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European requirements for clinical trials

Clinical trials

Organisations conducting clinical trials in the European Union must, if they wish to obtain marketing authorisation, respect the requirements for the conduct of clinical trials which can be found in the Clinical Trials Directive (“Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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”).

Guidelines to ensure that clinical trials are carried out in accordance with good clinical practice are contained in the “Commission Directive 2005/28/EC of 8 April 2005 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” (also known as the Good Clinical Practice or GCP for short). This document provides more concrete guidelines and lends further support to the Clinical Trials Directive.

In addition, the European Medicines Agency (EMA) has published additional, more specific guidelines which must also be respected. These include guidelines on inspection procedures and requirements related to quality, safety and efficacy.

Copies of the above-mentioned documents in 22 languages can be found at:



Last Updated: Tuesday 11 June 2019