A multi-case study on path suggestions for the internationalization of Chinese patent medicines based on grounded theory
10.3760/cma.j.cn115398-20231121-00245
- VernacularTitle:基于扎根理论的中成药国际化发展多案例研究
- Author:
Yinuo SUN
1
;
Rizhen WANG
;
Yuyang ZHANG
;
Yangmu HUANG
Author Information
1. 北京大学公共卫生学院全球卫生学系2021级硕士研究生，北京 100191
- Keywords:
Chinese patent medicines;
Internationalization;
Grounded theory;
Case analysis;
Path suggestions
- From:
International Journal of Traditional Chinese Medicine
2024;46(10):1271-1276
- CountryChina
- Language:Chinese
-
Abstract:
Due to multiple factors such as the closed research and development (R&D) system and differences in international mainstream regulatory standards, the internationalization of Chinese patent medicines has been weakly promoted. Multi-case analysis based on grounded theory can identify the key factors that promote the internationalization of Chinese patent medicines in each link, so as to put forward suggestions for promoting the internationalization of Chinese patent medicines. By retrieving the research literature on the internationalization of Chinese patent medicines included in CNKI, and further searching the official websites of the corresponding enterprises, as well as the news reports, comments and analysis of related events on official websites such as Xinhua News Agency, People's Network and China Medical Device Network, 27 textual materials were obtained, 6 classic cases of international registration of Chinese patent medicines were summarized, and three-level coding was used to organize and analyze them level by level. 25 initial categories and 7 main categories were extracted, and 4 core categories were finally summarized: promote R&D and promotion in advantageous areas based on international needs, build a quality control system in line with the international standards, select appropriate national markets based on international demand, and carry out international collaborative R&D in the whole life cycle. Based on this, suggestions were put forward: in order to promote the internationalization process of Chinese patent medicines, priority disease types and product formulations should be determined based on demand during the drug discovery phase; full cycle international cooperation in drug R&D should be carried out; a Chinese patent medicines and simple preparations supervision system that is in line with the international standards in the link of drug quality supervision should be constructed; countries with flexible and experienced regulatory rules in the drug approval and marketing process should be chosen.
