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 December 2024 and early January 2025 from the United Kingdom, and European
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.
Latest from BioSlice Blog - Page 11
Chinese Regulators Publish Final Anti-Corruption Guidelines for the Healthcare Industry
On January 14, 2025, the State Administration for Market Regulation (SAMR, 国家市场监督管理总局) published the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Guidelines, 医药企业防范商业贿赂风险合规指引). The Guidelines are the final version of the Draft Compliance Guidelines for Healthcare…
New Year Update: incoming changes to UK regulation of clinical trials
2025 promises to be a year of further advancements in the UK’s life sciences sector and one important area of on-going development is the regulation of clinical trials.
After some delay, the much anticipated Medicines for Human Use (Clinical Trials)…
New Year, New UK-Wide Licensing Regime
On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring…
Virtual and Digital Health Digest – December 2024
Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and…
The European Commission launches public consultation on the MDR and IVDR
The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.
The Commission aims to assess the performance of the Medical Devices Regulation (MDR) and the In…
China’s New Draft Administrative Measures for Management of Medical Representatives
On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction…
FDA LDT Final Rule Litigation — Status and What May Happen Next
In our blog post from May this year, we set out what you need to know about the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture…
Windsor Agreement changes to UK Assimilated SPC Regulation
Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence…
Medical devices: European Commission issues Q&A on the obligation to notify supply interruptions and discontinuations
The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro…