EU Directives

Clinical Trials Directive (2001/20/EC)

What is the EUCTD?

The EUCTD is a legal document, published in 2001, which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted.

It includes medicinal trials with healthy volunteers and small scale or pilot studies.

Member States must transpose the EUCTD into national law. It was implemented into UK law in May 2004, as the Medicines for Human Use (Clinical Trials) Regulations 2004.

Why was the Directive introduced?

The Directive was introduced to simplify and harmonise the administration of clinical trials across the EU by establishing clear, transparent procedures.

It is hoped that this will create conditions for the effective coordination of trials across Member States.

What does the Directive say?

The Directive:

• Sets standards for the protection of clinical trials subjects, including incapacitated adults and minors
• Requires Member States to establish ethics committees on a legal basis
• Covers certain Licensing Authority procedures for commencing a clinical trial
• Lays down standards for the manufacture, import and labelling of investigational medicinal products (IMPs)

It also requires clinical trials to be conducted in compliance with the principles of good clinical practice (GCP). The Commission has only recently published a separate Directive laying down the GCP standards that must be followed, see below.

Good Clinical Practice Directive (2005/28/EC)

The GCP Directive supplements the EUCTD, strenthening the legal basis for requiring Member States to comply with the principles and guidelines of good clinical practice, as set out in the ICH GCP guidelines.

The Directive was adopted in April 2005 and Member States must introduce the necessary laws and administratice provisions to comply with it by 29 January 2006.

At present, it is unclear how it will be implemented in the UK.