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.
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:
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.
The HMA-EMA Big Data Steering Group reviews the list of metadata annually, based on feedback from catalogue users.
A draft good practice guide is also available to help users of the catalogues.
By end of 2024, EMA intends to publish a revised version addressing feedback from a public consultation. Separate sections will cover how to use the catalogues to identify and assess the suitability of data sources, and definitions and descriptions of the metadata list.
All European data holders, marketing authorisation holders, networks, researchers and institutions interested in having their data used for medicines regulation, or mandated by policy on non-interventional post-authorisation safety studies (PASS), are encouraged to use these catalogues.
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 guidance builds on EMA's experience in using real-world evidence to support regulatory decision-making, described in the report below.
The report is based on studies EMA conducted between September 2021 and February 2023. It focused on:
A list of research topics and a portfolio of use cases are also included in this report.
It is overseen by the EMA-HMA Big Data Steering Group.
It is also part of the European medicines regulatory network's efforts to enable the use of real-world evidence and establish its value across regulatory areas by 2025.
Read EMA report on real-world evidence
Key findings include:
For more information, see:
A reflection paper on non-interventional studies that use real-world data in order to generate real-world evidence for regulatory purposes is available for public consultation.
It is aimed at all stakeholders involved in the planning, conduct and analysis of this type of non-interventional studies, including marketing authorisation holders and applicants.
A non-interventional study is a clinical study that does not meet any of the conditions defining a clinical trial in Article 2.2(2) of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.
The public consultation runs from 3 May to 31 August 2024.
You can contribute by completing the survey below:
For more information on this draft reflection paper, see:
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: