The GCP Guideline of the European Community on the performance of clinical trials became obligarory in June 1991.
As the GCP standards have mainly been set for innovative drugs, there is a certain danger that these criteria could not be fulfilled by medicines used in phytotherapy.
As regards, the chances and risks of the European guideline, especially for herbal medicines, the differences between chemically-defined and herbal drugs, as well as the extent, to which herbal medicines might be concerned by the guideline, have to be taken into account.
Herbal medicines are different from chemically defined medicines in their character as well as in their medicinal use.
They always contain a mixture of numerous substances.
Mots-clés Pascal : Phytothérapie, Pharmacognosie, Traitement, Facteur risque, Législation, Recommandation, Plante médicinale, Extrait, Origine végétale, Essai clinique, Ethique, Allemagne, Europe
Mots-clés Pascal anglais : Phytotherapy, Pharmacognosy, Treatment, Risk factor, Legislation, Recommendation, Medicinal plant, Extract, Plant origin, Clinical trial, Ethics, Germany, Europe
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0478593
Code Inist : 002B02A04. Création : 199406.