The ICO recently announced its plan to bring the UK’s top 1,000 websites into compliance with applicable data protection law, in relation to their use of cookies. At the time of the announcement, the ICO had already checked 200 websites,
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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European Commission Publishes Proposal for EU Critical Medicines Act
On 11 March 2025, the European Commission published a proposal for a Critical Medicines Act (CMA).
The CMA introduces measures to improve the security of supply chains and availability of critical medicinal products and medicinal products of common interest in…
EU announces pilot coordinated assessment for clinical investigations of medical devices
On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European…
European Health Data Space Regulation Published in the EU Official Journal
On 5 March 2025, Regulation 2025/327 (EHDS Regulation), creating a European Health Data Space (EHDS), was published in the European Union Official Journal (EU Official Journal), marking the end of the legislative process of the EHDS Regulation.
As set out in…
UK Health Research Authority GDPR wording template to be used from 1 April
Clinical research studies within the NHS in England and Wales require Health Research Authority (HRA) approval, which brings together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). The HRA…
The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies
On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).
The aim of the…
Virtual and Digital Health Digest – February 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 January and early February 2025 from the United States, United Kingdom, and…
Online pharmacies required to strengthen safeguards to prevent unsafe supply of medicines in the UK
The UK’s General Pharmaceutical Council (GPhC) has published new guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. The GPhC is the pharmacy regulator for Great Britain. Pharmacies and pharmacists, including those operating online, are…
Proprietary Association of Great Britain (PAGB) updated Professional Code for Medicines
PAGB published its updated Professional Code for Medicines (the Code) on 12 February 2025.
PAGB is the UK trade association that represents manufacturers of branded over the counter (OTC) medicines, self-care medical devices and food supplements. PAGB publishes two codes:…