News Archive

EMA - Clinical Trials Highlights July 2025

23rd July 2025

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

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MHRA - Medicines and Medical Devices Act 2021 – Stakeholder survey - Open Call for Evidence

23rd July 2025

MHRA invites feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. This call for evidence closes at 11:59pm on 19 September 2025

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EC - Stakeholders’ Consultation on EudraLex Volume 4

8th July 2025

Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities.

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MHRA - Medical devices: Standardised format for the periodic safety update report

4th July 2025

New guidance

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EDQM - 182nd session

3rd July 2025

The European Pharmacopoeia Commission (EPC) held its 182nd session on 17 and 18 June 2025.

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ICH - ICH E20 Draft Guideline Available

3rd July 2025

The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has entered public consultation stage.

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MHRA - Decentralised Manufacturing Regulations Update Webinar

3rd July 2025

Video added. Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on Tuesday 17 June 2025

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MHRA - Decentralised Manufacturing Regulations Update Webinar

3rd July 2025

Video added. Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on Tuesday 17 June 2025

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HRA Blog - Information governance in research

1st July 2025

Blog post by Matthew Sanderson, Research Regulation Specialist

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MHRA - AI Airlock, CERSIs and a new global AI network for health regulators

1st July 2025

Med Tech Regs blog, June 2025: A focus on Software and AI.

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