News Archive

EMA - interim report on the scientific advice pilot for high-risk medical devices.

26th March 2025

Added 24th March 2025

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FDA - FDA Roundup 21st March 2025

26th March 2025

An at-a-glance summary of news from around the agency:

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ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process

26th March 2025

Announced 20th March 2025 The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025. The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.9. The eCTDv4.0 Q&A v1.9 is available for download on the ICH ESTRI page for eCTD v4.0 here.

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MHRA - MHRA launches new monthly safety bulletin

26th March 2025

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MHRA - Safety communications concerning medicines, medical devices and other healthcare products

26th March 2025

New Guidance

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MHRA Blog - Exploring AI in Healthcare: Insights from the AI Airlock Pilot

26th March 2025

Blog post by Jincy Robin, 26th March 2025

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

26th March 2025

10-13 March 2025

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WHO - Announces new collaborating centre on AI for health governance

26th March 2025

The World Health Organisation (WHO) designated the Digital Ethics Centre at Delft University of Technology in the Netherlands as a WHO Collaborating Centre on artificial intelligence (AI) for health governance.

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EMA - Small and Medium-sized Enterprises (SMEs) Highlights

25th March 2025

March 2025

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EMA - Human Medicines Highlights

20th March 2025

The newsletter for patients, consumers and healthcare professionals, March 2025 Edition

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