Medicinal products

Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC


Period of consultation

From 9 February 2011 to 13 May 2011.

Contributions to and results of the consultation

A summary of the responses is available here.

The following submitting parties requested their submission not to be published: Alexion, Biogen, Arbeitsgruppe Arzneimittel- Apotheken-, Transfusions- und Betäubungsmittelwesen (AG AATB), "National Institute for Health Research - Clinical Research Network Coordinating Centre", University of Bristol.

Below are the public responses to the abovementioned public consultation:

Objective of the consultation

The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.

This concept paper is being put out for public consultation. It presents:

  • A "preliminary appraisal" of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and
  • The main figures that are being used to evaluate the impacts of the different policy options.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: