Basic information for International IITs

First ELN action: Impact assessment of the directive 2001/20/EC for stakeholders.
Deadline: January 08, 2010

The directive 2001/20/EC (Clinical-Trials-Directive on Good Clinical Practice) could be amended and the EC has started an impact assessment to evaluate the goals and functioning of the directive. Part of the assessment is a public consultation process, which was performed on behalf of the ELN and further EU projects and stakeholer groups. The commented paper presented here is clearly focusing on the poor situation of multinational therapy optimization trials (investigator-initiated trials) and highlighting necessary changes (see c).

You will find here the
a) link to the EC website with some general information on Directive General (DG) Enterprise and the directive and
b) direct link to the consultation paper
c) final statement of stakeholder (non-commercial sponsors) on behalf of the ELN.

The following link will also lead you to further commented papers. They will be made public available by DG enterprise and industry at their website.

A huge amount of international stakeholder groups has been acting in commenting the impact assessment of ct-directive. You will find corresponding documents following the link to the EC-Website.

Also a summary of the feedback as well a very short action-summary has been provided by DG Sanco (see below).

If you like to

• comment the general content of this part of the website,
• suggest specific content to the European and/or national issues,
• or name a national representative for your workpackage regarding the initiation and conduction of IITs

If you have any questions or suggestions, for example a specific document should be listed in the document collection, please contact ihrig@med.uni-frankfurt.de.