The following Life Sciences practice note produced in partnership with Maria Isabel Manley of Sidley Austin, Zina Chatzidimitriadou of Sidley Austin and Sidley Austin provides comprehensive and up to date legal information covering:
Coronavirus (COVID-19) presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators are working to provide continually reviewed up-to-date guidance in response to the evolving crisis, as well as to support research and development (R&D) that they hope will contain the impact of the spread.
This Practice Note provides guidance as to the response of UK and EU regulators in the areas of clinical trials, inspections and the continuity of supply in medicinal products and medical devices, as well as the postponement of the implementation of Regulation (EU) 2017/745 (consolidated version 24.04.2020), the Medical Devices Regulation (MDR). It also summarises key R&D initiatives at a UK and EU level and European Commission guidance on the collection and transfusion of convalescent COVID-19 plasma.
For a summary of developments and updates on coronavirus that relate to the life sciences sector, see Practice Notes: Coronavirus (COVID-19)—EU life sciences tracker and Coronavirus (COVID-19)—UK life sciences tracker.
The Commission, the European Medicines Agency (EMA) and the European medicines regulatory network have published a Question and Answer (Q&A) document, also endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, providing guidance on regulatory expectations for
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