Research Strategy on the Standard Route of Overseas Registration of Traditional Chinese Medicine Formulations
- VernacularTitle:中药成方制剂海外注册路径研究
- Author:
Lin LIN
1
;
Yong TAN
;
Bo WEN
;
Jiayin WEI
;
Xiaoyu FENG
;
Xiangpeng WANG
;
Yuwen XIA
;
Longhui YANG
Author Information
- Keywords: Traditional Chinese medicine; Prescription preparation; Overseas registration; Path; Strategy
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(3):557-563
- CountryChina
- Language:Chinese
- Abstract: Objective To explore the ideas,methods and pathways for the registration of Chinese medicine prescriptions in overseas countries,to form a strategy for overseas registration of Chinese medicine,and to provide technical support and reference for China's Chinese medicine prescriptions to go abroad.Methods Five representative countries were selected to form corresponding expert teams and exchange platforms for international cooperation.The laws,regulations,rules,standards,specifications and technical guidance documents related to Chinese medicine prescription preparations of the target countries were used as pathway research materials,and the documents were translated directly,naturalized,proofread and diagrammed,and a problem-oriented mechanism for consultation with domestic and international experts was established to form a pathway for overseas registration of Chinese medicine prescription preparations.Results The path for standardization of overseas registration of Chinese medicines was clarified,and the detailed registration paths and corresponding work strategies of Chinese medicines in five countries were formulated with flow charts,tables and explanatory texts.Conclusion By developing standardized registration pathways for traditional Chinese medicine in target countries,reference can be provided for the internationalization of Chinese herbal formula preparations.
