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Category Archives: Life Sciences

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Where Are We Now? Digital Health in the UK in 2021: Updates

In Lexology’s Getting the Deal Through: Digital Health 2021 (UK) Latham & Watkins considers the key regulatory and transactional issues faced by market players and practitioners. By Frances Stocks Allen, Oliver Mobasser, Sara Patel, Mihail Krepchev, and Samantha Peacock The UK has an active digital health market comprising both the private and public sectors. Venture … Continue Reading

UK’s MHRA Seeks “Bold New Regulatory Regime” for Medical Devices and Diagnostics

The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. By Eveline Van Keymeulen, Ranulf Barman, Oliver Mobasser, and Frances Stocks Allen A 10-week consultation launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on the future regulation of medical devices, … Continue Reading

Where Are We Now? Digital Health in the UK in 2021

In Lexology’s Getting the Deal Through: Digital Health 2021 (UK) Latham & Watkins considers the key regulatory and transactional issues faced by market players and practitioners. By Frances Stocks Allen, Oliver Mobasser, Sara Patel, Mihail Krepchev, and Robbie McLaren The UK has an active digital health market comprising both the private and public sectors. Venture … Continue Reading

COVID-19: DHSC and MHRA Pave the Way for Increased Ventilator Production

UK companies interested in producing ventilators and other critical equipment may benefit from regulatory exemptions and use government product specifications. By Frances Stocks Allen and Oliver Mobasser On 16 March 2020, Prime Minister Boris Johnson called on the UK’s leading manufacturing businesses to help the UK step up production of vital medical equipment to combat … Continue Reading

New EU Medical Devices Regulation to Be Postponed Until 2021

European Commission proposes one-year postponement in light of the COVID-19 crisis. By Frances Stocks Allen and Oliver Mobasser On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the new EU Medical Devices Regulation (MDR)[i] for one year, in light of the COVID-19 … Continue Reading

Green Shoots for the Commercialisation of Cannabis-Based Medicinal Products in the UK?

By Frances Stocks Allen and Oliver Mobasser Recent legal and regulatory developments pave the way for an increased commercialisation opportunity in cannabis-based medicines, but complex rules require careful navigation. The National Institute for Health and Care Excellence (NICE) recommended the reimbursement of two plant-derived cannabis products for the first time on 10 November 2019. This … Continue Reading

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. By Frances Stocks Allen, Oliver Mobasser, Héctor Armengod, Gail E. Crawford, Christoph W.G. Engeler, Robbie McLaren, and Henrietta J. Ditzen The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a significant volume of … Continue Reading
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