The EU Clinical Trials Regulation

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins

Practice notes

The EU Clinical Trials Regulation

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins

Practice notes

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This Practice Note looks at Regulation (EU) 536/2014, the EU Clinical trials Regulation (CTR), which governs clinical trials in the EU. It discusses the key aspects of the CTR that clinical trial sponsors and pharmaceutical companies must be aware of.

The CTR, which became applicable on 31 January 2022, is directly effective in all EU Member States and the EEA and introduced the biggest change to the legal framework surrounding clinical trials in the EU since 2001. The CTR will have a global impact as all interventional trials which take place even partially in an EU Member State or the EEA will need to comply with its regulatory regime, at every stage of the trial life cycle.

As the UK had already left the EU when the CTR became applicable, it does not apply in Great Britain (ie England, Wales and Scotland) but, due to the Northern Ireland Protocol, parts of the CTR apply in Northern Ireland. On 1 January 2025, a new arrangement called

Eveline Van Keymeulen

Partner, 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 Sciences Regulatory (since 2020) and recognised as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (since 2018). She is considered a National and Global Leader by Who’s Who Legal Life Sciences (since 2016) and is further recognised as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021 and Euromoney’s Women in Business Law Expert Guide 2021. Ms Van Keymeulen was also recognised as European Advisory Lawyer of the Year (2021) by, and won Impact Deal of the Year at, the prestigious Europe LMG Life Sciences Awards (2021-2022). Clients particularly value her “high level of energy”, and appreciate her for “being extremely flexible and genuinely engaged” as well as having a “can do attitude” while some have even called her a “rockstar”.

Ms Van Keymeulen has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. Ms Van Keymeulen also serves on the editorial board of the European Pharmaceutical Law Review. In addition, Ms Van Keymeulen has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos and other leading international business journals on life sciences regulatory and policy matters.

Jeanne Fabre

Associate, 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 observational, (former) ATU and post-ATU studies, contractual relationships with service providers, consultancy and pay for performance agreements and pricing and reimbursement topics).

Jurisdiction(s):

United Kingdom

Key definition:

Clinical trial definition

What does Clinical trial mean?

An investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie, it assesses a medicine’s efficacy and safety.

The EU Clinical Trials Regulation

Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins