Planta Med
DOI: 10.1055/s-0043-118534
Perspectives
Georg Thieme Verlag KG Stuttgart · New York

Quality Standards for Herbal Drugs and Herbal Drug Preparations – Appropriate or Improvements Necessary?

Reinhard Länger1, Erich Stöger2, Wolfgang Kubelka3, Keith Helliwell4
  • 1Austrian Medicines and Medical Devices Agency, Vienna, Austria
  • 2Plantasia GmbH, Oberndorf, Austria
  • 3Dept of Pharmacognosy, University Vienna, Austria
  • 4Ransom Naturals Ltd., Hitchin, Hertfordshire, United Kingdom
Further Information

Publication History

received 29 May 2017
revised 28 July 2017

accepted 14 August 2017

Publication Date:
29 August 2017 (eFirst)

Abstract

Standards for quality control as defined in the European Pharmacopoeia contribute significantly to a consistent and high quality of herbal drugs, herbal drug preparations, and herbal medicinal products. The minimum content of single plant constituents is considered of high relevance. Therefore, nearly all monographs on herbal drugs or herbal drug preparations contain an obligatory assay.

However, a critical evaluation of the data published for such assayed constituents reveals that in most cases these constituents have to be considered as purely analytical markers without correlation to quality or efficacy. Examples where the assay does not meet its objective support the need to adapt current quality standards. Moreover, the trend to increase the content of certain constituents may lead to significant modifications to traditional manufacturing processes.

In order to initiate a scientific discussion, the role of the assay in the context of quality requirements, quality documentation in the manufacturing process, safety, and efficacy is discussed and possible alternatives to the single marker assay are examined.