Chinese herbal medicine in Europe: Regulatory situation, problems and perspectives

Herbal medicinal products are regulated in Europe under the drug law. If only health claims are stated, some may be considered as dietary supplements. For drug approval, efficacy, safety and quality have to be demonstrated. A special European regulation exists for traditional herbal medicinal products (Directive 2004/24/EC), which does not require clinical studies, but only 30 years of traditional use, out of them 15 years in Europe [1]. A committee for Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) currently prepares a list of traditional and well-established herbal drugs/preparations/combinations which can be used for drug approval in the European Union. Also Community monographs on herbal drugs or herbal drug preparations that may be used for full marketing authorisations of well-established herbal medicinal products or simplified registrations are elaborated by this committee. However, Chinese herbs have not been considered so far.

For all types of products, whether new, well established or traditional, quality needs to be demonstrated individually. Detailed instructions for the documentation of quality are specified in the Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/2005; 20.2.2006), the Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products (CPMP/QWP/2819/00 Rev. 1; 30.3.2006), the Guideline on Specifications: Test procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products (CPMP/QWP/2820/00 Rev. 1; 30.3.2006), and the Guideline on Stability Testing of Existing Active Substances and Related Finished Products' (CPMP/QWP/122/02).

Identity, purity, and content are obligatory to be tested. Therefore corresponding methods need to be developed, and monographs are elaborated for the European Pharmacopoeia [2]. Fingerprint analysis is the most appropriate approach to consider the complex composition of herbal products. Therefore, chromatographic techniques, like TLC, HPLC and GC are the methods of choice for quality control [3].

Keywords: Chinese herbal medicine, regulation, Europe, quality, efficacy, safety

References: [1] Silano M et al. (2004) Fitoterapia 75: 107–116

[2] Bauer R, Franz G (2010) Planta Med.76(17):2004–11

[3] Wagner H, Bauer R, Xiao PG, Chen JM (Eds.) (1996–2010).Chinese Drug Monographs and Analysis. Verlag für Ganzheitliche Medizin Dr. Erich Wühr GmbH, Kötzting