The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 8 August 2025 that it will no longer routinely contact UK licence holders about US Food and Drug Administration (FDA) Warning Letters. The agency now requires manufacturing and wholesale licence holders, plus Active Pharmaceutical Ingredient (API) registration holders, to independently monitor and risk assess these warnings. Companies must notify MHRA's Defective Medicines Report Centre if medicines are defective, or the Inspection Action Groups regarding regulatory compliance. The change affects companies using contract manufacturers or API suppliers that receive FDA Warning Letters for UK-marketed medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Artificial Intelligence (AI) Airlock Phase 2 programme report to amend the engagement route into the MHRA referenced in recommendation 20. Recommendation 20, directed at manufacturers of AI as a medical device (AIaMD), now states that qualification cases cannot rely on wording choices or disclaimers alone and advises that manufacturers whose products sit near the qualification boundary engage with the MHRA via info@mhra.gov.uk before deployment rather than after. The MHRA published the AI Airlock Sandbox Phase 2 case study reports on 17 July 2026, bringing together reports prepared by seven participating candidates across three regulatory challenge areas: (1) scope of intended purpose for AIaMD; (2) performance evaluation of AI-powered in vitro diagnostics and (3) post-market surveillance and predetermined change control plans. The reports reflect the independent perspectives of the participating candidates and should not be interpreted as a formal MHRA policy position. While MHRA contributed to shaping the initial hypotheses, refining the regulatory challenges and advising on appropriate testing approaches, all virtual and real-world testing and resulting analyses were carried out entirely by the candidates. The findings and recommendations from these candidate-led reports have been collated and synthesised by MHRA in the overarching programme report.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Good Clinical Practice (GCP) inspections guidance to clarify the submission of inspection dossiers and introduce a dedicated dossier for organisations providing computerised systems to support clinical trials. Organisations being considered for inspection may be required to submit a GCP inspection dossier and clinical trials spreadsheet within 30 days. The MHRA uses this information to assess an organisation’s clinical trial activities and determine whether an inspection is required and, where appropriate, its scope. The guidance provides separate dossier templates, spreadsheets and checklists for standard GCP inspections and inspections of computerised systems. It also includes the MHRA’s position statement and guidance on electronic health records (eHRs), which identifies GCP compliance issues relating to inadequate audit trails, investigator oversight and controls over electronic source data. The MHRA advises that eHR systems should support data integrity, audit trails, investigator verification, appropriate access for inspectors and sponsor representatives, long-term archiving and arrangements to identify potential serious GCP breaches.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for healthcare professionals and patients to highlight the small risk of severe acute pancreatitis associated with glucagon-like peptide-1 receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonists. The MHRA advised clinicians and patients to be alert to symptoms such as severe and persistent abdominal pain, nausea and vomiting, and to seek urgent medical attention if these occur. It noted that acute pancreatitis is a recognised but infrequent adverse effect of these medicines, which are authorised for the treatment of type 2 diabetes and, for some products, weight management and cardiovascular risk reduction. MHRA reaffirmed that GLP-1 medicines are generally safe and effective for their approved uses. It also stressed the importance of reporting suspected adverse reactions through the Yellow Card scheme and confirmed ongoing research through the Yellow Card Biobank to assess whether genetic factors may influence individual risk.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the International Recognition Procedure (IRP), introducing procedural changes from 13 July 2026 to improve efficiency, clarity and predictability. These include a single opportunity to respond to Validation Correction Requests, an eight-week advance notification requirement for new active substance submissions, and a reduction in the Route B reference approval eligibility period from 10 years to 5 years, with transitional arrangements until 31 August 2026. The guidance also introduces a new section on the scope of the IRP, provides clarification on timetable extensions and validation, expands guidance on the application process and pre-submission support, clarifies eligibility for advanced therapy medicinal products, adds guidance on reference medicinal products and comparator products for bioequivalence or therapeutic equivalence testing, and includes a new section with MHRA contact details.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated the MHRA NICE Real World Evidence Scientific Dialogue (RWE SD) programme on 20 May 2026 to support the relaunch of the service and incorporate improvements identified during the pilot phase, helping facilitate the transition to an established service. Key updates include: (1) an updated description of the service offering clarifying the scope, purpose and eligibility, (2) a revised expression of interest process outlining how applicants can apply to the RWE SD programme and what to expect at each stage, (3) enhanced guidance for applicants including clearer expectations around appropriate questions for discussion and (4) a broader content refresh covering language, structure and accessibility to improve clarity, consistency and ease of use for stakeholders engaging with the programme.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its MHRA-NICE Real-World Evidence Scientific Dialogue programme to add approximate application and workshop dates for each cycle. The first cycle will accept applications from May to August, with workshops held in November, while the second will accept applications from November to February, followed by workshops in May. The programme supports discussions between the MHRA, the National Institute for Health and Care Excellence and applicants on real-world evidence relevant to regulatory, health technology assessment and NHS decision-making.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on clinical investigations for medical devices, with revisions published on 6 October 2025. The updates incorporate new flow charts and accompanying guidance (August 2025) clarifying when notification to MHRA is required under the UK Medical Devices Regulations 2002.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance for manufacturers and wholesale dealers following the Windsor Framework agreement. The guidance, initially published on 12 September 2024, now includes Q&As on wholesaler and manufacturer requirements following the agreement of the Windsor Framework and on queries related to the disapplication of Directive 2011/62/EC (the EU Falsified Medicines Directive).

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Health Institution Exemption (HIE) for general medical devices in Great Britain. The exemption allows health institutions, such as NHS Trusts and Boards to design, manufacture or modify devices for in-house use only, subject to safety and quality requirements. Key changes include clearer definitions, practical examples and five principles of good practice: (1) quality management; (2) ensuring device traceability; (3) meeting essential requirements; (4) keeping technical documentation; and (5) post-market monitoring. The exemption applies only to general medical devices and does not cover in vitro diagnostic devices (IVDs). Institutions should inform patients when devices are made under the exemption and report safety issues via the Yellow Card scheme. The update replaces previous in-house manufacturing guidance. Separate EU-aligned rules apply in Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on adverse event reporting requirements for digital mental health technologies, following the implementation of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. The regulations, which came into force on 16 June 2025, strengthen post-market surveillance requirements for medical devices in Great Britain. The guidance provides examples of serious incidents specific to digital mental health technologies, including AI-powered assessments, virtual reality therapy, and therapy chatbots. The requirements aim to facilitate greater traceability of incidents and enable swift regulatory action to protect patient safety. The guidance applies to England, Wales and Scotland, with separate requirements for Northern Ireland under EU regulations.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on clinical investigations for medical devices. MHRA added a flow chart and accompanying guidance on the submission of applications to run medical device clinical trials. The flow chart is designed to help sponsors determine if they need to submit an application to MHRA.