PASS) imposed as an obligation of marketing authorisation by a competent authority in accordance with Article 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC. Annex III of the Commission Implementing Regulation (EU) No 520/2012 further specifies that the final report of imposed non-interventional PASS must provide the date of making it public (in EU PAS Register).

 

PASS initiated, managed or financed voluntarily by a marketing authorisation holder and which are required in a Risk Management Plan (RMP) to further investigate safety concerns or to evaluate the effectiveness of risk minimisation activities, and any other PASS should also be entered into the EU PAS Register to support the same level of transparency, scientific and quality standards. Further information about the requirements for the registration of PASS is available in the guideline on Good Pharmacovigilance Practices (GVP) module VIII.

 

Information on post-authorisation efficacy studies (PAES) that are not clinical trials (i.e. outside the scope of Directive 2001/20/EC) should also be entered in the EU PAS Register to support transparency on post-authorisation efficacy studies (PAES), whether they are initiated, managed or financed by a marketing authorisation holder voluntarily or pursuant to an obligation. Further information about the requirements for PAES is available on EMA's Q&A webpage.

 

Go to the EU PAS Register

 

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