European Clinical Trials Directive

The EU Clinical Trials Directive (Directive 2001/20/EC) was published in April 2001 with the requirement that each member state incorporate it into national legislation by 1 st May 2004 .
The full text of the EU Clinical Trials Directive can be found here . The implementing texts can be found here http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/dir200120ec.htm

The Directive applies to the majority of clinical trials involving medicinal products and creates a standard legal, regulatory and ethical framework for clinical research in Europe , which:

• Simplifies and harmonises the administrative procedures for the conduct of clinical trials throughout Europe
• Protects the rights, safety and well-being of clinical trial subjects

Hyperphar believes that the Directive will have a positive effect on clinical trials in Europe , by reducing bureaucracy, creating greater consistency and guaranteeing standard approval times.

For additional regulatory information, please refer to our Useful Links page on this website.
Click here for links to the Heads of Agencies for the whole of Europe.