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News Archive

Strengthening collaboration between the MHRA and the Department of Health Northern Ireland

11th December 2025

The MHRA and Northern Ireland partners have agreed a new programme of collaboration to support innovation and patient safety.

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EMA Veterinary Newsletter

9th December 2025

December 2025

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GCP Regulatory News

9th December 2025

The GCP Committee have put together some news from the past quarter.

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CTIS Change Management Survey

4th December 2025

Extended deadline 16 January 2026

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Centres of Excellence for Regulatory Science and Innovation (CERSIs)

4th December 2025

The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.

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Get regulatory advice from MHRA — Medical Devices

4th December 2025

MHRA offers formal “regulatory advice” to help device developers and manufacturers understand how UK medical-device regulations apply to their products.

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Landmark UK–US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses

4th December 2025

The UK and US have struck a new trade agreement that removes tariffs on UK medicines exports to the US, aiming to boost investment and improve access to new treatments.

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EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation

2nd December 2025

The EDQM has released a draft update to its guideline on revising and renewing Certificates of Suitability (CEPs) to the European Pharmacopoeia (Ph. Eur.) — and is now inviting public consultation.

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EMA Human Medicines Highlights

2nd December 2025

November 2025 Edition out now

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FDA Drafts Guidance on Where to Submit Cross-Center Master Files

2nd December 2025

The U.S. Food and Drug Administration (FDA) has issued draft recommendations clarifying which centre should host “cross-centre” Master Files (MFs) when they support multiple product types.

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