The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on the International Council for Harmonisation (ICH) M15 guideline for Model Informed Drug Development (MIDD). The guideline, which has reached Step 2b in the ICH process, aims to establish a harmonised assessment framework for MIDD evidence, including recommendations for planning, model evaluation, and documentation. The MHRA participated in the drafting process and is now seeking input from stakeholders until 31 March 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the International Council for Harmonisation (ICH) M13B guideline concerning bioequivalence assessment for immediate-release solid oral dosage forms. The draft guideline, developed by the ICH Expert Working Group, outlines scientific and technical requirements for study design and data analysis in bioequivalence assessment. This represents the second guideline in the series since MHRA became a full ICH member in May 2022. The consultation closes at 11:59pm on 31 July 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the International Council for Harmonisation (ICH) E21 guideline regarding the inclusion of pregnant and breast-feeding individuals in clinical trials. The draft guideline establishes principles for including these groups in clinical trials and drug development plans, covering scientific, regulatory and ethical considerations. The guideline aims to address the current lack of data on medicine use during pregnancy and breast-feeding by enabling appropriate inclusion in trials where medically suitable. Stakeholders can submit responses on 5 September 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation seeking UK stakeholder feedback on the revised International Council for Harmonisation (ICH) guideline M4Q(R2). The guideline covers quality information requirements for registration and lifecycle management of human pharmaceuticals. The consultation closes on 26 October 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the opening of applications for the second round of its AI Airlock regulatory sandbox programme, supported by £1m in new funding. The programme, which creates a supervised testing environment for artificial intelligence medical devices, implements commitments from the government's AI Opportunities Action Plan and response to the Regulatory Horizons Council report. Applications open 23 June 2025 and close 14 July 2025. The initiative is backed by the new Regulatory Innovation Office (RIO) to support more flexible regulatory approaches for emerging technologies.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Airlock Sandbox Phase 2 Programme Report, setting out findings from the second phase of its regulatory sandbox, which ran from April 2025 to March 2026 and examined seven AI medical device case studies across three key regulatory challenge areas: intended purpose and validation, AI-powered in vitro diagnostic (IVD) devices, and lifecycle management through post-market surveillance (PMS) and predetermined change control plans (PCCPs). The report primarily summarises the regulatory challenges identified through the programme and presents key insights into how existing medical device regulation applies to emerging AI technologies, particularly where products evolve over time, rely on complex data environments or incorporate generative AI.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Deputy Director for Artificial Intelligence (AI) and Software, Jessica Paulsen, will outline its developing approach to software and AI-enabled medical devices at AdvaMed 2026. The approach includes more flexible regulation throughout a device’s lifecycle, regulatory sandboxes and closer international collaboration, with the aim of supporting faster access to new technologies while maintaining patient safety. Building on its 2030 Strategy, the MHRA plans to develop an adaptive framework for AI as a medical device, establish a Centre for AI and Digital Health, improve device data and traceability, and expand reliance and recognition routes with trusted international regulators. Its AI Airlock regulatory sandbox and regional healthcare partnerships are testing innovative technologies in healthcare settings and generating evidence to inform future regulatory approaches for devices that evolve throughout their lifecycle.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a blog outlining the implementation of the new Decentralised Manufacturing (DM) legislation, which came into force on 23 July 2025 under the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 2025/87.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have jointly introduced the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which will take effect on 28 April 2026. Developed with the devolved governments and extensive stakeholder input, these reforms constitute the most substantial update to UK clinical trials legislation in two decades. The new regulations aim to strengthen participant protection and patient safety while streamlining approvals and reducing unnecessary burdens on researchers. They incorporate the latest international Good Clinical Practice (ICH-GCP E6(R3)) guidelines, ensuring all trials adhere to high ethical and scientific standards. The updated framework is intended to make clinical trials quicker and easier to establish and manage, maintaining robust oversight while encouraging innovation, transparency, and inclusivity across the UK research landscape.

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out plans for a new five-year strategy designed to strengthen its position as a global leader in health regulation. The agency highlights that personalised medicine, AI-based diagnostics and global supply chain challenges require a regulator that is adaptable and responsive. Its approach seeks to empower patients by introducing a clearer, risk-proportionate regulatory framework. This aims to ensure more agile regulation, maintain public trust and better reflect patient needs across the UK.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is proposing to prepare secondary legislation to implement proposals to increase fees, which would be in force from April 2025. The MHRA held a public consultation on proposed amendments to its statutory fees between 29 August 2024 and 24 October 2024. In its response the government noted the majority of respondents did not agree with the proposal for a new medical devices registration fee. The government has, therefore, decided to proceed with the wider fees uplift and continue exploring options on this medical device registration fee.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its final Business Plan for the 2025–2026 period, in the context of 2023–2026 MHRA Corporate Plan. The plan for the year ending 31 March 2026 aims to modernise the regulation of medicines by reshaping processes and frameworks to better meet evolving objectives. To do so, it advocates using defined criteria to prioritise regulator involvement where it adds value, such as by promoting sustainable practices, including green chemistry and reducing plastic usage, for generic medicines. Furthermore, the plan calls for lifecycle risk-based approaches that permit more efficient, self-declared processing methods when safety and efficacy standards are satisfied, with responsibilities clearly allocated. Finally, the framework is revised to be outcome-based, supporting broader regulatory reforms such as the new clinical trials framework and provisions for point-of-care manufacture.