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.
BioSlice Blog
The BioSlice Blog, published by Arnold & Porter Kaye Scholer LLP, focuses on regulatory, legal, and policy developments in the life sciences sector. It covers topics such as medical device regulations, pharmaceutical legislation reforms, intellectual property frameworks in healthcare, and digital health innovations. The blog provides analysis on EU and UK regulatory changes, compliance challenges, and industry impacts, including discussions on breakthrough and orphan device pathways, notified body regulations, NHS IP guidance updates, and antimicrobial resistance measures. It also addresses litigation, transactional, and public policy issues relevant to biotech, medtech, and pharmaceutical companies operating in regulated markets.
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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 September and early October 2025 from the the United Kingdom, and European Union.…
Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]
[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.
Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method…
The Dog That Barks: The UK’s CMA is proposing major reforms to Veterinary Businesses
Following a two year investigation, the UK’s Competition and Markets Authority (“CMA”) has issued its provisional findings in which it proposes to impose significant obligations on veterinary business.…
MHRA and NICE launch aligned approvals pathway
On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline the…
CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines
On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to…
Article 22 Trends in Pharma M&A: Call-In Powers and Timing
Article 22 and the Pharma Context
Competition authorities in Europe have for years grown increasingly concerned about so-called “killer acquisitions,” particularly in life sciences where targets often have high innovation potential but little or no turnover. These are transactions where…
European Commission Publishes New Variation Guidelines for Medicines
The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations (“MA”) for medicinal products) (“Variations Guidelines”).
The new 2025 Variations Guidelines replace the older 2013 Variation Guidelines, and…
European Commission’s call for evidence on the revision of the MDR/IVDR
On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices…
UK government and pharmaceutical industry fail to reach agreement on amendments to medicines pricing scheme
The Association of the British Pharmaceutical Industry (ABPI) and the Department of Health and Social Care (DHSC) have confirmed that they have ended negotiations on amendments to the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The…