Clinical trials for medicines: Legislation

This section outlines the legislation that governs clinical trials.

Law books

 

EU legislation
The body of European Union legislation in the pharmaceutical sector is compiled in 'The rules governing medicinal products in the European Union' (external link). Volume 10 of this publication contains legislation and guidance documents applying to clinical trials. 

Links to relevant legislation concerning clinical trials are provided below:

Clinical Trials Directive
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (external link) on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Good Clinical Practice
Commission Directive 2005/28/EC of 8 April 2005 (external link) laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

Good Manufacturing Practice
Commission Directive 2003/94/EC of 8 October 2003 (external link) laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

Annex 13 of Volume 4 of The rules governing medicinal products in the European Union (external link) provides guidance on the GMP requirements (including labelling requirements) for investigational medicinal products.

Advanced therapy medicinal products
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 (external link) on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (external link)

Medicinal products for human use
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 (external link) on the Community code relating to medicinal products for human use.

Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council (external link) on the Community code relating to medicinal products for human use.


UK legislation

The Medicines for Human Use (Clinical Trials) Regulations 2004.
The Medicines for Human Use (Clinical Trials) Regulations 2004: SI 2004/1031 (external link)

The Regulations were amended in 2006, principally to implement the CGP Directive (2005/28/EC)
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006.
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 - SI 2006/1928 (external link)

A second amendment to the Regulations makes provisions for the inclusion of incapacitated adults in a clinical trial in emergency situations:

 The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006.

The Medicines for Human Use (Clinical Trials) Amendment Regulations (No.2) 2006 - SI 2006/2984 (external link)

In May 2008 the Regulations were further amended to make provisions for trials involving minors in emergency situations:

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 – SI 2008/941  (external link)


Useful links


Page last modified: 14 June 2010