The European Medicines Agency (EMA) and the European medicines regulatory network are working to establish a sustainable framework enabling better integration of real-world data and real-world evidence into regulatory decisions.
For more information, see:
EMA has established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of human medicines, including vaccines, from real-world healthcare databases across the European Union (EU).
This capability is called the Data Analysis and Real World Interrogation Network (Darwin EU).
For more information, see:
A guide is available on how EMA can help generate real-world evidence.
It is meant for EU regulators and decision-makers, including EMA's scientific committees, working parties and groups, as well as national competent authorities, healthcare technology assessment bodies and payers.
It covers:
EMA cannot consider requests from other bodies and institutions, including academia, pharmaceutical companies and contract research organisations.
The guide builds on EMA's experience in using real-world evidence to support regulatory decision-making, described in the report below.
A third report based on studies EMA conducted using real-world data between February 2024 and February 2025 is now published.
It summarises the progress made to enable the use of real-world data and establish its value in regulatory decision-making.
A list of research topics and a portfolio of use cases are also available in the report.
Read third report
The studies included in this report addressed the following research questions:
Highlights include:
For more information, see:
Find below information on the previous EMA real-world evidence reports covering the period from September 2021 to February 2024.
Select the expandable panels to read the complete reports.
Two online catalogues are available from HMA and EMA, one for real-world data sources and one for real-world data studies:
The catalogues serve to:
They enhance and replace two databases previously maintained by EMA:
| Catalogue | Discontinued database |
|---|---|
| Real-word data sources | European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) catalogue |
| Real-world data studies | European Union electronic register of post-authorisation studies (EU PAS Register) |
The catalogues use an agreed list of metadata to describe and connect data sources to studies, using ‘FAIR’ (Findable, Accessible, Interoperable and Reusable) data principles. EMA reviews and updates the list of metadata periodically, based on feedback from catalogue users.
The following documents are also available to support users of the catalogues:
A good practice guide which provides regulators, researchers and other stakeholders with recommendations on how to use the catalogues effectively to identify and assess the suitability of data sources.
A document summarising the outcome of the public consultation on the good practice guide is also available below.
A user guide that supports users submitting data to the catalogues. It provides descriptions of the data fields and definitions, as well as guidance on how to submit and maintain records in the catalogues. EMA updates it periodically to reflect changes in the list of metadata.
EMA encourages all stakeholders to use these catalogues if they are interested in having their data:
Stakeholders include:
EMA has developed a roadmap to produce guidance on real-world evidence to support regulatory decision-making.
A document describing the roadmap and the journey that led to it is available below.
It includes a review of existing real-world evidence guidance that regulators have issued. It also proposes topics for further guidance development.
A reflection paper on non-interventional studies that use real-world data to generate real-world evidence for regulatory purposes is available.
It is relevant for all stakeholders involved in the planning, conduct and analysis of this type of non-interventional studies. This includes marketing authorisation holders and applicants.
The reflection paper was available for public consultation between May and August 2024.
Guidance is available on the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making:
EMA works to help integrate real-world evidence into regulatory decision-making across the world, within the International Coalition of Medicines Regulatory Authorities (ICMRA).
In June 2022, ICMRA held a workshop enabling regulators to share experience in obtaining and using real-world evidence for the assessment of medicines. In July 2022, it also issued a pledge to foster global efforts in this area.
For more information, see:
A reflection paper is available aiming to harmonise real-world evidence terminology and optimise the use of real-world data to support regulatory decision-making.
For more information, see: