MHRA Guidance & Safety

RSV Vaccine Factsheet – Information for Patients, Parents and Carers

The MHRA published a new patient factsheet on RSV vaccination on 15 April 2026. The factsheet provides comprehensive information about respiratory syncytial virus (RSV), including eligibility criteria, safety and effectiveness of vaccines used in the UK, side effects, pregnancy considerations, and contraindications. The document is designed to help patients, parents, and carers understand RSV vaccines and make informed decisions about vaccination.

Field Safety Notices: 6 to 10 April 2026

MHRA published a weekly compilation of 15 Field Safety Notices (FSNs) for medical devices issued 6-10 April 2026. FSNs cover devices including gastric balloons, surgical systems, intraocular lenses, CT systems, and diagnostic equipment. MHRA notes it publishes FSNs for information only, and recipients must act on FSNs received directly from manufacturers.

Olezarsen (Tryngolza) Approved for Familial Chylomicronemia Syndrome

The MHRA has approved olezarsen (Tryngolza) for the treatment of familial chylomicronemia syndrome (FCS) in adults. The approval was granted on 10 April 2026 to Swedish Orphan Biovitrum AB (publ) via IRP Route B. In a study of 66 adults, patients treated with Tryngolza showed an average 32% reduction in triglycerides after 6 months, compared with a 12% average increase in the placebo group, with benefits maintained and further improved after one year.

MHRA-NICE Aligned Pathway Accelerates Patient Access to Medicines by 3-6 Months

The MHRA and NICE launched an aligned pathway that synchronizes regulatory approval with health technology assessment, enabling new medicines to reach NHS patients 3-6 months earlier than previous timelines. This integration brings together the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence to deliver simultaneous regulatory and reimbursement decisions.

UK and US deepen regulatory cooperation on medical devices

MHRA and FDA announced strengthened cooperation on medical device regulation to support faster access to safe, innovative technologies for patients in both countries. The regulators will explore mutual recognition mechanisms, reduce duplication for manufacturers, and streamline approval processes while maintaining independent safety standards. The UK MedTech sector employs over 195,000 people.

Environmental Risk Assessments for Medicines

MHRA published guidance on environmental risk assessments (ERAs) for medicinal products in the UK. The guidance clarifies that all marketing authorisations require evaluation of potential environmental risks under Schedule 8 of the Human Medicines Regulations. Marketing authorisation holders must assess physicochemical and ecotoxicological properties and environmental fate of active substances, proposing mitigation measures where risks cannot be excluded.

Sevabertinib (Hyrnuo) approved for advanced HER2-positive lung cancer

MHRA granted marketing authorisation to Bayer PLC for sevabertinib (Hyrnuo), a protein kinase inhibitor for adults with advanced HER2-mutated non-small cell lung cancer that has spread or is unresectable. The drug was approved via Project Orbis, a global regulatory partnership. Clinical trials showed a 71% positive response rate in previously treated patients.

Monthly Drug and Medical Device Safety Roundup

MHRA published its monthly safety roundup for March 2026, consolidating alerts on medicines and medical devices. The roundup includes multiple drug and device batch recalls affecting various therapeutic areas. Healthcare providers and patients should review the specific alerts to identify affected products in their supply chain or treatment.

Clinical Investigations in Northern Ireland for Medical Devices

MHRA published guidance clarifying clinical investigation requirements for medical devices in Northern Ireland under the EU Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746. Manufacturers must notify MHRA when using non-UKCA or non-CE marked devices on human participants. The guidance establishes that a single EU MDR application covers sites in both Northern Ireland and Great Britain.

Clinical investigations for medical devices

MHRA published guidance explaining requirements for clinical investigations of medical devices in Great Britain under the UK MDR 2002. Manufacturers must notify MHRA of planned investigations involving non-UKCA or non-CE marked devices on human participants unless an exemption applies. The guidance clarifies different regulatory pathways for Great Britain versus Northern Ireland.