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Directive 2001/20/EC

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

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This Directive aims at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.

The Articles of the Directive:

Scope (Directive does not apply to non-interventional trials).
Definitions
Protection of clinical trial subjects
Clinical trials on minors
Clinical trials on incapacitated adults not able to give informed legal
Ethics Committee
Single opinion
Detailed guidance
Commencement of a clinical trial
Conduct of a clinical trial
Exchange of information
Suspension of the trial or infringements
Manufacture and import of investigational medicinal products
Labelling
Verification of compliance of investigational medicinal products with good clinical and manufacturing practice
Notification of adverse events
Notification of serious adverse reactions
Guidance concerning reports
General provisions
Adaptation to scientific and technical progress
Committee procedure
Application
Entry into force
Addressees

The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.