Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Clinical trial definition

What does Clinical trial mean? A clinical trial is a structured study in human participants to test a medicinal product, measuring whether it works (efficacy) and how safe it is, including identification of adverse reactions. In legal practice this covers trials of investigational medicinal products (IMPs) conducted under Good Clinical Practice (GCP), with defined sponsor and investigator duties, participant consent, regulatory authorisation and ethics approval. In England and Wales, Scotland and Northern Ireland, the term is defined in the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), as amended. It includes investigations intended to discover or verify the effects of one or more...

COVID-19 life sciences: UK and EU regulatory flexibilities on medicines, devices/PPE, clinical trials, inspections, supply, MDR delay, vaccines, R&D, funding and collaboration [Archived]

Published by a LexisNexis Life Sciences expert

Practice notes

ARCHIVED : This Practice Note has been archived and is not maintained.

Coronavirus (COVID-19) poses an unparalleled test to the global life sciences sector. UK and EU regulators are issuing frequently updated guidance as the situation develops, and are supporting research and development aimed at limiting the spread’s impact.

This Practice Note outlines how UK and EU authorities are responding in relation to:

clinical trials and regulatory inspections
maintaining continuity of supply for medicinal products and medical devices
deferral of the application of Regulation (EU) 2017/745 (consolidated 24.04.2020), the Medical Devices Regulation (MDR)

It also highlights major R&D initiatives across the UK and EU, and summarises European Commission guidance on collecting and transfusing convalescent COVID-19 plasma. For sector-specific developments and updates on coronavirus, see the Practice Notes: Coronavirus (COVID-19)—EU life sciences tracker [Archived] and Coronavirus (COVID-19)—UK life sciences tracker [Archived].

Medicinal products Regulatory framework adaptations

The Commission, the European Medicines Agency (EMA) and the European medicines regulatory network have released a Q&A document, also endorsed by...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Maria Isabel Manley

Sidley Austin

Maria Isabel ('Marie') Manley leads Sidley Austin's Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious. Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. She has particular experience on issues arising during the life cycle of medicinal products, including IP, advertising, product liability and competition.Marie has represented a number of the world's leading pharmaceutical companies in litigation before the EU and English Courts, as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), the National Institute for Health and...

Zina Chatzidimitriadou

Sidley Austin

ZINA CHATZIDIMITRIADOU advises life sciences and medtech clients on all aspects of product lifecycle management under UK and EU law. A former scientist, having worked in molecular biology research, Zina brings with her the ability to effectively understand the science. She has a particular focus on advising and speaking on regulatory protections and IP rights, cell and gene therapies, market access, digital health, and artificial intelligence.Zina’s practice covers the pharmaceutical, medical device, medtech, biotechnology, food, cosmetics, and novel products (such as cannabidiol or CBD) industries on both advisory and contentious matters. Zina also co-leads the industry benchmarking group, ctlegal, for clinical trials in the pharmaceutical industry....

Web page updated on 21/05/2026

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