News Archive

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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EMA Guidelines on Veterinary Medicine - open for consultation

30th January 2026

EMA has published four documents relating to veterinary medicine for public consultation.

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MHRA Newsletter January 2026

30th January 2026

The MHRA’s industry newsletter highlights key regulatory news and updates as the year begins.

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Clinical Trials Highlights - January 2026

29th January 2026

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU

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EMA webinar on the use of platform technologies in the non-clinical and clinical domains

29th January 2026

The EMA are pleased to inform you that a webinar on the use of platform technologies in the non-clinical and clinical domains will be held on 2 March 2026 from 09:25 to 12:15 CET.

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FDA Clinical Decision Support Software – Final Guidance

29th January 2026

The FDA’s Clinical Decision Support Software guidance explains the agency’s regulatory approach for CDS tools used in healthcare.

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