Public Consultation on Draft Revision 3 of detailed Guidance for the Request for Authorisation of a Clinical Trial

The respective Clinical Trials Directive provides details regarding clincal trials like for example:

  • authorisation of the NCA
  • notification of substantial amendments
  • and declaration of the end of the trial

But the EU 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. They have now submitted a draft revision for public consultation of the existing 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.

The purpose of this document is to provide the necessary guideline to
concretise the requirements in EU Member States and contracting States of the European Economic Area for:

  • Authorisation of a clinical trial on a medicinal product for human use;
  • Notifications of substantial proposed amendments; and
  • Declaration of the end of the clinical trial.

Member States and persons requesting authorisation of a clinical trial, substantially amending a protocol of a clinical trial, and declaring the end of a clinical trials shall consider this guidance when applying Directive 2001/20/EC and its implementing acts and guidance.

Contributions should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu. Deadline for public consultation: 8 September 2009

The document is accessible here.

Source: European Commission, Enterprise & Industry, Pharmaceuticals, News

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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