News Archive

FDA expands artificial-intelligence capabilities with “agentic” AI deployment

2nd December 2025

The U.S. Food and Drug Administration (FDA) has rolled out “agentic AI” to support staff across the agency — marking a major step in its internal AI rollout.

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ICH Assembly Meeting, Singapore — November 2025

2nd December 2025

The International Council for Harmonisation (ICH) held its 2025 Assembly in Singapore, completing major guideline decisions and welcoming new members.

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International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers

2nd December 2025

ICH expands its global regulatory network by admitting new members and observers during its November 2025 meeting.

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Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025

2nd December 2025

The EMA’s PRAC met 24–27 November to review safety-related issues for authorised medicines — concluding no new referral procedures, but continuing ongoing assessments and routine pharmacovigilance tasks.

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New MHRA-supported research reveals patterns of vaccine-derived poliovirus spread

2nd December 2025

A major study offers new insight into how vaccine-derived poliovirus type 2 spreads and what this means for global eradication.

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Innovative approaches to Med Tech regulatory reform

28th November 2025

The MHRA sets out new steps to modernise the UK’s medical technology regulatory framework.

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Insurance Review in Phase 1 Clinical Trials

28th November 2025

The MHRA Inspectorate clarifies updated insurance requirements for Phase 1 clinical trials ahead of the 2026 regulations.

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MHRA Strategy Blog Series

20th November 2025

The MHRA has launched a strategy blog series bringing together external voices to discuss the future direction of UK medicines and medical devices regulation.

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Professor Alastair Denniston: The future regulation of AI in healthcare

20th November 2025

Professor Alastair Denniston sets out core principles for a new UK framework to regulate AI in healthcare so it is safe, fast and trusted.

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EMA CHMP Meeting Highlights – 10-13 November 2025

19th November 2025

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval and four extensions of indication at its November 2025 session.

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