Draft Commission Directive Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of Manufacturing or Importation Of Such Products
Brussels, Belgium: European Commission, 2004 June 14; 14 p. [Online]. Available: http://pharmacos.eudra.org/F2/pharmacos/news/DirectiveGCP20040614 .pdf [2004 November 16]
This proposed directive redrafts the original European Union clinical trials directive (2001/20/EC) that was developed to govern approval and monitoring of commercially-sponsored clinical research in countries of the European Union. This directive recognizes that clinical drug trials may be sponsored by non-drug companies and offers some different guidelines to govern non-commerical, non-profit research.
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Commission Directive 2005/28/EC of 8 April 2005 Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of The Manufacturing or Importation of Such Products Unknown author (Commission of the European Communities, 1995-04-09)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use Unknown author (1997)