On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous
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Arnold & Porter Kaye Scholer LLP Blogs
Latest from Arnold & Porter Kaye Scholer LLP
Proposal for Revision of EU Legislation on Packaging and Packaging Waste
The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted,…
EMA publishes first draft of reflection paper on the use of AI in the medicinal product lifecycle
On 19 July 2023, the European Medicines Agency (EMA) published a draft Reflection paper on the use of artificial intelligence (AI) in the lifecycle of medicines (the Paper). The Paper recognises the value of this technology as part of the…
Legislative change is afoot for clinical trials conducted in the UK
At the beginning of July, the MHRA published its 2023 – 2026 Corporate Plan, which highlights, amongst many other topics, the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the “stable and…
The Retained EU Law (Revocation and Reform) Act 2023 – Update
The Retained EU Law Bill is now an Act of Parliament, having received Royal Assent on 29 June 2023. In our blog, published at the end of last year, we explained the draft Bill’s key features. Since then,…
European Parliament Adopts Its Version of AI Act
On June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law. As we previously reported, the AI Act regulates…
New UK International Recognition Routes for Medicines
On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA…
Demystifying the UPC and the Unitary Patent
Answers to Some Common Questions
After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by…
BGMA refused permission for judicial review in relation to negotiation of the voluntary scheme
In a judgment handed down today, 10 July 2023, Mr Justice Turner refused permission for an application by the British Generic Manufacturers Association (BGMA) for judicial review of the refusal of the Secretary of State for Health and Social Care…
Latest Virtual and Digital Health Digest
We have finalised the latest installment of our Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May 2023 from the United States, United Kingdom, and European Union.
For…