Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Do you wish to register a study in the EU PAS Register?

Are you considering applying for an ENCePP study seal?

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

DARWIN EU open call for expression of interest for new data partners

EMA is looking for new data partners to collaborate with DARWIN EU® - the Data Analysis and Real-World Interrogation Network. Public or private institutions that have access to real-world healthcare data can submit an expression of interest to become a potential new data partner in DARWIN EU. The data will be used for studies to generate real-world evidence that will support scientific evaluations and regulatory decision making on medicines in the EU.

Deadline for expression of interest: 31 October 2023

Information on how to express your interest is available on the DARWIN EU Coordination Centre website.

11^th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

The 11^th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published, in collaboration between EMA and the ENCePP Research Standards and Guidance Working Group.

The structure of the Guide has been revisited to better illustrate the evidence generation flow and to increase the emphasis on important methodology. Besides the update of several chapters, some have been revised to reflect a fast changing environment: Chapter 9 on Research networks for multi-database studies addresses the expansion and use of DARWIN EU®, and Chapters 16.1 on Comparative effectiveness research, 16.5 on Artificial intelligence, and 16.6 on Real-world evidence (RWE) and pharmacoepidemiology, have been extensively revised.

New recommendations, to foster transparency and high quality of non-interventional studies, and to facilitate their assessment, include the use of the causal inference target trial emulation approach and the estimand framework, and the use of the HARPER protocol template.

The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in sound pharmacoepidemiological research, including drawing lessons from the COVID-19 pandemic and addressing new methodological challenges.

This 11^th Revision of the Guide continues to provide a useful resource for researchers, regulators, and marketing authorisation holders and applicants.

EU PAS Register downtime on 17 June 2023

The EU PAS Register will be unavailable on Saturday, 17 June 2023 from 8.00 to 16.00 due to essential maintenance work. The system will run as normal after 16.00.

Related information: EU PAS Register

DARWIN EU® call for new data partners

DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines. 

The network will onboard ten additional data partners this year. The DARWIN EU® Coordination Centre, in collaboration with EMA, has launched an open call for expression of interest from potential data partners. Interested data partners are invited to visit the www.darwin-eu.org website for further information.

Related information: EMA news announcement

28 February 2023

EU PAS Register and ENCePP Resources Database migration plans to new electronic catalogues

In May 2022, the HMA-EMA Big Data Steering group published the first version of a list of metadata elements describing real-world data sources and studies to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

The European medicines regulatory network is working to develop a new electronic public catalogue of data sources and studies based on the above-mentioned list of metadata. This new catalogue will replace and enhance the current ENCePP Resources Database and the EU PAS Register, improving this way data discoverability by means of providing improved catalogue search features on a wider set of metadata. The new catalogue will facilitate researchers in discovering the most suitable data sources for their studies and it will support the assessment of study protocols and study results. Also, it aims at providing higher interoperability between studies and data sources.

The new catalogues and metadata list represent the implementations of one of the ten priority recommendations set by the joint the HMA-EMA Big Data Task Force in 2020, which is “Data discoverability”. This priority is being accomplished by a set of relevant deliverables outlined in the revised Big Data Steering Group workplan 2022-2025.

In this context, the EMA is planning to migrate the resources indexed in the ENCePP Resources Database and the EU PAS Register to the new catalogue. The Agency has sent dedicated emails to the contact points of the data sources already included in the ENCePP Resource Database in order to get support for the update and completion of the records in accordance with the new metadata list, that will feed into the new catalogues.

Related information: Big data | European Medicines Agency (europa.eu)

ENCePP 2022 Activity Report published

The annual report covers the full list of activities performed in 2022, as well as statistics on the ENCePP Guide, the ENCePP website and the EU PAS Register.

Related information: ENCePP 2022 Activity Report