Entries by Maria Isabel Manley

31 07 '25

UK proposes to extend transitional chemical registration deadlines under UK REACH

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GB based Chemical manufacturers or importers that relied on EU REACH registrations to continue marketing their products in Great Britain following Brexit have until 8 September 2025 to respond to a UK Government consultation on proposed revised transitional registration deadlines under UK REACH. Marie Manley and Victoria Kerr explain the background to the consultation, and why stakeholders should consider engaging with it.

15 07 '25

UK Life Sciences Sector Boosted By Raft Of New Policy Measures

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A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data Research Service.

29 10 '24

European Court of Justice Judgment Relating to Orphan Market Exclusivity

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In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.

26 06 '24

Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors

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Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.

29 05 '24

Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform

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The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process. 

11 04 '24

New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework

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Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.