Medicines and Healthcare products Regulatory Agency
gov.uk
Imported from official source
UK medicines and medical devices regulator; recalls and safety alerts.
Publications 67
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Electronic Application Forms (eAF) for UK medicines licensing applications
Current eAF forms are available for applicants to download and use. Existing submission routes, validation requirements and assessment processes remain unchanged.
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Decision: Advertising investigations: September 2026
Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
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MHRA joins global regulators in call to advance alternatives to animal testing
International statement co-developed by UK medicines regulator
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Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information...
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DIA and MHRA announce speaker line-up for inaugural global summit
International leaders will gather to address some of the most significant opportunities and challenges facing healthcare today at the DIA-MHRA Global Summit.
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Field Safety Notices: 21 to 25 September 2026
List of Field Safety Notices from 21 to 25 September 2026.
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MHRA Safety Roundup: September 2026
Summary of the latest safety advice for medicines and medical device users
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Professor Dame Anna Dominiczak, Professor Alison Strath, and Fiona Cohrane: Catalysing the medicines ecosystem in Scotland
Scotland’s growing commercial research infrastructure and strong NHS, academic and industry partnerships are helping widen access to clinical trials, accelerate adoption and strengthen the UK life ...
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Five new commissioners appointed to the Commission on Human Medicines (CHM)
The CHM provides independent expert advice to ministers on the safety, quality and efficacy of medicines.
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MHRA welcomes sentencing after fraud convictions over falsely certified medical devices
Following convictions related to falsely certified medical devices, the MHRA has welcomed the sentencing in a long-running enforcement investigation.
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MHRA approves lurbinectedin for adults with extensive-stage small cell lung cancer
As with all licensed medicines, the MHRA will keep the safety and effectiveness of lurbinectedin under close review.
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Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution f...
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Field Safety Notices: 14 to 18 September 2026
List of Field Safety Notices from 14 to 18 September 2026.
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Beyond ADMET: AI for medicines safety - survey
The MHRA and the Regulatory Innovation Office (RIO) invite organisations to share their views on the use of artificial intelligence (AI) in medicines development.
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Funding opportunity launched to strengthen UK regulatory science and support healthcare innovation
Four new centres of excellence will bring together expertise across academia, industry, healthcare and regulation to keep pace with advances in healthcare and life sciences
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Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts h...
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Class 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38
Martindale Pharmaceuticals has informed the MHRA of an error with the linear barcode of some batches of Clobazam 5mg/5mL and 10mg/5mL Oral Suspension 150mL.
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MHRA sets out steps to prevent avoidable harm from patient hoists
A National Patient Safety Alert has been issued setting out practical steps to reduce the risk of harm when using patient hoists through improved checks and maintenance.
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Guidance: National Patient Safety Alert Supporting Information. Patient hoists and slings: incidents and case examples.
Supporting information to accompany the National Patient Safety Alert on patient hoists and slings NatPSA/2026/005/MHRA.
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National Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)
Fatal and serious harm continues to occur when patients fall from hoists or slings during transfers and repositioning. A review of recent incidents with a fatal outcome and wider surveillance data ...
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Beyond ADMET: AI for medicines safety stakeholder survey
The MHRA and the Regulatory Innovation Office (RIO) invite organisations to share their views on the use of artificial intelligence (AI) in medicines development.
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MHRA and Malaysia strengthen partnership on healthcare innovation and research
The MHRA has reaffirmed its commitment to strengthening regulatory collaboration with Malaysia following high-level discussions in Kuala Lumpur.
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Field Safety Notices: 7 September to 11 September 2026
List of Field Safety Notices from 7 September to 11 September 2026.
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Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare
New recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain hi...
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Research: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework
Recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework for AI in healthcare.
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Field Safety Notices: 31 August to 4 September 2026
List of Field Safety Notices from 31 August to 4 September 2026.
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Decision: Advertising investigations: August 2026
Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
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Field Safety Notices: 24 to 28 August 2026
List of Field Safety Notices from 24 to 28 August 2026.
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MHRA and Manchester NHS partner on health innovation sandbox
New partnership to create health innovation sandbox that will test promising new technologies and build evidence to accelerate the safe adoption of technologies, including AI, in the NHS.
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Filters should be used during the administration of Parenteral Nutrition for patients in all care settings
Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
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Filters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
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MHRA consultation on statutory fees (2026)
Proposals for ongoing cost-recovery and to fund higher value services.
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Guidance: 14-day assessment stepwise implementation programme for Phase 1 clinical trials
The stepwise implementation programme aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
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Transparency data: Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2026-27
HRA transactions over £500 made using the government procurement card (GPC).
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Decision: Marketing authorisations Granted in 2026
Marketing authorisations granted in 2026.
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Guidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
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National assessment procedure for medicines
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
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Transparency data: MHRA Performance Data
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
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Corporate report: MHRA-NICE Real-World Evidence Scientific Dialogue
A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
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Pre-submission Advice & Support for Innovative Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
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Guidance: International Recognition Procedure
How to use the procedure for medicines licensing applications.
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Decision: Human medicines: register of electronic export certificates
Department of Health and Social Care and MHRA register of electronic export certificates (human).
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Guidance: COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
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COVID-19 test approval: how to apply
How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.
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Decision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
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Renewing marketing authorisations for medicines
How to renew marketing authorisations for products granted through different routes and at different times.
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Guidance: Guidance on pharmacovigilance procedures
This guidance summarises our approach to pharmacovigilance
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Access, new active substance and biosimilar work sharing initiatives
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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Decision: Medical devices given exceptional use authorisations
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
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