From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline
Abstract Traditional Chinese medicine (TCM) has become a standardized medical system through systematic development across global healthcare practices. However, concerns persist regarding the safety, efficacy and quality of traditional medicinal products. Traditional Chinese medicine regulatory scie...
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| Format: | Article |
| Language: | English |
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BMC
2025-06-01
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| Series: | Chinese Medicine |
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| Online Access: | https://doi.org/10.1186/s13020-025-01152-8 |
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| author | Hua Hua Jian-Yuan Tang Jun-Ning Zhao Ting Wang Jun-Hua Zhang Jiang-Yong Yu Chang-Ming Yang Yan-Ling Ai Qiao-Xian Luo |
| author_facet | Hua Hua Jian-Yuan Tang Jun-Ning Zhao Ting Wang Jun-Hua Zhang Jiang-Yong Yu Chang-Ming Yang Yan-Ling Ai Qiao-Xian Luo |
| author_sort | Hua Hua |
| collection | DOAJ |
| description | Abstract Traditional Chinese medicine (TCM) has become a standardized medical system through systematic development across global healthcare practices. However, concerns persist regarding the safety, efficacy and quality of traditional medicinal products. Traditional Chinese medicine regulatory science (TCMRS) has emerged as an interdisciplinary field to address these challenges. This discipline integrates multidisciplinary knowledge to develop new tools, standards and approaches for systematic evaluation of benefit-risk profiles. This approach aims to ensure the quality, safety, and efficacy of TCM products, while also supporting the development of scientifically grounded regulatory frameworks that accommodate traditional medicine’s distinctive characteristics. Through comprehensive quality management from raw material sourcing to production processes and clinical validation, developing and adopting TCMRS is entrusted to significantly strengthen its regulatory oversight. This review examines the critical scientific challenges in the modernization process of TCM, analyzes the conceptual foundations of TCMRS, evaluates its pivotal role in pharmaceutical transformation, and highlights its essential function in preserving traditional knowledge while fostering therapeutic innovation. Key challenges for TCMRS implementation include reconciling traditional epistemologies with modern pharmaceutical paradigms, standardizing complex herbal formulations, and developing rigorous evaluation protocols for decoctions and compound preparations. The integration of advanced methodologies, including systems biology, network pharmacology, artificial intelligence, and nanotechnology, into regulatory frameworks, combined with enhanced international cooperation, remains a crucial strategy for tackling global public health challenges. Future development trajectories for TCMRS will prioritize lifecycle management strategies, technology-driven innovation systems, and global knowledge-sharing initiatives, propelled by advancements in life sciences and information technology. This evolution requires careful balancing of three fundamental elements: theoretical development in traditional medicine, integration of emerging technologies, and maintenance of regulatory system stability. It is crucial to innovate the working mechanisms of the TCMRS researcher alliance and the global policy-coordination mechanism for TCM regulation, enhance the conversion of basic disciplines into regulatory applications, and support the establishment of an excellent TCM regulatory system with scientific decision-making. These efforts are essential for promoting the high-quality development of the TCM industry and boosting its international influence and presence. |
| format | Article |
| id | doaj-art-fea731e978b24ba4aafd0c2efe018f21 |
| institution | Kabale University |
| issn | 1749-8546 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Chinese Medicine |
| spelling | doaj-art-fea731e978b24ba4aafd0c2efe018f212025-08-20T03:27:18ZengBMCChinese Medicine1749-85462025-06-0120111810.1186/s13020-025-01152-8From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging disciplineHua Hua0Jian-Yuan Tang1Jun-Ning Zhao2Ting Wang3Jun-Hua Zhang4Jiang-Yong Yu5Chang-Ming Yang6Yan-Ling Ai7Qiao-Xian Luo8Key Lab of Biological Evaluation of TCM Quality of the State Administration of Traditional Chinese Medicine, Translational Chinese Medicine Key Laboratory of Sichuan Province, Sichuan Institute for Translational Chinese MedicineSichuan Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese MedicineKey Lab of Biological Evaluation of TCM Quality of the State Administration of Traditional Chinese Medicine, Translational Chinese Medicine Key Laboratory of Sichuan Province, Sichuan Institute for Translational Chinese MedicineBeijing Research Institute of Chinese Medicine, Beijing University of Chinese MedicineState Key Laboratory of Chinese Medicine Modernization, Tianjin University of Traditional Chinese MedicineDepartment of Drug Registration (Department of Supervision and Administration of Traditional Chinese Medicine and Ethnic Minority Medicine), National Medical Products AdministrationCenter for Drug Evaluation, National Medical Products AdministrationChengdu University of Traditional Chinese MedicineMacau Centre for Research and Development in Chinese Medicine, State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of MacauAbstract Traditional Chinese medicine (TCM) has become a standardized medical system through systematic development across global healthcare practices. However, concerns persist regarding the safety, efficacy and quality of traditional medicinal products. Traditional Chinese medicine regulatory science (TCMRS) has emerged as an interdisciplinary field to address these challenges. This discipline integrates multidisciplinary knowledge to develop new tools, standards and approaches for systematic evaluation of benefit-risk profiles. This approach aims to ensure the quality, safety, and efficacy of TCM products, while also supporting the development of scientifically grounded regulatory frameworks that accommodate traditional medicine’s distinctive characteristics. Through comprehensive quality management from raw material sourcing to production processes and clinical validation, developing and adopting TCMRS is entrusted to significantly strengthen its regulatory oversight. This review examines the critical scientific challenges in the modernization process of TCM, analyzes the conceptual foundations of TCMRS, evaluates its pivotal role in pharmaceutical transformation, and highlights its essential function in preserving traditional knowledge while fostering therapeutic innovation. Key challenges for TCMRS implementation include reconciling traditional epistemologies with modern pharmaceutical paradigms, standardizing complex herbal formulations, and developing rigorous evaluation protocols for decoctions and compound preparations. The integration of advanced methodologies, including systems biology, network pharmacology, artificial intelligence, and nanotechnology, into regulatory frameworks, combined with enhanced international cooperation, remains a crucial strategy for tackling global public health challenges. Future development trajectories for TCMRS will prioritize lifecycle management strategies, technology-driven innovation systems, and global knowledge-sharing initiatives, propelled by advancements in life sciences and information technology. This evolution requires careful balancing of three fundamental elements: theoretical development in traditional medicine, integration of emerging technologies, and maintenance of regulatory system stability. It is crucial to innovate the working mechanisms of the TCMRS researcher alliance and the global policy-coordination mechanism for TCM regulation, enhance the conversion of basic disciplines into regulatory applications, and support the establishment of an excellent TCM regulatory system with scientific decision-making. These efforts are essential for promoting the high-quality development of the TCM industry and boosting its international influence and presence.https://doi.org/10.1186/s13020-025-01152-8Traditional Chinese medicineTraditional medicineModern medicineTraditional Chinese medicine regulatory scienceDrug regulationModernization of traditional Chinese medicine |
| spellingShingle | Hua Hua Jian-Yuan Tang Jun-Ning Zhao Ting Wang Jun-Hua Zhang Jiang-Yong Yu Chang-Ming Yang Yan-Ling Ai Qiao-Xian Luo From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline Chinese Medicine Traditional Chinese medicine Traditional medicine Modern medicine Traditional Chinese medicine regulatory science Drug regulation Modernization of traditional Chinese medicine |
| title | From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline |
| title_full | From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline |
| title_fullStr | From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline |
| title_full_unstemmed | From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline |
| title_short | From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline |
| title_sort | from traditional medicine to modern medicine the importance of tcm regulatory science tcmrs as an emerging discipline |
| topic | Traditional Chinese medicine Traditional medicine Modern medicine Traditional Chinese medicine regulatory science Drug regulation Modernization of traditional Chinese medicine |
| url | https://doi.org/10.1186/s13020-025-01152-8 |
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