28 August 2025
From the newsfeeds of the Medicines and Healthcare products Regulation Agency, Arex Advisor has rounded up a selection of highlights from July to August 2025.
Medicines marketing authorisation: change of ownership application
14 August 2025
An updated version of the attachment for change of ownership application has been published. Read more
Cancel a marketing authorisation: updated form
14 August 2025
An updated version of the form for cancelation of a marketing authorisation, traditional herbal registration or parallel import product licence or withdrawal of a pending submission has been published. Read more
UK stakeholders consultation on revised international guideline, ICH M4Q(R2)
12 August 2025
The MHRA has opened a consultation with UK stakeholders to seek input on a revised international guideline. The guideline aims to standardise how quality information is collected for both the registration and ongoing lifecycle management of human medicines. Read more
MHRA streamlines regulatory pathways to boost innovation and patient access
6 August 2025
In July, the UK government published the 10 Year Health Plan for England and the Life Sciences Sector Plan, both highlighting the MHRA’s central role in enabling innovation and patient access to medical technologies. The MHRA is advancing new reliance pathways with regulators in the US, Canada, and Australia, while also consulting on the indefinite recognition of CE-marked products to safeguard supply. These measures, along with new post-market surveillance rules and upcoming pre-market legislation, aim to streamline regulation, reduce costs for manufacturers, and accelerate patient access. The Agency is also developing early access routes for innovative devices and expanding the AI Airlock pilot to support safe adoption of AI in healthcare. Together, these initiatives underline the MHRA’s focus on balancing patient safety with faster access to innovation and sector growth. Read more
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