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
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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
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
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
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
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
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
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
Notable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?
In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”).
UK to implement novel framework for point of care manufacture of medicinal products
On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the