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.

You will find here the

1. link to the EC website with some general information on Directive General (DG) Enterprise and the directive
2. direct link to the consultation paper
3. 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.

European/all countries

• Amendment on 2001/20/EC: directive for the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Paper to comment (133KB)

2001/20/EC to comment

2001_20_EC_ConsultationPaper_Final-V2.pdf (67KB)

2001_20_EC_ConsultationPaper_Final-V2.pdf