The publicly availabe register referred to as the 'EU PAS Register' in Good Pharmacovigilance Practices (GVP) is to be maintained by the European Medicines Agency (EMA).
The E-Register of Studies de facto serves as the 'EU PAS Register' for all pharmacoepidemiological and pharmacovigilance studies regardless of whether they are initiated, managed or financed by a marketing authorisation holder, or whether they are conducted by a research centre that is a partner of the ENCePP network or any other research centre, including from outside the European Union.
Marketing authorisation holders should register all non-interventional post-authorisation safety studies (PASS) relating to medicines in the ENCePP E-Register of Studies.
The pharmacovigilance legislation requires the EMA to publish in a publicly available register the protocols and abstracts of results of PASS imposed as an obligation by a competent authority in accordance with Articles 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC. It also specifies that the final report of such studies must provide the date of registration in this register.
Information about PASS which are initiated, managed or financed voluntarily by a MAH and which are required in the Risk Management Plan (RMP) to further investigate safety concerns or to evaluate the effectiveness of risk minimisation activities, or any other PASS should also be entered into this register in order 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, chapter VIII.B.4.
To register a study, go to the ENCePP E-Register of Studies.