I.D.E.A. Ltd. (Innovative Drugs European Associates)

Enabling non-EU sponsors to perform clinical research in the European Union

The EU Clinical Trials Directive (Directive 2001/20/EC) was published on 4 April 2001 and all EU member states have now incorporated these provisions into national legislation.

This directive sets the legal framework for harmonising national laws and has created one of the largest potential opportunities for clinical research in the world. The legislation is based on Good Clinical Practice and aims to standardise the procedures and improve communication within the 27 member states. Article 19 of the Directive requires any Sponsor who is established outside of the EU (i.e. without a registered address in the EU) must have a Legal Representative, established within the EU.