News Archive

EMA - Overview of comments received on ICH M11 Technical Specification Updated Step 2b

12th June 2025

Comments Published

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Pharmacovigilance News - March 2025 to May 2025

12th June 2025

The RQA GPvP Committee have collated relevant pharmacovigilance news and will share quarterly.

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MHRA - Decentralised Manufacture Guidance Documents

11th June 2025

Updated and published guidance on decentralised manufacture released.

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MHRA - Human medicines Modular Manufacture and Point of Care regulations 2025: Overview

11th June 2025

Information to help you understand and prepare for the main regulatory changes that The Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 will introduce for the manufacture of medicines at - or close to - the point of patient care.

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MHRA - Documentation for implementation of data requirements under the new Post-Market Surveillance regulations

10th June 2025

Documentation changed to support changes to Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs)

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MHRA - MHRA launches new digital hub in Leeds to drive innovation and regional growth

6th June 2025

A new digital hub in Leeds is being launched by the Medicines and Healthcare products Regulatory Agency (MHRA), marking a significant step in the agency’s long-term commitment to advancing innovation and strengthening its presence across the UK.

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