On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices
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MHRA sets out its AI regulatory strategy
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024,…
The MHRA’s “AI Airlock” – what do you need to know?
In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot…
What you need to know about the FDA Laboratory Developed Test Final Rule
On 6 May 2024, the U.S. Food and Drug Administration (FDA) published its highly anticipated final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests…
Preparing for the implementation of the EU Health Technology Assessment Regulation
The EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January 2025 for oncology medicines, advanced therapy medicinal products and medical devices (the HTA Regulation will…
Getting Ready for the Upcoming Revised EMA CTIS Transparency Rules
The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System (CTIS), as adopted by the European Medicines Agency (EMA) on 5 October 2023, will come into effect on 18 June 2024, thesame day the…
Virtual and Digital Health Digest, April 2024
This digest covers key virtual and digital health regulatory and public policy developments during March.
You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product…
Brexit update: Changes to parallel imports in the UK
On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs)…
European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.
The vote is a key step in the passage of the new Directive and Regulation, which together form…
Commission Communication on biotechnology and biomanufacturing
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission…