Public Assessment of the Clinical Trials Directive

On 10 December 2008, the European Commission announced that the so-called "Clinical Trials Directive", Directive 2001/20/EC, should be assessed. It was thus communicated to the European Parliament and a number of committees. Now the results of the assessment are available, and have been published. On this topic, a public consultation has also been initiated. Until 8 January 2010, the interested parties, i.e. authorities, associations and the industry, can submit their comments on the document. It is the objective of this initiative to be able to consider different possibilities to further improve the Directive based on the feedback.

The document can be found here.
The Directive, which is officially called "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use", includes specific provisions for the conduct of clinical trials, especially with regard to the implementation of the Good Clinical Practice.

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

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