Politics

In this section you find regulatory issues on Clinical Trials.

Regulations and Guidances on Good Clinical Practice and Clinical Trials in the US can be found at http://www.fda.gov/oc/gcp/.

The European Union legislation in the pharmaceutical sector is supported by a series of guidelines: Volume 10 of the publications “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials.

Requirements for the conduct of clinical trials in the EU are provided for in the “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” (“The European Unions' Clinical Trials Directive”).

For detailed information about the EU legal framework in Clinical Trials, have a look at this website of the European Union.