MHRA Guidance & Safety

MHRA NICE Integrated Scientific Advice Service Guidance

The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.

MHRA Field Safety Notices for Medical Devices

The MHRA has published a list of Field Safety Notices (FSNs) for medical devices issued between March 9-13, 2026. These notices are for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.

MHRA Guidance on Medicine Reclassification for Improved Access

The MHRA has published guidance discussing the potential benefits of reclassifying medicines to improve patient access to treatments and reduce pressure on NHS services. The guidance highlights opportunities for self-care and innovation within the consumer healthcare sector.

MHRA Approves Deuruxolitinib (Leqselvi) for Severe Alopecia Areata

The UK's MHRA has approved deuruxolitinib (Leqselvi) for the treatment of severe alopecia areata in adults. This marks a new treatment option for patients and will be kept under close review for safety and effectiveness.

MHRA Advertising Investigations and Decisions

The MHRA has published decisions following investigations into advertising complaints for licensed medicines, specifically concerning weight loss treatments. Ten decisions were made in February 2026 regarding websites and services that highlighted medicinal treatments for weight loss.

UK Agencies Support In-Orbit Pharmaceutical Manufacturing

The UK Space Agency, MHRA, RIO, and CAA have issued a joint statement outlining their support for companies involved in in-orbit pharmaceutical manufacturing. This initiative aims to foster a supportive regulatory environment through guidance and collaborative studies, reinforcing the UK's commitment to space-enabled manufacturing.

Ramipril Recall Due to Packaging Error

The MHRA has issued a precautionary recall for one batch of Ramipril 5 mg Capsules (Batch Number GR164099) due to a packaging error that may have resulted in Amlodipine 5 mg Tablets being included in the cartons. Pharmacy and healthcare professionals are advised to return remaining stock to suppliers.

MHRA Class 2 Recall: Crescent Pharma Ramipril 5mg Capsules

The MHRA has issued a Class 2 medicines recall for one batch of Crescent Pharma Limited's Ramipril 5mg Capsules due to a manufacturing error where incorrect blister strips were found in the packaging. Healthcare professionals are instructed to stop supplying the affected batch immediately and contact patients who received the product.

MHRA Field Safety Notices - February 23-27, 2026

The MHRA has published a list of five Field Safety Notices (FSNs) issued between February 23-27, 2026, for medical devices. These notices are for informational purposes, and recipients are advised to contact the manufacturer with any questions.

MHRA Statement on Pathways Clinical Trial Safety

The MHRA has issued a statement regarding the Pathways clinical trial, emphasizing participant safety. As a precaution, Professor Jacob George has been recused from further involvement due to social media posts made prior to his appointment.