News Archive

EMA Human Medicines Highlights

2nd December 2025

November 2025 Edition out now

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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FDA Issues New Guidance on CGMP for Medical Gases

2nd December 2025

The Food and Drug Administration (FDA) has published a draft guidance to support the implementation of updated manufacturing rules for medical gases.

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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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