Volume 158, Part B, 2 December 2014, Pages 498–502
Regulation of herbal and traditional medicinal products – European and global strategies (International Symposium TradReg2013)
Abstract
Since
2004 the regulatory framework within the European Union has a specific
assessment procedure for herbal medicinal products, with a medicinal use
based on traditional practice. The main requirement concerning the
traditional use is focussed on the period of time for medical use: at
least 30 years, including 15 years in the EU. In addition to
requirements for quality and safety, an evaluation of pharmacological
effects or efficacy based on long-standing use, is a main objective.
“Traditional Use” however encompasses European, and non-European
traditional use. Outside the EU, the medicinal use of herbal substances,
-preparations, and –combinations is well-known, with a long history,
which is well-documented in the different systems of medical practice.
This has been addressed by WHO, but it has been acknowledged also by
European Commission that herbal products from other systems of medicine,
can be subject to the procedure for traditional herbal medicinal
products. This paper will focus on the possibilities, restraints, and
challenges of regulatory practice in the European Union regarding these
category of medicinal products.
Graphical abstract
Abbreviations used
- ANVISA, Agência nacional de vigilância sanitária, Brazil;
- EMA, European medicines agency;
- EU, European union;
- HMPC, Committee on herbal medicinal products;
- HAS, Health science authority, Singapore;
- PDMA, Pharmaceutical and medical devices agency, Japan;
- TCM, Traditional chinese medicine;
- WHO, World health organization
Keywords
- Traditional herbal medicinal products;
- Committee on herbal medicinal products;
- Community herbal monographs;
- Ayurveda;
- Traditional chinese medicine
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