Volume 156, 28 October 2014, Pages 107–114
Review
Non-European traditional herbal medicines in Europe: A community herbal monograph perspective ☆
Abstract
Ethnopharmacological relevance
The
European Directive 2004/24/EC introducing a simplified registration
procedure for traditional herbal medicinal products, plays an important
role in harmonising the current legislation framework for all herbal
medicinal products in the European Union (EU). Although substantial
achievements have been made under the new scheme, only a limited number
of herbal medicinal products from non-European traditions commonly used
in Europe have been registered. Therefore, identification of the
obstacles, and determination of appropriate means to overcome the major
challenges in the registration of non-European traditional herbal
medicinal products are of critical importance for the EU herbal
medicinal product market.
Aims of the study
The
primary aims of this study were to understand the key issues and
obstacles to registration of non-European traditional herbal medicinal
products within the EU. The findings may identify the need for more
attention on the Community herbal monographs elaborated by the Herbal
Medicinal Products Committee (HMPC), as well as further evidence based
scientific research on non-European herbal substances/preparations by
the scientific community.
Methods
A
systematic evaluation of the herbal substances and preparations
included in Community herbal monographs and public statements has been
carried out. The focus was herbal substances and preparations derived
from non-European traditions.
Results
Of
the 109 adopted Community herbal monographs, 10 are herbal substances
used in Chinese traditional medicine. Where the HMPC issued a public
statement because it was unable to elaborate a monograph more than
half-involved herbal substances/preparations from non-European
traditions. The main reasons herbal substances/preparations from
non-European traditions were not accepted for inclusion in the Community
herbal monographs have been identified as due to unfulfilled
requirements of Directive 2004/24/EC. The most common reasons were the
lack of evidence to demonstrate a 15-year minimum medicinal use period
in the EU and evidence of absence of health risk as required by Article
16a (1) (d), and Article 16a (1) (e).
Conclusions
Under
the current EU legislation, the requirement to demonstrate 15-year
minimum medicinal use in the EU is a major obstacle to the registration
of non-European traditional herbal medicinal products. Access to
scientific data to support the product safety profile may be a possible
solution to overcome the hurdle presented by the 15-year minimum
medicinal use period.
Furthermore, the Community
herbal monographs play an important role in the registration process.
Therefore, making full use of existing Community herbal monographs, and
promoting scientific research and subsequent development of additional
monographs for herbal substances and preparations, and combinations
thereof from non-European traditions would be of benefit to herbal
medicinal product registration from non-European traditions.
Graphical abstract
Keywords
- Directive 2004/24/EC;
- European legislation of herbal medicinal products;
- Community herbal monograph;
- Non-European traditional herbal medicinal products
- ☆
- This work is supported by Chinese Twelfth Five-year Plan of Chinese Ministry of Science and Technology, project of the EU registration study of traditional Chinese medicine. Project number: 2012ZX09101231.
- Corresponding author. Tel.:
+86 2882855465; fax: +86 2882855223.
- 1
- W.J. Zou is associated with Chengdu Diao Pharmaceutical group Co., Ltd.; this company has potential commercial interest in this topic.
- 2
- M. Wang and J. van der Greef are associated with SU BioMedicine BV; this company has potential commercial interest in this topic.
