Regulation of herbal medicines.

摘要

I was puzzled by your Editorial "Strengthening the regulation of herbal medicines in Europe" (April 30, p 1466) in which you state that "The Directive requires all herbal medicinal products to meet standards of quality, safety, and efficacy before they can be registered and marketed in the European Union (EU)". However, the official guidance from the European Commission states: "The simplified procedure allows the registration of herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the Community".