News Archive

Mock example developed to illustrate quality modules of ICH M4Q (R2) Common Technical Document

18th February 2026

The International Council for Harmonisation (ICH) has published a mock example to help stakeholders understand the revised quality modules in the updated CTD guideline.

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Timelines for acceptance of CE-marked medical devices in Great Britain (GB)

18th February 2026

MHRA has published expected timelines for when CE-marked medical devices and IVDs can continue to be accepted in Great Britain.

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Updates to Clinical Trials Regulations — Transitional Arrangements Guidance

18th February 2026

The MHRA has updated its clinical trials transitional guidance to clarify timelines and labelling requirements under the new UK clinical trial regime.

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Chemical Safety and Biosafety Progress Report

11th February 2026

February 2026 (OECD)

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Impact of the amended CIR 520/2012 to UK-authorised products Blog

11th February 2026

The MHRA Inspectorate explains how recent changes to the EU’s pharmacovigilance implementing regulation (CIR 520/2012) affect UK-authorised medicines and how companies should respond.

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FDA guidance on Computer Software Assurance for production and quality management system software

10th February 2026

The FDA has published final guidance explaining how manufacturers can use a risk-based approach to assure software used in production and quality systems.

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Updates to CIR 520/2012 – information for UK Marketing Authorisation Holders

10th February 2026

The MHRA has published guidance clarifying how amendments to Commission Implementing Regulation (CIR) 520/2012 affect UK-authorised medicines from 12 February 2026.

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Mila to Millions: A New Era of Individualized Medicines

3rd February 2026

MHRA publishes a powerful guest blog by Julia Vitarello on why the UK must lead the way in personalised medicines that treat people with rare genetic diseases.

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