News Archive

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.

Read More+

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.

Read More+

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.

Read More+

EMA Guidelines on Veterinary Medicine - open for consultation

30th January 2026

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

Read More+

MHRA Newsletter January 2026

30th January 2026

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

Read More+

Clinical Trials Highlights - January 2026

29th January 2026

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

Read More+

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.

Read More+

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.

Read More+

Veterinary Medicines Highlights - January 2026

29th January 2026

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

Read More+

MHRA takes over chair of the International Access Consortium for 2026

27th January 2026

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun its 2026 term as Chair of the Access Consortium, strengthening global regulatory collaboration to improve patient access to new medicines.

Read More+