Development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products - Scientific guideline

This document addresses the need of the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products.

Keywords: Herbal medicinal product, quality control, DNA-based technologies, NMR, UV/MIR/NIR spectroscopy, chemometric methods, biosensors

Current version

Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products

Draft: consultation closed Consultation dates: 31/10/2017 to 30/04/2018 Reference Number: EMA/HMPC/541422/2017 Corr. Summary:

Quality control is a prerequisite to assure safe and effective use of (traditional) herbal medicinal products, which are complex mixtures of numerous phytochemical constituents. For the majority of herbal substances, herbal preparations and (traditional) herbal medicinal products the active constituents are not known or are only partly understood.