Abstract
In France, all phytopharmaceuticals are subject to general drug regulations. The validity of our ancestors’ empirical notions on herbal remedies must be tested by scientific analysis for retaining therapeutical use of these drugs. As for chemical or biological medicines, phytopharmaceutical drugs must comply with criteria of quality, safety and efficacy. Old herbal drugs have to be reviewed. New phytopharmaceuticals have to be explored and assessed on chemical, toxicological, and clinical scientific bases. Their pharmacological activity must be situated amongst existing medicines according to the therapeutic claims. Since 1980, experts from the French Pharmacopoeia Committee and the French Licensing Committee have done a great deal of research and selection to set the relevant requirements. First of all, I shall present the legal framework for the use of phytophamaceutical drugs in France, and then go through some practical problems of quality with French Pharmacopoeia and licensing of these drugs.
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