Validation, Publication, and Maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues

1:1

The purpose of this SOP is to describe the steps and procedures concerning the validation, publication, and maintenance of data sources and studies within the HMA-EMA Catalogues of real-world data (RWD) sources and studies. The principles and activities described will apply specifically to EMA staff responsible for the validation of the Catalogues’ content. The same principles will apply to the Catalogues’ users when submitting entries.

Acces this publication (pdf)
European Medicines Agency (EMA)

Year of publication

2025

ISBN

SOP/TDA/3543; EMA/467789/2024

Source

European Medicines Agency (EMA)

Author

European Medicines Agency (EMA)

You might also be interested in

RealiseD webinars

RealiseD Webinar Series: Helping re‑shape rare disease clinical trials

13 January – 10 February 2026 | Online webinar series to advance best practices in clinical trial design for rare and ultra rare diseases.
P065130-367547

AFM‑Telethon launches its 2026 call to fund scientific and medical research in neuromuscular disorders

A funding opportunity for neuromuscular and rare genetic disease research is now open
Non-human primate hand via pickpik.com (CC0)

EMA public consultation on non‑human primate use in safety testing

EMA seeks stakeholder input on new reflection paper to reduce and replace non‑human primate use in medicines safety testing through 3Rs approaches.
abstract publication image on science health

Tailored antisense oligonucleotides for ultrarare CNS diseases: An experience-based best practice framework for individual patient evaluation

Outside traditional drug development pathways, clinicians and scientists face the challenge of systematically evaluating whether individual patients with severe ultrarare diseases might be eligible for and potentially benefit from individualized mutation-specific RNA therapies.

ERDERA's

search form