News Archive

FDA sets out investigator responsibilities for safety reporting in investigational drug and device studies

24th December 2025

The FDA has published draft guidance clarifying what investigators must report, and when, during clinical research involving investigational drugs and devices.

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MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare

24th December 2025

The MHRA is asking the public, clinicians and industry to help shape future rules for AI in healthcare. Link to press release.

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Processes and practices applicable to Bioresearch Monitoring (BIMO) inspections (FDA)

24th December 2025

The FDA has issued final guidance setting out what sponsors and research sites should expect during BIMO inspections, and how to manage inspection communications and records requests.

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Regulation of AI in healthcare – MHRA Call for Evidence

24th December 2025

The MHRA is inviting views on how AI used in healthcare should be regulated, as part of work to shape a new UK framework for AI medical devices.

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Sponsor responsibilities — safety reporting requirements and safety assessment for IND and BA/BE studies

24th December 2025

The FDA has issued guidance setting out how sponsors should assess safety information and submit timely, meaningful safety reports during IND and bioavailability/bioequivalence studies.

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EMA Human Medicines Highlights - December 2025

18th December 2025

Read online now

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Health Institution Exemption for General Medical Devices

18th December 2025

The MHRA has published updated guidance explaining how the Health Institution Exemption (HIE) works for general medical devices used in UK health and care settings.

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MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

18th December 2025

New MHRA guidance helps health institutions safely make or adapt general medical devices for their own patients in Great Britain.

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EMA welcomes political agreement on new EU pharmaceutical legislation

15th December 2025

The European Medicines Agency (EMA) has welcomed a landmark political agreement to reform the EU’s pharmaceutical legislation — the biggest overhaul in more than two decades.

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Good clinical practice for clinical trials – updated December 2025

15th December 2025

The MHRA’s Good Clinical Practice (GCP) guidance for clinical trials in the UK was refreshed on 12 December 2025, clarifying expectations for compliance and inspections.

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