EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues

As the role of real-world data (RWD) and real-world evidence (RWE) grows in drug development, regulatory decision-making, and post-marketing surveillance, the need for structured, discoverable, and reliable data sources becomes critical. Recognizing this, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) created the HMA-EMA Catalogues of Real-World Data Sources and Studies.

The user guide, updated in June 2025, serves as a blueprint for data holders, researchers, and regulators aiming to contribute to or extract value from this catalogue ecosystem.

The HMA-EMA Catalogues serve two main functions:

• Catalogue of RWD Sources: Helps identify existing data repositories—registries, claims databases, electronic health records—that meet regulatory or research needs.

• Catalogue of RWD Studies: Tracks and documents observational and non-interventional studies using these sources, enhancing transparency and reducing duplication.

These catalogues are critical tools for improving data discoverability, reproducibility, and regulatory collaboration.

The User Guide (Version 2.0) details:

• How to register data sources and studies

• Standardized metadata elements and definitions

• Navigation tips for the RWD Catalogues website

• Validation and submission protocols

Data Source Catalogue: What Information Is Captured?

• Administrative Details: Name, acronym, data holder, contact details, country, language, regions covered, establishment dates, and website links.

• Data Elements Collected:

  • Disease focus (including rare diseases), patient demographics (e.g., pregnancy, neonates), hospital admissions, ICU stays, cause of death, prescriptions, dispensing, advanced therapy medicinal products, contraception, indications, medical devices, vaccines, procedures, clinical measurements, healthcare provider details, and genetic data.

• Quantitative Descriptors: Size of the dataset, frequency of updates, and population coverage.

• Data Flows and Management: How data is collected, processed, and accessed, including privacy and security measures.

• Financial Support and Qualification: Funding sources and any formal data source qualifications (e.g., EMA or ISO certification).

Data Study Catalogue: What Information Is Captured?

• Administrative Details: Study title, sponsor, principal investigator, and participating institutions.

• Methodological Aspects: Study design, objectives, population, endpoints, and statistical methods.

• Data Management: Data collection, storage, quality control, and privacy measures.

• Resources: Funding, personnel, and infrastructure used.

Registering, Validating, and Maintaining Records

• Registering a Data Source or Study: Submit detailed metadata through the online platform. The guide provides step-by-step instructions for entering information, adding co-authors, and submitting for approval.

• Validation and Publication: Entries undergo validation by the catalogue administrators before being published. Submitters are notified of any required revisions.

• Ongoing Maintenance: Data holders and investigators are responsible for keeping records up to date, including contact information and data content changes.

Navigating the RWD Catalogues Website

• User Dashboard: Manage your submissions, track approval status, and update records.

• Adding and Submitting Records: Guided forms ensure all required fields are completed. Submissions can be saved as drafts and edited before final submission.

• Collaboration and Revision Logs:Add co-authors, accept collaboration requests, and view the history of changes to each record.

• Exporting and Downloading Data: Users can search, filter, and export records for further analysis.

• Subscription and Notifications: Subscribe to updates on specific studies or data sources to stay informed of changes.

By standardizing the way RWD is catalogued and accessed, these tools help ensure that regulatory decisions are informed by the best available evidence. For more detailed instructions and to access the catalogues, refer to the official user guide (PDF).

Additional EMA Guidance Summaries

• Reflection Paper on Real-World Data in Non-Interventional Studies: This paper discusses best practices and regulatory expectations for generating real-world evidence from non-interventional studies. It emphasizes data quality, transparency, and the need for robust methodologies to ensure that RWD can reliably support regulatory decisions. Read more

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• Concept Paper on Clinical Investigation for Systemic Sclerosis Treatments: This concept paper outlines the EMA’s intent to develop new guidance for clinical trials in systemic sclerosis, focusing on harmonizing endpoints, study designs, and regulatory requirements to improve drug development in this challenging therapeutic area. Read more

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• SEND Proof-of-Concept Q&A for Industry: This document answers industry questions about the SEND (Standard for Exchange of Nonclinical Data) proof-of-concept project, clarifying the scope, participation terms, and data submission processes for nonclinical regulatory submissions. Read more