New Edition of the Herbal Guide

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published a new edition of the Guide for the elaboration of monographs on Herbal Drugs and Herbal Drug Preparations. The Guide provides general guidance on the structure of monographs of herbal drugs and herbal drug preparations in the European Pharmacopoeia (Ph. Eur.) and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

2nd edition

The updated guide replaces the 1st version published in 2005 and has been completely revised. New pharmacopoeial monographs and texts as well as new methods have been included in the revision. For example, the sections on "Assay" and "Herbal Drug Preparations" have been thoroughly revised and expanded. In addition, the guide also includes new and useful information such as a drawing of the characteristic microscopic features of powdered herbal drugs and a section on identification by HPTLC. A new section related to the recently introduced general chapter 2.8.26. Contaminant pyrrolizidine alkaloids has also been added.

Applicable Ph. Eur. General Monographs

General Ph. Eur. monographs which apply in addition to individual monographs on herbal drugs and herbal drug preparations are the following:

  • Herbal Drugs
  • Herbal Drug Preparations
  • Essential Oils
  • Herbal Drug Extracts
  • Herbal Teas
  • Herbal Teas, Instant

A general Ph. Eur. monograph usually describes requirements that must be fulfilled, not only for substances or preparations covered by an individual Ph. Eur. monograph but for all substances or preparations within the scope of the Definition section. For example, standard tests and labelling requirements are included in the general monograph Herbal Drug Extracts, and these are applicable to all monographs on extracts unless otherwise indicated.

The Guide for the elaboration of monographs on herbal drugs and herbal drug preparations is available on EDQM's Ph. Eur. Technical Guides website.

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