Advancing human-use experience for real-world evidence for the registration of traditional Chinese medicine products in China
HUE can be advanced to generate RWE for the safety and effectiveness of TCM products, which provides potential support for registering new TCM products. Leveraging HUE for registration can shorten research and development period, reduce development costs, and promote innovation, ultimately driving the growth of the TCM industry. However, several challenges remain in using HUE to support the registration of TCM products in China, including difficulties in data accessibility, lack of standardized protocols for HUE collection and reporting, and obstacles in transforming TCM preparations from hospitals into new TCM products using HUE. Furthermore, ensuring high-quality HUE requires future attention to data applicability, data infrastructure, and research design.
Authors
- Hao Hu (ORCID: https://orcid.org/0000-0001-9441-106X)
- Carolina Oi Lam Ung (ORCID: https://orcid.org/0000-0003-1915-5099)
- Xianwen Chen (ORCID: https://orcid.org/0000-0001-9262-2568)
- Yunfeng Lai (ORCID: https://orcid.org/0000-0002-2417-0253)
- Lina Zhu (ORCID: https://orcid.org/0000-0003-3453-3043)
- Yan Xue (ORCID: https://orcid.org/0000-0003-3343-8503)
- Sheng Han (ORCID: https://orcid.org/0000-0001-5975-3574)
- Meihong Xia
Institutions
- University of Electronic Science and Technology of China (CN)
- Peking University (CN)
- University of Macau (MO)
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN)
Publication Details
- Journal
- BMC Complementary Medicine and Therapies
- Published
- 2025-05-14
- DOI
- https://doi.org/10.1186/s12906-025-04906-x
- Citations
- 3
- Primary Topic
- Traditional Chinese Medicine Studies
- Type
- article
- Field-Weighted Citation Impact
- 7.14
Funders
- China Pharmaceutical University
- Universidade de Macau
- Fundo para o Desenvolvimento das Ciências e da Tecnologia
- Peking University