News Archive

Get integrated scientific advice from the MHRA and NICE for medicines

23rd February 2026

The MHRA and NICE now offer a joined-up scientific advice service to help medicine developers align regulatory and health technology assessment evidence needs early in development.

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UK medical device testing hits record high as MHRA backs growth in brain and AI technology

19th February 2026

UK medical device testing hits record high as MHRA backs growth in brain and AI technology

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Concept paper on revision of the guidelines on good manufacturing practice for medicinal products - annex 6 manufacture of medicinal gases

18th February 2026

Consultation open: 11/02/2026 to 11/04/2026

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Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation

18th February 2026

Consultation dates: 09/02/2026 to 09/04/2026

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EMA CVMP Meeting Highlights — 10–12 February 2026

18th February 2026

he European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) published outcomes from its February 2026 plenary meeting, covering new product opinions, variations, pharmacovigilance updates and draft guidance.

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EMA PRAC Meeting Highlights — 9–12 February 2026

18th February 2026

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a major safety review and issued key risk-management recommendations for human medicines.

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Global commitment on display as countries negotiate key annex to the Pandemic Agreement

18th February 2026

WHO Member States have shown strong unity in advancing negotiations on a critical annex to the global Pandemic Agreement aimed at improving pandemic preparedness and equity.

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Medical Devices Regulations – Targeted Consultation on the Indefinite Recognition of CE-Marked Devices

18th February 2026

The MHRA is consulting on proposals to allow CE-marked medical devices to be recognised indefinitely in Great Britain.

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Mock example developed to illustrate quality modules of ICH M4Q (R2) Common Technical Document

18th February 2026

The International Council for Harmonisation (ICH) has published a mock example to help stakeholders understand the revised quality modules in the updated CTD guideline.

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Timelines for acceptance of CE-marked medical devices in Great Britain (GB)

18th February 2026

MHRA has published expected timelines for when CE-marked medical devices and IVDs can continue to be accepted in Great Britain.

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