ABSTRACT:
Modern pharmacopeial monographs for Traditional Medicines are needed to assess the quality of herbal products and better understand their pharmacological actions according to renewed scientific paradigms Strict specifications and quality controls are required for registration and international commerce of Traditional Medicines in many regulatory frameworks around the globe. The development of public specifications in the form of pharmacopeial monographs for the Herhal Medicines Compendium that can be freely adopted and/or adapted could facilitate international commerce and repistration. USP has recently developed similar monographs for complex botanical dietary supplements, and has extended that knowledge to the development of modern monographs for the Herbal Medicines Compendium. Interlaced requirements for identity, purity, content and absence of contaminants are necessary to provide a comprehensive picture of these items. Basic supporting information for such developments can be classified as validation data and historical data obtained on multiple authentic specimens from locations recognized by the traditional use. In addition, accompanying reference standards and other reference materials should be developed in collaborative studies to make possible the analytical determinations indicated in the monographs. The processes used by USP will be presented.