The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out how it will modernise regulation to keep pace with advances in science, technology and personalised healthcare while continuing to put patients first. The MHRA will create a modern, adaptive regulatory framework for artificial intelligence as a medical device (AIaMD), establish a Centre for AI and Digital Health and publish an AI Medicines Development Action Plan in 2027. It will also develop an AI-enabled Clinical Trial Protocol Checker to support faster, higher-quality clinical trial applications. To speed up regulatory services, it will introduce a new higher-value service option reducing scientific advice timelines from 90 to 45 days and halve the initial assessment target for qualifying Phase 1 clinical trials to 14 days.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its position on microbiome-based medicinal products (MBMPs), encouraging their development and licensing in the UK. The MHRA considers MBMPs to fall within the existing UK medicines regulatory framework and to be capable, in principle, of meeting UK standards for marketing authorisation where appropriate quality, safety and efficacy are demonstrated. It notes that, depending on the product, MBMPs may be regulated as biological medicinal products and, where the legal criteria are met, as advanced therapy medicinal products (ATMPs).

The MHRA has published a series of guidance documents on clinical investigations for medical devices, setting out key requirements for manufacturers and clinical investigators, including:

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a blog post authored by Proprietary Association of Great Britain (PAGB) CEO, Michelle Riddalls OBE, outlining what PAGB describes as a £1.4bn opportunity to transform healthcare through expanded medicines reclassification. Riddalls argues that increasing switches from prescription-only (POM) to pharmacy (P) or general sales list (GSL) status could improve timely access to treatments for common conditions, strengthen self-care and ease pressure on primary care, with the MHRA describing reclassification as a practical way to broaden access to trusted medicines and enable safe self-management of minor conditions. She states that 74% of adults want more medicines available without a prescription, positioning consumer demand as a key driver of switch applications, and frames reclassification as a catalyst for a prevention-focused healthcare model that enhances the role of community pharmacists and supports wider public health goals. Referencing previous switches to over-the-counter (OTC) status, including Nurofen, Allevia and Calpol, as well as low-dose vaginal oestrogen products and Viagra, she highlights both market impact and social significance and calls for reform of the legal framework for certain injectable medicines, pointing to potential benefits in areas including weight management and emergency treatments. Riddalls states that a 5% reduction in NHS prescribing could save £1.4bn annually, with productivity gains of up to £18bn linked to improved OTC symptom management. PAGB adds that reclassification is one of the most practical and impactful opportunities to strengthen self-care and deliver the ambitions of the NHS 10 Year Plan, citing clear opportunity, strong public demand and persuasive supporting evidence.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to support implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28 April 2026. The guidance package, released on 25 June 2025, includes eight new documents covering trial approval processes, expert advice requirements, labelling standards, safety event reporting, and transitional arrangements. The draft guidance is intended to help trial sponsors prepare for the new regulatory framework while existing rules remain in force until the implementation date.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the consultation on Medical Devices Regulations Routes to market and in vitro diagnostic devices on 14 November 2024. The consultation closed on 5 January 2025. The first part of the government response to the consultation was published on 26 February 2025 and is related to assimilated EU law only. The response to proposals regarding international reliance, UKCA marking and in vitro diagnostic devices will be published separately in due course. The results will inform the regulatory updates, which will introduce additional measures that must be taken before a device can be put on the market.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published and updated several key guidance documents in preparation for amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004, which come into force on 28 April 2026. These developments build on the January 2026 package of MHRA guidance. Central to the update is new draft guidance on good manufacturing practice (GMP) for investigational medicinal products (IMPs), including specific provisions for radiopharmaceuticals, setting out requirements for their manufacture, certification, labelling and use in clinical trials.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance on complying with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R3) good clinical practice (GCP) principles in UK clinical trials. From 28 April 2026, compliance will become a legal requirement under the amended Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031. The updated regulations, introduced through the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, mandate adherence to ICH E6 GCP principles while retaining three UK-specific requirements, including compliance with the Declaration of Helsinki and specific insurance provision requirements. For trials that commenced before 28 April 2026, sponsors must perform documented impact assessments to identify and implement the necessary compliance changes. The guidance invites feedback until 15 April 2026 on how to implement these ICH E6 GCP principles.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published two reports relating to the National Commission into the Regulation of artificial intelligence (AI) in Healthcare: a summary of findings from its call for evidence and a report on the Commission’s wider research and engagement programme. The publications bring together stakeholder views and evidence on the regulation of AI in healthcare. The National Commission will use the findings to develop and refine recommendations for the MHRA, the health system and government, with recommendations due in summer 2026 to help inform the development of a new regulatory framework for AI in healthcare.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on its Phase 1, 14-Day Pilot Programme, which is intended to reduce first-cycle regulatory assessment times for qualifying low-risk phase 1 clinical trials involving healthy adult volunteers. The pilot applies only where applications meet the MHRA’s inclusion criteria and are not excluded, including where trials are first-in-human, involve advanced therapy investigational medicinal products, medical devices or companion diagnostics, or require referral to the Expert Advisory Group or Commission on Human Medicines. The MHRA plans to reduce the assessment timeline in stages during 2026, moving from 28 calendar days from 30 March 2026 to 14 calendar days from 28 December 2026, with capacity increasing to up to four pilot clinical trial applications per week by Q4 2026. Sponsors must self-assess eligibility, book a slot with the MHRA and clearly identify the application as a phase 1 expedited application.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to clarify expectations regarding the application of additional pharmacovigilance (PV) provisions introduced by amendments to Commission Implementing Regulation (EU) No 520/2012 (CIR 520/2012) for UK authorised products. The amendments take effect from 12 February 2026. Although the UK operates an independent medicines regulatory framework, the MHRA notes that the changes will have practical implications for certain UK authorised medicines, particularly Category 2 products and products held by companies with licences in both the UK and the EU. All UK authorised medicines are granted authorisations by the MHRA and must comply with PV requirements set out in Part 11 of the Human Medicines Regulations (HMR) 2012 (SI 2012/1916). However, additional PV requirements apply depending on the category of the product. Category 1 products are subject to the requirements set out in HMR Schedule 12A, while Category 2 products are subject to additional EU PV requirements under CIR 520/2012. The MHRA notes that, while HMR Schedule 12A has historically been aligned with CIR 520/2012, recent amendments mean that UK domestic legislation will no longer be fully aligned with the EU pharmacovigilance framework.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on clinical trials for medicines, outlining roles and responsibilities. This guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, which will come into force on 28 April 2026. The updated guidance clarifies several key areas, including the professions eligible to act as investigators, the required training and experience expectations, the provision of medical support and the delegation of activities. Additionally, Part 2 of Schedule 1 to the amended Clinical Trials Regulations mandates that both investigators and sponsors adhere to all relevant guidance when commencing and conducting a clinical trial.