The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a draft Rare Disease Therapies Regulatory Framework. The proposed framework would introduce an Investigational Marketing Authorisation to allow controlled early access to rare disease therapies while further clinical and real-world evidence is generated. The consultation closes 30 July 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals for the indefinite recognition of Conformité Européenne (CE)-marked medical devices in Great Britain (GB), aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies. The consultation closes on 10 April 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies. The guidance aims to streamline pathways for bringing these therapies to patients while maintaining robust safety principles. It covers product design, manufacture, evidence requirements for safety and effectiveness, and post-approval monitoring. The MHRA has developed the guidance with advice from the Highly Personalised Medicines Expert Working Group and may expand it to cover other highly personalised therapies in the future. Stakeholders can comment on the guidance until 31 March 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposed changes to pre-market regulatory requirements for medical devices in Great Britain. The consultation focuses on four key policy areas: UKCA marking, International Reliance, In vitro diagnostic devices, and Assimilated EU law. This follows the recent laying of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations in Parliament. The MHRA aims to inform new legislation, improve patient access to safe and innovative medical products, and strengthen patient safety through these reforms. The consultation will close on 5 January 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA), acting jointly with the Department of Health in Northern Ireland, has launched a consultation on proposed changes to the legal definition of gene therapy medicinal products (GTMPs) in UK legislation. The consultation seeks views on five key proposals: (1) removing the requirement for gene therapies to be biological in origin; (2) clarifying the circumstances in which synthetic or recombinant nucleic acids bring products within scope; (3) ensuring that products involving sequence-specific genome editing are regulated as GTMPs regardless of the type of substance used; (4) maintaining the exclusion of vaccines against infectious diseases from GTMP definitions and (5) updating the Human Medicines Regulations 2012, SI 2012/1916, to reflect the revised definitions. The proposed changes are intended to ensure that the UK regulatory framework keeps pace with advances in gene therapy, synthetic biology and gene editing technologies, while maintaining standards relating to safety, quality and efficacy. The consultation closes on 22 June 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a proposed British Standards Institution (BSI) standard for digital mental health technologies (DMHTs). The MHRA sponsored the development of the draft standard, PAS 709:2026, which provides recommendations for designing and conducting clinical studies to generate evidence for DMHTs that qualify as software as a medical device. According to the MHRA, the standard is intended to apply to the pre-market phase and the collection of real-world data during the early post-market phase. It covers areas including study controls, sample characteristics, safety, effectiveness, engagement endpoints and follow-up periods. The consultation closes on 29 June 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation seeking stakeholder feedback on the operation and impact of medicines and medical devices legislation. The review, mandated under Part 6, Regulation 48 of the Medicines and Medical Devices Act 2021, examines four key regulations: the Human Medicines Regulations 2012, Medical Devices Regulations 2002, Medicines for Human Use (Clinical Trials) Regulations 2004, and Medicines and Medical Devices (Fees) Regulations. The consultation, running until 19 September 2025, aims to assess whether the legislation effectively protects public health without imposing unnecessary regulatory burdens. Findings will inform a report to be published by the Secretary of State for Health and Social Care.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched criminal investigations following 41 confirmed botulism cases linked to unlicensed botulinum toxin products between 4 June 2025–6 August 2025. The MHRA criminal enforcement unit warns that individuals involved in the sale or supplying of unlicensed Botox products could face up to two years imprisonment and limitless fines under the Human Medicines Regulations 2012 (SI 2012/1916). This enforcement action specifically targets the illegal supply of these products through informal settings and social media channels.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new digital hub in Leeds to advance healthcare technology and support regional growth. The MHRA selected Leeds because of its strong digital health expertise, robust academic base, and thriving technology community. The hub will be located at Wellington Place in Leeds city centre and aims to enhance regulatory agility and strengthen collaboration with NHS organisations, academic institutions, and digital health networks. The MHRA plans to create approximately 30 highly skilled roles in digital delivery, software development, and data science, with further expansion planned. These roles will be part of the Digital and Technology Group (DTG), which is responsible for optimising infrastructure and ensuring the secure use of data to deliver world-class services, while keeping regulatory processes in step with technological advancements and contributing to improved patient care and public health outcomes.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance to help manufacturers navigate UK medical device regulations for digital mental health technologies (DMHTs). The guidance, an output from a three-year Wellcome-funded project launched in 2023, explains how to define the intended purpose of DMHTs, when they are considered medical devices, and how risk classification is determined. MHRA has developed this guidance with input from NICE, NHS experts, researchers, healthcare professionals, and people with lived experience to address the growing mental health crisis in the UK. The guidance aims to ensure DMHTs are effective, reliable, and acceptably safe, while providing greater confidence to users of mental health apps and supporting safe access to these tools.

The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with NHS England (London) and the London Health Innovation Networks (HINs), has announced the launch of a new regulatory sandbox, designated London Region I. The programme will enable artificial intelligence (AI)-enabled medical devices to be deployed in live clinical settings under MHRA oversight, generating real-world evidence on their safety and effectiveness. Up to 10 AI medical device manufacturers will be selected to participate in the initial phase. The programme will support collaboration between providers and innovators by helping to match technologies with real system needs, enabling rapid, evidence-led deployment in practice and helping to ensure patients can access new technologies earlier while maintaining high standards of safety. MHRA will invite expressions of interest from interested NHS providers and AI medical device manufacturers in July 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the most significant update to the UK’s clinical trials regulatory framework in over two decades, aligning with International Clinical Trials Day. The reforms aim to create a more efficient, inclusive, and adaptable environment for clinical research in the UK, placing participants at the centre of the process and expediting the approval and delivery of innovative treatments to patients and the NHS. These changes are part of a broader strategy to secure the UK’s global leadership in life sciences and clinical research.