Review on the registration of herbal drugs in north America and Europe
10.3760/cma.j.cn115398-20230104-00029
- VernacularTitle:植物药在北美和欧盟的注册现状
- Author:
Yong TAN
1
;
Bo WEN
;
Jiayin WEI
;
Xiaoyu FENG
;
Yuwen XIA
;
Lin LIN
;
Longhui YANG
Author Information
1. 中国中医科学院中医临床基础医学研究所，北京 100700
- Keywords:
Herbal drugs;
International registration;
North America;
European Union
- From:
International Journal of Traditional Chinese Medicine
2024;46(2):162-167
- CountryChina
- Language:Chinese
-
Abstract:
International registration of herbal drugs is a necessary prerequisite for the internationalization of Chinese materia medica. North America and European Union occupy an important position in the world herbal drugs market, and their drug administration and quality supervision requirements are relatively complete and progressiveness. By summarizing the definition of herbal drugs in North America and European Union, combing and interpreting the relevant laws, regulations and policy documents, this article constructed the registration path of herbal drugs, and discussed the current status of market registration of herbal drugs in North America and European Union based on the examples of successful marketing of herbal drugs under current application and approval in overseas markets. This article believed that in the future, an internationally matched TCM quality standard evidence system should be built, clinical trials of TCM products in line with international standards should be carried out, standards that are the same or higher than international mainstream GMP should be developed, the registration path of TCM compounds should be explored, and professionals to establish an international registration application team should be recruited to provide theoretical and practical support for China's overseas registration of Chinese TCM products, promote TCM products to enter the world mainstream market, and achieve high-quality development of TCM internationalization.
