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News Archive
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2nd December 2025The Food and Drug Administration (FDA) has published a draft guidance to support the implementation of updated manufacturing rules for medical gases.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.
International Council for Harmonisation (ICH) Assembly Welcomes New Members and Observers
2nd December 2025ICH expands its global regulatory network by admitting new members and observers during its November 2025 meeting.
Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025
2nd December 2025The 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.
New MHRA-supported research reveals patterns of vaccine-derived poliovirus spread
2nd December 2025A major study offers new insight into how vaccine-derived poliovirus type 2 spreads and what this means for global eradication.
Innovative approaches to Med Tech regulatory reform
28th November 2025The MHRA sets out new steps to modernise the UK’s medical technology regulatory framework.
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