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 with six other government agencies. The Draft Management Measures were issued for public comment, with
Arnold & Porter Kaye Scholer LLP
With nearly 1,000 attorneys, Arnold & Porter provides sophisticated litigation to the life sciences and financial services industries across the globe. Their lawyers cover more than 30 practice areas including corporate finance, intellectual property, litigation, real estate, tax, and bankruptcy. With over 100 years of history, the firm offers clients forward-looking and client driven services to resolve their legal needs.
Website:
https://www.arnoldporter.com/
Arnold & Porter Kaye Scholer LLP Blogs
Latest from Arnold & Porter Kaye Scholer LLP
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 IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).
Following that publication, two…
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 medicines across the whole of the UK. The changes to the UK licensing regime will…
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 Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’).
This new reporting obligation is set out…
When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU
Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products?
Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers…
Virtual and Digital Health Digest – November 2024
This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.
Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government…
EU looks to facilitate development of “orphan” medical devices
The European Union has for the first time introduced measures to facilitate the development of medical devices for rare conditions, and has recently published the Medical Devices Coordination Guidance on the clinical evaluation of orphan devices (the MDCG Guidance). Key aspects of the document include defining “orphan devices” and guidance on their clinical evaluation, including…
The UK Innovative Licensing and Access Pathway (ILAP) to enter a new era
The current version of the Innovative Licensing and Access Pathway (ILAP) was first launched by the UK government in January 2021, shortly after the Brexit transition period came to an end. Its aim was to be a new, accelerated route to bring innovative medicines to the UK market, through facilitating a streamlined and efficient collaboration…
The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk
A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain,…
UK Government Publishes Draft Regulations on Medical Devices Post-Market Surveillance
On 21 October 2024, the UK Government laid before Parliament the draft statutory instrument setting out proposed new post-market surveillance (PMS) requirements for medical devices in Great Britain (the PMS SI). The PMS SI will significantly enhance the PMS requirements for manufacturers of medical devices placed on the market or put into service in Great…