News Archive

MHRA - Consultation Results on ICH E6(R3)

13th May 2025

The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline.

HRA - Clinical trial regulations reform

7th May 2025

The Health Research Authority (HRA) has been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to amend the Medicines for Human Use (Clinical Trials) Regulations 2004.

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HRA - Our work as part of UKCRD to streamline and reform study set-up

7th May 2025

The Department of Health and Social Care (DHSC) has established the UK Clinical Research Delivery (UKCRD) programme, a cross-sector programme of work aimed at creating a faster, more efficient, more accessible and more innovative clinical research delivery system – making the UK a world leader in clinical trials.

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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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