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News Archive
ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process
26th March 2025Announced 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.
MHRA - MHRA launches new monthly safety bulletin
26th March 2025Sign up today
MHRA - Safety communications concerning medicines, medical devices and other healthcare products
26th March 2025New Guidance
MHRA Blog - Exploring AI in Healthcare: Insights from the AI Airlock Pilot
26th March 2025Blog post by Jincy Robin, 26th March 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
26th March 202510-13 March 2025
WHO - Announces new collaborating centre on AI for health governance
26th March 2025The 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.
EMA - Small and Medium-sized Enterprises (SMEs) Highlights
25th March 2025March 2025
EMA - Human Medicines Highlights
20th March 2025The newsletter for patients, consumers and healthcare professionals, March 2025 Edition
EMA - ICH M11 Guideline
20th March 2025ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
MHRA - Decentralised manufacture hub - New Regulation
20th March 2025Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.
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