MHRA

The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).

WHO recognition affirms MHRA’s commitment to regulatory excellence, innovation and global collaboration

Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles).

The microscopic bacteria living in women’s bodies could be a powerful tool for personalised, non-invasive treatment and earlier diagnosis.

Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with the MHRA and NICE to allow parallel decision making over licencing and value.

Updates on regulatory reform and plans to support innovation.

List of Field Safety Notices from 28 July to 1 August 2025.

A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.

New jobs to strengthen innovation, safety and smarter regulation across the UK health and life sciences sector. 

Due to risk of infection, non-sterile alcohol-free wipes are not appropriate for the treatment of injuries, wounds or on broken skin, nor for cleaning of intravenous lines.

LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.

Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.