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A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.Continue Reading Virtual and Digital Health Digest – October 2025

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2025 from the the United Kingdom, and European Union.

The UK government has published a number of initiatives and responses to consultations this month that have included important proposals for devices and digital health. The 10 Year Health Plan and Life Sciences Sector Plan both refer to integration of digital health into the National Health Service. Further, the Medicines and Healthcare products Regulatory Agency’s statement on the future regulation of devices makes some key changes relevant to software, including that the proposed international reliance pathways will include software. There has also been some useful guidance on synthetic data, and on reporting adverse events for software devices. These initiatives continue to demonstrate that digital technologies are seen as a growth area and are important for delivering the government’s long-term healthcare plans. Continue Reading Virtual and Digital Health Digest – August 2025

On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union’s AI Act. This is an important development for companies, including in the Life Sciences sector, building their own GPAI models, as well as using, integrating and/or further developing third-party GPAI as…

On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.

For pharmaceutical, MedTech, and biotech companies, the Strategy may, at least in theory, represent a positive shift towards a more innovation-driven environment for research and development (R&D) and market access in life sciences. This will, however, depend, to a great extent, on the practical impact and implementation of the other policy and legislative initiatives in the EU (e.g., the reform of the EU pharmaceutical legislation (see our latest blog), Biotech Act, Critical Medicines Act (see our blog)).

The Strategy presents concrete EU level actions to address long-standing challenges in life sciences in the EU, such as regulatory fragmentation across EU Member States, as well as the barriers to multi-country clinical trials and to the market access of advanced therapies and novel technologies.

A new Life Science Coordination Group within the European Commission will oversee the implementation of the Strategy and ensure that EU policies are consistent and supportive of innovation.

This blog highlights key elements of the Strategy of relevance to pharmaceutical, MedTech, and biotech companies.Continue Reading The European Commission Publishes an EU Life Sciences Strategy

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2025 from the United Kingdom and European Union.

There has been a flurry of new guidance from the Medical Device Coordination Group this month, including guidance on classification of medical device software, on supply of software apps through online platform such as the App Store and Google Play, and on the interaction between the Medical Device Regulation and the EU AI Act. These are welcome guidance documents to provide important clarification for manufacturers as they develop software medical devices, although the guidance documents inevitably cannot cover every situation and leave some questions unanswered. Continue Reading Virtual and Digital Health Digest – July 2025

The UK Government has recently published plans for the Life Sciences Sector and the NHS in England. In this blog post, we summarise these plans and some of the initial feedback that has been published by ABPI.  It is not surprising that there is a large amount of overlap between the two plans, albeit that the NHS 10 Year Plan is more rooted in the public sector. Both plans send a clear message: the Government recognises the vital role that life sciences companies must play in order to improve the UK’s standing as a centre for life sciences. The impact these plans will have on the Life Sciences industry, and whether they are enough to realise the Government’s ambitions, remains to be determined.Continue Reading The UK Government has plans: what does this mean for the Life Sciences Sector?

On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing Practice (GMP) guidelines—specifically Chapter 4 on Documentation, Annex 11 on Computerised Systems, and, for the first time, a new Annex 22 dedicated to AI.Continue Reading EU Consults on New GMP Rules for AI in Pharma Manufacturing

The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance)  introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance provides more detailed examples, specifically includes software using artificial intelligence (AI), and addresses modular software and interoperability with electronic health records (EHRs) under the European Health Data Space (EHDS).

This blog post outlines these key updates and considers their potential impact on compliance obligations for software manufacturers.Continue Reading Revised guidance on classification of Medical Device Software in the EU

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2025 from the United Kingdom and European Union.

There has been a lot of focus on AI this month. The European Commission has launched a consultation on high-risk AI systems, which includes medical devices and is therefore highly relevant for digital health companies. The European Medicines Agency has published a workplan on data and AI use, which sets out how the European Medicines Regulatory Network plans to leverage large volumes of regulatory and health data to support regulatory decision-making for better medicines. There has also been international guidance published on the use of AI in pharmacovigilance. However, there has also been controversy as the UK Data Use and Access Bill continues through the parliamentary process, as there is disagreement on its treatment of copyright-protected material in the development of AI systems. As uses of AI continue and authorities seek to put in place relevant legislation and guidance to match the speed of development, expect this focus to continue.Continue Reading Virtual and Digital Health Digest – June 2025