The most significant contribution of fingerprinting technology to the advancement of modern Chinese medicine research and quality control lies in its ability to develop comprehensive models that best represent the complex chemical composition of traditional Chinese medicines. These models are not only scientifically robust but also increasingly recognized by the international community, including regulatory bodies like the U.S. FDA. However, challenges remain—particularly in the limited progress made in understanding spectral and structural effects. To address these issues, experts suggest integrating both overall characterization and specific features of TCM treatments into a drug efficacy testing method. Strengthening research in bioinformatics, including chemometrics, is essential. By doing so, it becomes possible to establish a unique quality standard system for Chinese medicines that differs fundamentally from Western pharmaceutical standards. Such a system is within reach, and many believe it will revolutionize how TCM is perceived globally. Since 1993, China has actively pursued the modernization of traditional Chinese medicine. In 1998, the "Strategy for the Modernization of Traditional Chinese Medicine" was introduced, followed by the "Modernization of Traditional Chinese Medicine and Industrialization Development" special project in 1999. The "Outline for the Development of Traditional Chinese Medicine Modernization (2002–2010)" further guided this effort. Over the years, research institutes and enterprises have adopted various high-tech approaches, driving innovation and development in the field. During the "Tenth Five-Year Plan," the government launched a major science and technology project focused on "Innovative Drugs and Modernization of Traditional Chinese Medicine." This initiative integrated biomedical engineering, biology, and new drug development, accelerating the industrialization of Chinese patent medicines, advanced technologies, and herbal extracts. Significant investments in R&D have been made, with enterprise R&D costs rising from 1.62 billion yuan in 2001 to 4.34 billion yuan in 2005. Innovative drug research has yielded remarkable results: 45 patents were awarded for major projects, 41 varieties completed research and applied for new drug certificates, and 109 entered clinical trials. Additionally, 206 promising candidates are in early stages of clinical research. Notable examples include safflower yellow injection, Danshen polyphenol powder injection, and saffron yellow freeze-dried powder injection. The modernization of TCM has evolved through three key stages. The first involved reformulating traditional dosage forms using modern pharmaceutical techniques, transforming pills, powders, and ointments into tablets, capsules, and injections. The second stage focused on extraction and separation technologies to isolate active ingredients and remove ineffective components. The third stage involves applying advanced detection methods, high-throughput screening, and bioinformatics to achieve a clear understanding of TCM’s mechanisms and compositions. Despite progress, controversies persist, especially regarding safety concerns surrounding TCM injections. Experts warn that the modernization of TCM stands at a critical crossroads. Quality control remains a major challenge, with ongoing efforts to improve national standards and ensure safety and efficacy. Luo Guo'an, director of the Center for Modernization of Traditional Chinese Medicine at Tsinghua University, highlights three main difficulties in building a reliable quality standard system: creating a model accepted internationally, ensuring it reflects both chemical composition and therapeutic effects, and making it practical for production. Fingerprinting technology, combined with multi-indicator components, has already shown promise, as seen in Qingkailing Injection, where adverse reactions dropped significantly after implementing fingerprint-based quality control. Ultimately, the future of TCM lies in developing a scientific, internationally acceptable quality system that truly reflects its complexity and effectiveness. With continued innovation and research, this goal is becoming increasingly attainable.

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