Medicinal products for human use

Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use

 
 

Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial.

Period of consultation

From 22 June 2009 to 8 September 2009.

Contributions to and results of the consultation

The following submitting parties requested their submission not to be published: Actogenix.

Below are the public responses to the above-mentioned public consultation:

Targeted stakeholders

Contributions are invited from all stakeholders related to clinical trials. Stakeholders who are not established within the European Union are equally invited to comment.

Objective of the consultation

The Clinical Trials Directive provides a regime of authorisation of the NCA, notification of substantial amendments, and declaration of the end of the trial, and exhaustively harmonises these aspects. The Commission is under an obligation to draw up detailed guidance to ensure that the format and content of the request for authorisation of a clinical trial are harmonised. A draft revision of the existing detailed guidance is being submitted for public consultation.

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: