News Archive

MHRA - Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation

19th June 2025

New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.

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MHRA - Electronic Common Technical Document (eCTD) submissions update

18th June 2025

Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.

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MHRA - First major overhaul of medical device regulation comes into force across Great Britain

16th June 2025

New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.

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MHRA - Human Medicines Highlights June 2025

16th June 2025

The newsletter for patients, consumers and healthcare professionals

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MHRA - Unprecedented boost for clinical trials under 10 Year Health Plan

16th June 2025

Millions will take part in clinical trials under the 10 Year Health Plan which will speed up clinical research.

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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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