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News Archive
CTIS Change Management Survey
4th December 2025Extended deadline 16 January 2026
Centres of Excellence for Regulatory Science and Innovation (CERSIs)
4th December 2025The MHRA has launched a UK-wide network of Centres of Excellence to advance regulatory science and bring innovative treatments to patients sooner.
Get regulatory advice from MHRA — Medical Devices
4th December 2025MHRA offers formal “regulatory advice” to help device developers and manufacturers understand how UK medical-device regulations apply to their products.
Landmark UK–US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses
4th December 2025The 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.
EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation
2nd December 2025The 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.
EMA Human Medicines Highlights
2nd December 2025November 2025 Edition out now
FDA Drafts Guidance on Where to Submit Cross-Center Master Files
2nd December 2025The 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.
FDA Issues New Guidance on CGMP for Medical Gases
2nd December 2025The Food and Drug Administration (FDA) has published a draft guidance to support the implementation of updated manufacturing rules for medical gases.
FDA expands artificial-intelligence capabilities with “agentic” AI deployment
2nd December 2025The 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.
ICH Assembly Meeting, Singapore — November 2025
2nd December 2025The International Council for Harmonisation (ICH) held its 2025 Assembly in Singapore, completing major guideline decisions and welcoming new members.
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