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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front. Med.    2017, Vol. 11 Issue (1) : 32-47     DOI: 10.1007/s11684-016-0495-2
REVIEW |
Innovative development path of ethnomedicines: the interpretation of the path
Zhaoyun Zhu(),Dehuan Fu,Yali Gui,Tao Cui,Jingkun Wang,Ting Wang,Zhizhong Yang,Yanfei Niu,Zhennan She,Li Wang
Yunnan Institute of Materia Medica, Innovation and R & D Center of Yunnan Baiyao Group Co., Ltd., and Yunnan Province Company Key Laboratory for New Drug Research and Development of TCM and Ethnomedicines, Kunming 650111, China
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Abstract  

One of the primary purposes of the innovative development of ethnomedicines is to use their excellent safety and significant efficacy to serve a broader population. To achieve this purpose, modern scientific and technological means should be referenced, and relevant national laws and regulations as well as technical guides should be strictly followed to develop standards and to perform systemic research in producing ethnomedicines. Finally, ethnomedicines, which are applied to a limited extent in ethnic areas, can be transformed into safe, effective, and quality-controllable medical products to relieve the pain of more patients. The innovative development path of ethnomedicines includes the following three primary stages: resource study, standardized development research, and industrialization of the achievements and efforts for internationalization. The implementation of this path is always guaranteed by the research and development platform and the talent team. This article is based on the accumulation of long-term practice and is combined with the relevant disciplines, laws and regulations, and technical guidance from the research and development of ethnomedicines. The intention is to perform an in-depth analysis and explanation of the major research thinking, methods, contents, and technical paths involved in all stages of the innovative development path of ethnomedicines to provide useful references for the development of proper ethnomedicine use.

Keywords ethnomedicines      innovative development path      resource study      standardized development research      industrialization      internationalization     
Corresponding Authors: Zhaoyun Zhu   
Just Accepted Date: 05 January 2017   Online First Date: 21 February 2017    Issue Date: 20 March 2017
URL:  
http://academic.hep.com.cn/fmd/EN/10.1007/s11684-016-0495-2     OR     http://academic.hep.com.cn/fmd/EN/Y2017/V11/I1/32
Fig.1  Technology road map for the research on the experiences related to use of ethnomedicines.
Fig.2  Technology roadmap for the investigation of ethnic medicinal plant (animal) resources.
Fig.3  Technology roadmap for studies on the identification of ethnomedicines.
Fig.4  Technology roadmap for topics and projects of new drug studies.
Fig.5  Technology roadmap for a new drug study of ethnomedicines. The submission of application information of new drugs of ethnomedicines generally references the requirement of Attachment 1 in Provisions for Drug Registration Regulation: requirement for traditional Chinese medicine and natural medicine registration classification and reporting information.
Fig.6  Secondary development of ethnomedicines. The submission of application information of the secondary development of ethnomedicines generally references the requirement of Attachment 4 in Provisions for Drug Registration Regulation: requirement for supplementary application and registration matters and reporting information of drugs.
Fig.7  Diagram of ethnomedicine industry.
Fig.8  Technology roadmap for the internationalization of ethnomedicines. Abbreviations: CMC, Chemistry, Manufacturing and Control; BRM, botanical raw material; BDS, botanical drug substance; BDP, botanical drug product; GACP, Good Agricultural and Collection Practice; GLP, Good Laboratory Practice; CGMP, Current Good Manufacturing Practice; IND, Investigational New Drug; CRO, contract research organization; EOP2, end-of-phase II clinical trial; NDA, New Drug Application.
Fig.9  Construction of the research platform and cultivation of teams for ethnomedicines.
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[1] Zhaoyun Zhu,Ting Wang,Dehuan Fu,Yali Gui,Jingkun Wang,Tao Cui. Innovative development path of ethnomedicines: an overview of ethnomedicines in China[J]. Front. Med., 2016, 10(2): 166-177.
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