5 March 2026
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from the past month.
MHRA clarifies pharmacovigilance expectations under updated CIR 520/2012
9 February 2026
The MHRA has issued updated guidance for UK Marketing Authorisation Holders on the application of revised pharmacovigilance provisions set out in CIR 520/2012. The clarification outlines regulatory expectations for UK-authorised products, helping companies ensure compliance with the strengthened safety monitoring requirements overseen by the Medicines and Healthcare products Regulatory Agency. Read more
MHRA consults on indefinite recognition of CE-marked devices in GB
16 February 2026
The MHRA has launched a consultation on proposals to allow indefinite recognition of CE-marked medical devices in Great Britain. The move aims to protect patient access and maintain supply continuity while ensuring that safe and effective medical technologies remain available on the GB market. Read more
MHRA and NICE offer integrated scientific advice for medicines
20 February 2026
The MHRA and the NICE provide an Integrated Scientific Advice service to support medicines development. The joint offering enables companies to receive coordinated regulatory and health technology assessment input in a single process, helping align evidence generation plans and streamline routes to patient access in the UK. Read more
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