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EU | EMA 2025 Vision for the Regulatory Use of RWE – Connecting the Pieces

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In the past 12 months, the EMA has been busy…publishing strategies and frameworks, creating coordination centres, and requesting proposals from training vendors! The question is…how does this all fit together?

Here we provide a a high-level overview of what has happened and what role each of the activities plays in helping to realise the EMA’s 2025 vision for the use of RWE in regulatory decision making.

DECEMBER 2022 – The European Medicines Agency (EMA) has a very ambitious goal for the use of real-world evidence (RWE):

“…by 2025 the use of real-world evidence will have been enabled and the value will have been established across the spectrum of regulatory use cases”

[EMA – A vision for use of real-world evidence in EU medicines regulation (24 November 2021)] [ref 1]

In the past 12 months, the EMA has been busy…publishing strategies and frameworks, creating coordination centres, and requesting proposals from training vendors! The question is…how does this all fit together?  The following image provides a high-level overview of what has happened and what role each of the activities plays in helping to realise the EMA’s 2025 vision for the use of RWE in regulatory decision making…exciting times!


DECEMBER 2021 = EMA – Data Standardisation Strategy [ref 2]

      • The European medicines regulatory network’s data standardisation strategy sets out principles to guide the definition, adoption and implementation of international data standards by the network.
      • It aims to:
        • enable quicker uptake of international data standards across the EU
        • improve data quality
        • enable data linkage and data analysis to support medicine regulation

FEBRUARY 2022 = EMA – Data Analysis and Real World Interrogation Network (DARWIN EU®) [ref 3] [ref 4]

      • In February 2022, EMA selected a service provider (Erasmus University Medical Center Rotterdam) to deliver DARWIN EU
      • By 2024, DARWIN EU will be fully operational with involvement of data partners and medicine regulators
      • The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product
      • The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.
      • By supporting decision-making on the development, authorisation and surveillance of medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry. Additionally, DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.
      • For example, the availability of timely and reliable real-world evidence can lead to innovative medicines becoming more quickly available to patients. Better evidence also supports more informed regulatory decision-making on the safe and effective use by patients of medicines on the market.  

APRIL 2022 = EMA – Big Data Training Tender – Pharmacoepidemiology and Read-world Evidence curriculum 

The Pharmacoepidemiology and Read-world Evidence curriculum (Lot 2) aims at training regulators and scientists for the collection, analysis, interpretation, and use of observational/real-world data for regulatory evaluation and decision-making on medicinal products. Upon completion of the curriculum, training participants should have a good understanding of the pharmacoepidemiological and real-world evidence concepts and methods to develop, analyse and critically review protocols and reports of non-interventional studies.

MAY 2022 = European Commission – European Health Data Space (EHDS) Proposal [ref 5]

      • Proposal for a European Health Data Space published in May 2022
      • Planned to be effective (in force) by 2025
      • Implements a European electronica health record (EHR) exchange format
      • MyHealth@EU = Empowers individuals through increased digital access to and control of their electronic personal health data, nationally and cross-borders, as well as support to their free movement, fostering a genuine single market for electronic health record systems, relevant medical devices and high-risk artificial intelligence (AI) systems (primary use of data)
      • HealthData@EU = Provides a consistent, trustworthy, and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data)

JUNE 2022 = EMA – Metadata List Describing Real World Data [ref 6]

A list of metadata describing real-world data sources and studies is available to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

      • This metadata list will feed into two future EU catalogues on real-world data sources and studies:
        • The catalogue of data sources will cover information on real-world databases, and is due to replace the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) catalogue in late 2023
        • The catalogue of studies will cover studies performed on the data sources, enhancing and replacing the European Union electronic register of post-authorisation studies (EU PAS Register)

JULY 2022 = EMA – Global Regulators Call for International Collaboration to Integrate Real-World Evidence into Regulatory Decision-Making [ref 7]

      • EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).
      • The use of real-world data and real-world evidence in the development, authorisation and monitoring of medicines to support regulatory decision-making is rapidly increasing. Although real-world evidence can play an important role in bridging knowledge gaps, there are still challenges that need to be addressed, such as heterogeneous data sources across the globe and different levels of quality of the data. Interested parties also need to deal with various processes for data sharing and access.
      • During the COVID-19 pandemic, international medicines regulators and researchers have worked together to establish or reinforce collaboration allowing efficient sharing of data and experience in relation to real-world evidence. They agreed to further such collaboration beyond the pandemic.
      • In their statement, ICMRA members pledge to foster global efforts and further enable the integration of real-world evidence into regulatory decision-making. They identify four focus areas for regulatory cooperation:
        • harmonisation of terminologies for real-world data and real-world evidence
        • regulatory convergence on real-world data and real-world evidence guidance and best practice
        • readiness to address public health challenges and emerging health threats; and
        • transparency

SEPTEMBER 2022 = EMA – A Good Practice Guide for the Use of Real-World Metadata [ref 8] [ref 9]

      • This draft guide aims to help regulators, data holders, researchers, pharmaceutical companies, and other interested stakeholders to use the catalogue of data sources that will replace the currently available ENCePP catalogue.
      • For instance, it provides recommendations on how to identify suitable real-world data sources for studies and describes the required metadata elements.
      • Suggestions for consideration received from industry included:
        • Link and cross-reference the Good Practice Guide with the Data Quality Framework to ensure consistency in the use of concepts (i.e., data quality, data reliability) and terminology
        • Clarify the document’s scope from the geographical (EU vs non-EU) and data source type perspectives
        • Add explanations of the metadata and proposed values for key variables and consider additional metadata such as time lag between the collection and availability of data, more granular detail on laboratory data and inclusion of genomic data sources
        • Consider linking the catalogue to similar initiatives such as EHDEN or EHDS catalogues to harmonise definitions and avoid duplication of effort in providing information to different sources from the data holder point of view

OCTOBER 2022 = EMA – Data Quality Framework for EU Medicine Regulation [ref 10]

      • A draft data quality framework for medicine regulation was available for public consultation until 18 November 2022. 
      • The purpose of this framework was to be applicable for any type of human and veterinary data that might be submitted to medicines regulator. The work will continue next year to apply data quality principles outlined in the framework to specific domains (e.g. real-world, manufacturing etc.) and to ensure alignment with developments coming from the European Health Data Space.
      • This guidance document sets out the criteria for a more consistent and standardised approach to the quality of data used in medicine regulation to support benefit-risk decisions. 
      • RWD quality should be considered in terms of (1) Relevance, (2) Reliability, (3) Extensiveness, (4) Coherence, and (5) Timeliness

NOVEMBER 2022 = EMA – DARWIN EU Data Partners Onboarded [ref 11] [ref 12]

In November 2022, DARWIN EU completed the onboarding of the first set of data partners with access to real-world healthcare data from sources such as hospitals, primary care, health insurance, registries and biobanks.


1. EMA – A vision for use of real-world evidence in EU medicines regulation (24 November 2021)


2. EMA – Data Standardisation Strategy [17 Dec 2021]


3. EMA – Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU


4. EMA – Data Analysis and Real World Interrogation Network (DARWIN EU) 


5. European Commission – Proposal for a regulation – The European Health Data Space (May 2022)


6. EMA – Metadata List Describing Real World Data [10 June 2022]


7. EMA – Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making [22 Jul 2022]


8. EMA – A Good Practice Guide for the Use of Real-World Metadata [27 Sept 2022]


9. EMA Report from the Second bi-annual Big Data Steering Group and industry stakeholders meeting [3 Nov 2022]


10. EMA – Data quality framework for EU medicine regulation [10 Oct 2022]


11. Data Analysis and Real World Interrogation Network (DARWIN EU®) 


12. Data Analysis and Real World Interrogation Network (DARWIN EU®) – Data Partners


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