The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have jointly delivered the Integrated Scientific Advice (ISA) service, which provides pharmaceutical companies with coordinated regulatory and health technology assessment (HTA) advice through a single application process, meeting and integrated report. Intended primarily for medicines in clinical development aligned to MHRA and NICE pathway timelines, the service replaces the previous joint advice model and aims to support earlier patient access by clarifying evidence requirements for market authorisation and HTA at an early stage, including advice on pivotal study design, real-world evidence generation and strategic planning, although it does not cover medical devices. Applicants must confirm eligibility, submit a request form, agree a contract and fee, and provide a briefing book and presentation before attending an advice meeting, after which a single report is issued within 80 working days of acceptance, subject to complete and timely submissions; limited factual clarifications may be requested. A single fee, payable in two instalments, covers the service, with a waiver available for the MHRA component for eligible UK-based SMEs, and the advice provided is not legally binding and reflects the information and regulatory context at the time.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance to phase out animal testing in medicines development by increasing the use of new approach methodologies (NAMs). The guidance lays out regulatory principles that specify: (1) generic or biosimilar products, as well as drugs that are not pharmacologically active in animals, should not be tested on animals and (2) in contrast, products with novel pharmacological actions should continue to undergo animal testing in line with international guidelines. Furthermore, by the end of 2026, the MHRA will offer an early review of Module 4 of Marketing Authorisation applications for products developed without animal testing. This process will provide non-binding written opinions on the adequacy of the data submitted. Companies taking advantage of this early review scheme will incur a fee designed to recover administrative costs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance, developed with NHS England (NHSE), clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain. The guidance aims to give developers, suppliers and NHS organisations greater regulatory clarity to support the safe adoption of AVT tools, including AI scribes used to record and summarise conversations between clinicians and patients. AVT products used solely for transcription, summarising clinical conversations, drafting letters or suggesting clinical codes for clinician review are not regulated as medical devices under the current framework. However, products intended to support diagnosis, treatment or prevention, or that take automated action without clinician review, remain subject to medical device regulation. The guidance does not change the law but explains how existing medical device regulations apply to AVT products. It also confirms that clinicians remain responsible for reviewing and verifying AI-generated outputs before use in patient care, while NHS boards and executive teams should ensure AVT deployment is supported by appropriate clinical oversight, governance, staff training and procurement processes.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on applying for regulatory advice meetings regarding medical devices and in vitro diagnostic devices. The guidance establishes a fee of £987 per meeting, with payment required at least three weeks before the scheduled meeting date. The MHRA will propose meeting dates within 15 days of receiving requests. Each meeting is limited to one hour and requires applicants to deliver a 10-15 minute presentation. Following the meeting, attendees must submit meeting notes within 15 working days, which the MHRA will review for accuracy and return within 30 days.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the UK’s first official guidance on the regulatory framework for the development of bacteriophage therapies—treatments that use viruses to target and destroy harmful bacteria. The guidance covers two main types of phage therapies: (1) combined phage products designed for common infections and circulating strains, and (2) personalised phage therapies tailored for individual patients with rare or highly resistant infections. The document provides regulatory guidance for both licensed and unlicensed medicines, covering preclinical development through to post-licensure pharmacovigilance activities. It is intended to assist researchers and companies in developing phage-based medicines that comply with UK safety, quality and efficacy standards. The guidance also clarifies how existing UK and international regulatory frameworks apply to phage treatments and provides practical advice across all development stages.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the outcome of its call for evidence on health institution exemptions within the medical devices regulatory framework. The survey, which ran from 1 August to 15 September 2025, gathered insights from health institutions across Great Britain on their experience of the exemption, sometimes referred to as in-house manufacturing exemption. The MHRA aims to refine the policy to enable exempted devices to be used beyond health institutions, strengthen safety measures through enhanced post-market surveillance, and support delivery of care closer to communities. The outcome will inform subsequent consultations, guidance updates, and regulatory changes planned for the coming year as part of the Medical Devices Regulatory Reform roadmap.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to AI, which adopts the government’s recommendations set out in the white paper ‘A pro-innovation approach to AI regulation’ based on principles such as safety, security, fairness, accountability etc. The MHRA considers the opportunities and risks of AI as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that makes evidence-based decisions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Early Access to Medicines Scheme (EAMS) by introducing a new Scientific Opinion application form. This follows the new guidance about how to submit new applications to the EAMS, which was published by the MHRA in September 2024.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that a new fee is planned to come into effect on 1 April 2026 and will apply for the financial year 2026-27. It will replace the current one-off registration fee regime. Manufacturers will be charged annually based on how many Level 2 Global Medical Devices Nomenclature (GMDN)® Categories their devices are registered under. If multiple GMDN® and products are registered under the one Level 2 Category, then they will be charged once per year for that Level 2 GMDN® Category. Some products fall under more than one Level 2 GMDN® Category, and these will also only be charged once per a year. The estimated unit cost for the fee from 1 April 2026 will be in the region of £300 per year, per Level 2 GMDN® Category. Manufacturers need to create an account on the MHRA Device Online Registration System (DORS) before proceeding to register a device.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper outlining proposals for a new regulatory framework to support the development and approval of rare disease therapies. Developed in collaboration with the newly formed Rare Disease Consortium, the framework is expected to be finalised in 2026, following a public consultation planned for early 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the National Commission into the Regulation of AI in Healthcare’s recommendations for a proportionate, lifecycle-based and system-wide framework for regulating artificial intelligence (AI) in healthcare. The Commission recommends updating the UK Medical Devices Regulations 2002, SI 2002/618 to clarify when software and AI-enabled products qualify as medical devices and how they should be classified.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a report by the Commission on Human Medicines (CHM) which outlines recommendations for the safe and effective use of adrenaline auto-injectors (AAIs), including their potential placement in public places, such as restaurants and entertainment venues, to provide for quicker and safer access and treatment for allergic reactions. The recommendations come from ‘the most thorough and rigorous scientific review of the products to date by the MHRA and the CHM’s Adrenaline Auto-injector Expert Working Group’. A public consultation will also be required, however, before AAIs are made more widely available in public places.