From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has selected the most important regulatory updates from the past month.
MHRA sets expectations for environmental risk assessments of medicines
1 April 2026
The MHRA has published guidance outlining requirements for environmental risk assessments for medicinal products in the UK. The document clarifies how companies should evaluate and manage potential environmental impacts, supporting more sustainable medicines development and regulatory compliance. Read more
MHRA–NICE pathway aims to speed access to NHS medicines
1 April 2026
The MHRA and the National Institute for Health and Care Excellence (NICE) are streamlining decision-making through an aligned pathway designed to bring new medicines to NHS patients 3–6 months earlier. The approach aims to improve coordination between regulatory approval and health technology assessment, helping patients access treatments more quickly while giving developers greater certainty. Read more
MHRA clarifies roles and responsibilities in clinical trials
13 April 2026
The MHRA has issued guidance outlining key roles and responsibilities in clinical trials, including who can act as an investigator and the required training and experience. The document also covers provision of medical oversight and delegation of tasks, helping ensure trials are conducted safely and in line with regulatory expectations. Read more
UK launches major clinical trial reforms to speed study approvals
27 April 2026
The MHRA and the Health Research Authority have introduced a wide-ranging package of clinical trial reforms, the most significant in over 20 years. The changes include faster assessment of first-in-human studies, a new notifiable trial route for lower-risk studies, and quicker approval of modifications, aiming to accelerate trial start-up while maintaining high safety standards. Read more
How do these changes affect you?
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