News Archive

EMA - ICH M11 Guideline

20th March 2025

ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline

MHRA - Decentralised manufacture hub - New Regulation

20th March 2025

Information 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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EMA - Centralised Procedures Q&A Document Updated

11th March 2025

Updated Feb 2025

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EMA - Extension to GDP Regulatory Expectations and Certificates Ends

11th March 2025

The GMP / GDP Inspectors Working Group extended the validity of GDP certificates as a temporary regulatory flexibility in 2021. The working group prolonged this extension until the end of 2024. From 2025, this extension no longer applies.

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EMA - Veterinary Medicines Highlights March 2025

10th March 2025

The 20th edition of the Veterinary Medicines newsletter.

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MHRA - Government response to statutory fees

10th March 2025

MHRA consultation on statutory fees: proposals on ongoing cost recovery The MHRA held a public consultation on proposed amendments to its statutory fees. The consultation ran between 29 August 2024 and 24 October 2024 and was held jointly with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021. This document summarises the responses to the consultation and outlines our response to feedback and proposed next steps.

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MHRA - New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections

10th March 2025

In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial infections faster and more accurately.

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