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...

EU Clinical Trials Regulation (536/2014): key requirements on authorisation, CTIS, data transparency, safety and ethics, with 2024–2025 updates and implications for UK sponsors

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note looks at Regulation (EU) 536/2014, the EU Clinical trials Regulation (CTR), which governs clinical trials in the EU.

It outlines the principal features of the CTR that trial sponsors and pharmaceutical businesses need to understand in practice and keep in view for compliance, and to keep abreast of. Taking effect on 31 January 2022, the CTR applies directly across every EU Member State and the EEA, marking the most significant overhaul of the EU’s clinical trial legal framework since 2001, and is now in force without exception. Its reach is truly global: any interventional study conducted even in part within an EU Member State or the EEA must follow this regime throughout the entire trial life cycle, at all times, from start to finish. Because the UK had exited the EU before it became operative, the CTR does not extend to Great Britain (ie England, Wales and Scotland); however, under the Northern Ireland Protocol, certain provisions apply in Northern Ireland. From 1 January 2025, the ‘Windsor Framework’ took effect, placing Northern Ireland back under the UK Medicines and Healthcare products Regulatory Agency’s regulatory remit for medicinal products, under UK oversight. While the CTR does not affect clinical...

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Eveline Van Keymeulen

Latham & Watkins

Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice. Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters. In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry. Ms Van Keymeulen is ranked in Chambers for Life...

Jeanne Fabre

Latham & Watkins

Jeanne Fabre is an associate in the Paris office of Latham & Watkins and a member of the firm’s healthcare and life sciences practice. She advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, market access, promotion and advertising, post-market obligations, contracts and general compliance matters. Ms Fabre has significant experience working in pharmaceutical companies. Since her Master’s in Life Sciences Law, she has worked for more than three years for several companies, both for local affiliates and parent companies. She was seconded for 18 months part-time to a pharmaceutical company specialising in rare diseases, and a further three months for another pharmaceutical company. During that time she advised on a wide range of day-today regulatory topics (such as...

Web page updated on 21/05/2026

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