News Archive

EMA - New guidance for HMA-EMA Catalogues of real-world data sources and studies published

29th April 2025

We are pleased to inform you about the publication of new guidance that provide valuable insights on best practices for the users of the HMA-EMA Catalogues of real-world data sources and studies (RWD Catalogues): Good practice guide - provides regulators, researchers and other stakeholders with recommendations on effectively using the Catalogues to identify and assess the suitability of data sources for studies on the use, safety, and effectiveness of medicines. The guide underwent public consultation and has been adopted by the Methodology Working Party and the Committee for Medicinal Products for Human Use (CHMP). A new user guide - primarily aimed at users creating data records in the Catalogues, this guide includes detailed instructions on submitting and maintaining records, along with descriptions of the metadata fields. Updated list of metadata elements - includes an improved description of data sources and study records based on users’ feedback. The RWD Catalogues, which were launched a year ago, enhance transparency and access to real-world data for research and regulatory purposes. They serve two key roles: Open access resource: the Catalogues allow for the pre-registration of RWD studies in Europe and beyond, promoting transparency and reproducibility. Data sources hub: they act as a central resource for regulators, companies, and researchers to identify suitable data sources to investigate the use, safety, and effectiveness of medicines. Since their launch in February 2024, the Catalogues have steadily grown, now featuring 3053 registered studies and 246 data sources. Researchers can add information about their studies in the Catalogues following this link: Catalogue of RWD studies. Data holders can add information about their data source in the Catalogues following this link: Catalogue of RWD sources. More information: Real-world evidence | European Medicines Agency (EMA)

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MHRA - MHRA Licensing – National assessment procedure for medicines webinar

29th April 2025

6th May 2025

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EMA - Clinical Trials Highlights April 2025

23rd April 2025

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU

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EMA - ICH Q1 Draft Guideline & Step 2

23rd April 2025

Presentation Now Available on the ICH Website

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EMA - GMP Q&A Updated

16th April 2025

EMA has published updated GMP Q&A's.

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025

16th April 2025

Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025

16th April 2025

PRAC carried out its broad range of responsibilities for managing the risks associated with medicine use

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EMA/HMA - Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

16th April 2025

EMA and HMA encourage strengthening Europe’s production capacity

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MHRA - Risk minimisation measures for medicines Guidance

16th April 2025

Guidance for healthcare professionals on risk minimisation options for medicines.

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MHRA Blog - MedTech regulatory reform and the importance of partnerships

16th April 2025

Medical technologies will play a critical role in delivering the government’s 10 Year Health Plan and its three shifts: hospital to community; analogue to digital; and sickness to prevention.

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