EMA’s User Guide: HMA-EMA Catalogues of Real-World Data Sources and Studies

The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and public health. Recognising the growing importance of RWD, the European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA), has published the User Guide of the HMA-EMA Catalogues of Real-World Data Sources and Studies (Version 2.0, June 2025).

What Are the HMA-EMA RWD Catalogues?

The HMA-EMA Catalogues are centralized, searchable databases designed to:

• Catalogue real-world data sources (such as registries, electronic health records, and claims databases) across Europe.

• Catalogue real-world data studies (including observational studies, pragmatic trials, and post-authorisation safety studies).

These catalogues support transparency, facilitate collaboration, and help researchers and regulators identify suitable data sources and studies for regulatory and scientific purposes.

The guide is intended for:

• Data holders wishing to register their data sources.

• Investigators submitting study records.

• Regulators, researchers, and other stakeholders are seeking to use the catalogues to identify relevant RWD sources for regulatory or research purposes.

It provides definitions, data field descriptions, and step-by-step instructions for submitting and maintaining records.

The guide details the metadata required to describe each data source, including:

• Administrative details: Name, acronym, data holder, contact information, countries and regions covered, language, and website.

• Content characteristics: Whether the data source focuses on specific diseases, rare diseases, pregnancy/neonates, hospital admissions, ICU admissions, cause of death, prescriptions, dispensing, advanced therapy medicinal products (ATMPs), contraception, medical devices, vaccines, procedures, clinical measurements, healthcare provider data, and genetic data.

• Quantitative descriptors: Size of the data source, number of records, and population covered.

• Data flows and management: How data is collected, processed, and updated; data privacy and governance.

The guide provides clear instructions on:

• How to register a new data source or study: Including the validation and publication process.

• How to update or maintain records: Ensuring the catalogue remains current and reliable.

• Registering institutions and networks: Facilitating collaboration and recognition of data holders.

• Also includes practical tips for:

  • Logging in and using the dashboard

  • Adding and submitting records for approval

  • Collaborating with co-authors

  • Using the revision log and downloading records

  • Searching and exporting results

Why Are These Catalogues Important?

• Facilitate regulatory science by enabling the identification of high-quality RWD sources for drug safety, effectiveness, and health outcomes research.

• Support transparency and collaboration across the European medicines ecosystem.

• Accelerate evidence generation for regulatory submissions, health technology assessments, and public health policy.

For more details, refer to the official user guide here: User guide of the HMA-EMA Catalogues of real-world data sources and studies.