On 12 December 2023, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published the first version of the Union list of critical medicines (the list). Along with the list, the EMA published a
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.
Latest from Arnold & Porter Kaye Scholer LLP - Page 2
Virtual and Digital Health Digest and webinar
Spurred, in part, by the COVID-19 pandemic and the need for new ways to reach patients at home, 2023 saw a boom in digital technologies and healthcare solutions: one-stop-shop telemedicine platforms, app-based remote patient monitoring, direct-to-consumer online pharmacies, software-based medical…
New EU-level actions addressing shortages
On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines…
UK clinical trials – new notification scheme for lowest-risk clinical trials
EMA relaunches Policy 0070 on publication of clinical data for medicinal products for human use
In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public…
New UK International Recognition Framework for Medicines
We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the…
UK Government launches Innovative Devices Access Pathway (IDAP)
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…
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…