The HMA-EMA Catalogue of RWD studies is replacing the European Union electronic register of post-authorisation studies (EU PAS Register®), which was a publicly available register of non-interventional post-authorisation studies accessible through the ENCePP website.
The catalogue of RWD studies focuses 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.
What type of studies should be added in the study catalogue?
Non-interventional post-authorisation safety studies (PASS) imposed as an obligation of marketing authorisation or as a specific obligation in the framework of a marketing authorisation granted under exceptional circumstances.
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. These should be published by the Marketing Authorisation Holder (MAH) in the EMA-HMA catalogue.
Required non-interventional PASS
MAHs are encouraged to enter in the HMA-EMA Catalogue of RWD studies any PASS initiated, managed and/or financed by themselves and which are required in a Risk Management Plan (RMP) to further investigate safety concerns or to evaluate the effectiveness of risk minimisation activities. Further information about the requirements for the registration of PASS is available in the guideline on Good Pharmacovigilance Practices (GVP) module VIII.
Any other non-interventional study conducted by MAHs, regulators, academia or research organisations
To support the same level of transparency, as well as scientific and quality standards, study sponsors (e.g., MAHs, regulators or research organisations) are encouraged to enter in the EMA-HMA Catalogue study protocols and results/reports of any conducted non-interventional study (not restricted to safety or post-authorisation) that is outside the scope of Regulation (EU) No 536/2014 (i.e., not a clinical trial).
Additional consideration
If there is doubt whether the study is considered interventional or non-interventional, the study sponsor may use the Q&A from Regulation (EU) No 536/2014 to help decide.