Implementation of directive 2001/20/CE in Spain: a historical opportunity for clinical research sponsored by co-operative groups

• Autores: Esther Mahillo Ramos
• Localización: Revista de oncología: Publicación oficial de la Federación de Sociedades Españolas de Oncología y del Instituto Nacional de Cancerología de México, ISSN 1575-3018, Vol. 5, Nº. 9, 2003, págs. 537-544
• Idioma: español
• Texto completo no disponible (Saber más ...)
• Resumen

  • After a long policy process, the European Directive 2001/20/CE on the approximation of 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 was published on 1 May 2001. Its main objective was to harmonise regulatory procedures and the level of patient protection throughout Europe. Two years after its publication, Authorities have delayed its implementation in their respective countries, pharmaceutical companies are concerned about confidentiality of their data, and investigators and co-operative groups feel that this Directive creates additional difficulties for the continuity of clinical trials sponsored by them.After a long policy process, the European Directive 2001/20/CE on the approximation of 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 was published on 1 May 2001. Its main objective was to harmonise regulatory procedures and the level of patient protection throughout Europe. Two years after its publication, Authorities have delayed its implementation in their respective countries, pharmaceutical companies are concerned about confidentiality of their data, and investigators and co-operative groups feel that this Directive creates additional difficulties for the continuity of clinical trials sponsored by them.After a long policy process, the European Directive 2001/20/CE on the approximation of 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 was published on 1 May 2001. Its main objective was to harmonise regulatory procedures and the level of patient protection throughout Europe. Two years after its publication, Authorities have delayed its implementation in their respective countries, pharmaceutical companies are concerned about confidentiality of their data, and investigators and co-operative groups feel that this Directive creates additional difficulties for the continuity of clinical trials sponsored by them.After a long policy process, the European Directive 2001/20/CE on the approximation of 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 was published on 1 May 2001. Its main objective was to harmonise regulatory procedures and the level of patient protection throughout Europe. Two years after its publication, Authorities have delayed its implementation in their respective countries, pharmaceutical companies are concerned about confidentiality of their data, and investigators and co-operative groups feel that this Directive creates additional difficulties for the continuity of clinical trials sponsored by them.After a long policy process, the European Directive 2001/20/CE on the approximation of 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 was published on 1 May 2001. Its main objective was to harmonise regulatory procedures and the level of patient protection throughout Europe. Two years after its publication, Authorities have delayed its implementation in their respective countries, pharmaceutical companies are concerned about confidentiality of their data, and investigators and co-operative groups feel that this Directive creates additional difficulties for the continuity of clinical trials sponsored by them.