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China’s evidence-based re-evaluation of traditional Chinese medicine injections

Nature Medicine (2026)Cite this article

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China is launching a nationally coordinated, evidence-based re-evaluation of its traditional Chinese medicine (TCM) injection sector, valued at over US$10 billion. TCM injections, industrialized in the 1950s, now have a central role in cardiovascular, neurovascular and inflammatory care. The new initiative — jointly issued in 2025 by the National Medical Products Administration, the National Health Commission and the National Administration of Traditional Chinese Medicine — aims to shift from empirical use toward a precision, safety-driven and efficacy-validated regulatory framework1.

At the core of the policy is a mandatory post-marketing research system that integrates regulatory oversight with real-world pharmacovigilance and confirmatory clinical science. The consultation document released on 9 October 2025 outlines the strategic direction, and the Center for Drug Evaluation (CDE) technical specification details how marketing authorization holders (manufacturers) must develop integrated evidence packages. These include safety surveillance, batch quality and stability, chemistry–manufacturing–controls (CMC) data and clinical effectiveness assessed under standardized endpoints1,2. Together, these instruments enable a proactive system to validate, refine or legally eliminate products that fail to meet contemporary evidence standards1,2.

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References

  1. National Medical Products Administration. Announcement on further promoting post-marketing research and evaluation of TCM injections (draft for comment). https://go.nature.com/4ryDz5V (2025).

  2. Center for Drug Evaluation. Technical requirements for post-marketing research and evaluation of TCM injections (draft for comment). NMPA https://go.nature.com/3K4Eiew (2025).

  3. World Health Organization. Global Traditional Medicine Strategy 2025–2034 (WHO, 2025).

  4. Wang, A. et al. JAMA Neurol. 80, 851–859 (2023).

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  5. Liu, F. et al. J. Ethnopharmacol. 353 (Part B), 120413 (2025).

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Acknowledgements

The authors are supported by the Four Batches Innovation Project of Invigorating Medical through Science and Technology of Shanxi Province (2022XM07), and the Shanxi Province Chinese Medicine Science and Technology special research project (2024ZYY2A023).

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Authors and Affiliations

  1. Neurology Department, The Affiliated Cardiovascular Hospital of Shanxi Medical University, Taiyuan, People’s Republic of China

    Chen Chen

  2. Academy of Medical Sciences, Shanxi Medical University, Taiyuan, People’s Republic of China

    Ziwei Hou

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  1. Chen Chen
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  2. Ziwei Hou
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Correspondence to Chen Chen.

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Chen, C., Hou, Z. China’s evidence-based re-evaluation of traditional Chinese medicine injections. Nat Med (2026). https://doi.org/10.1038/s41591-025-04122-7

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