Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

The manufacturing process is crucial for ensuring the safety and efficacy of traditional Chinese medicine(TCM) preparations. Using advanced technologies, innovative methods, and new equipment tailored for TCM to enhance the quality control of TCM preparations in the manufacturing process helps to ensure the product quality and foster high-quality development of the TCM industry. Upon current technical requirements, such as Guideline for Studies on Pharmaceutical Changes in Marketed Traditional Chinese Medicine Preparations(Trial) and Guideline for Study on Quality Control in Manufacturing Process of Oral Traditional Chinese Medicine Preparations(Trial), this paper analyzes the characteristics and current development of quality control in the manufacturing process of TCM preparations. It also discusses the significant roles that quality control in manufacturing process plays in ensuring the quality consistency and in the evaluation and decision-making of changes in marketed TCM preparations. Furthermore, to benefit the high-quality development of the TCM industry, this paper offers recommendations for improving quality control of TCM preparations in the manufacturing process and implementing new technologies and methods.
Quality Control ; Drugs, Chinese Herbal/chemistry* ; Medicine, Chinese Traditional/standards* ; Decision Making ; Humans

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

The scientific and standardized evaluation of clinical efficacy of traditional Chinese medicine(TCM) is the core requirement for promoting the high-quality development of TCM. Building a recognized evaluation outcome system that conforms to the clinical efficacy characteristics of TCM is a key fundamental issue in the production and transformation of clinical evidence in TCM. In response to the heterogeneity of evaluation outcomes and core issues such as "western law in the middle", the research on the core outcome set of TCM(COS-TCM) has undergone more than ten years of exploration and practice. Its methodological system has continued to deepen under the coordinated development of theoretical basis, technical methods, platform support, and talent team, achieving an important leap from early introduction to standardized system construction and entering a new stage of systematic development. However, the overall research scale, quality, and the translation and application of research results in COS-TCM are still insufficient. In response to the opportunities and challenges of the new development stage, this article systematically reviews the development history and research status of COS-TCM, clarifies the basic principles of "international standards + TCM characteristics" and the key tasks of "selection, improvement, and creation", and proposes a three-step development path of "exploration and research, standard development, and regulatory transformation" to promote the standardization, systematization, and scientific development of related research. To ensure the effective implementation of research results, key promotion strategies such as upgrading research platforms, strengthening support systems, and optimizing collaborative mechanisms have been planned to drive COS-TCM to better serve clinical research, evidence translation, and new drug review.
Medicine, Chinese Traditional/methods* ; Humans ; Drugs, Chinese Herbal/standards*

Traditionally, Dao-di herbs refer to high-quality traditional Chinese medicine(TCM) produced in specific geographical regions. The development of their assessment theory holds profound significance for ensuring the stability of clinical efficacy and advancing the heritage and modernization of TCM. The concept of assessing Dao-di herbs originated in the Eastern Han Dynasty. Through millennia of inheritance and evolving cognitive frameworks, the assessment system has progressed from the traditional "appearance-based quality assessment" rooted in material phenomenology to the modern "excellent shape, high quality, and superior effect" theory guided by scientific quantification. This evolution epitomizes the innovative integration of traditional wisdom and modern technology. The formation of the "excellent shape and high quality" characteristics in Dao-di herbs involves intricate multi-level biological processes. Molecular biology techniques alone exhibit limitations in this complex system. A paradigm shift from reductionism to systems theory is required, and multidisciplinary approaches should be integrated, including molecular biology, cell biology, biophysics, and systems biology. Future research should prioritize exploring cellular-level features, deciphering relationships between microstructure and function, and investigating how environmental conditions regulate these traits to form the "excellent shape and high quality" attributes. This study systematically reviews the developmental trajectory of Dao-di herbs theory and proposes a biomechanics-driven research framework incorporating cellular developmental principles, aiming to refine the "excellent shape, high quality, and superior effect" theory. Moving forward, research should align with clinical precision medicine demands, leveraging artificial intelligence(AI) to synergize "wet" experiments(elucidation of molecular mechanisms) with "dry" experiments(AI modeling). Data-driven approaches will advance the standardization of Dao-di herbs.
Drugs, Chinese Herbal/standards* ; Medicine, Chinese Traditional/methods* ; Humans ; China ; Plants, Medicinal/chemistry*

In order to support the implementation of the Opinions on Improving the Quality of Traditional Chinese Medicine and Promoting the High-Quality Development of the Traditional Chinese Medicine Industry and fundamentally promote the high-quality development of Chinese materia medica(CMM) industry, this article analyzed the quality and safety issues arising during the transition of CMM from wild harvesting to cultivation. Root causes of these issues were identified, including changes in the habitats of medicinal plants caused by inappropriate field cultivation patterns, excessive use of chemical inputs such as fertilizers and pesticides, and shortened cultivation periods due to rising economic costs. To address the above issues, the following countermeasures and suggestions were proposed to advance the high-quality development of CMM:(1) comprehensively adjust the cultivation patterns, vigorously promote ecological cultivation of CMM, and ensure production quality and safety of CMM from the source;(2) strengthen the breeding of high-quality, stress-resistant CMM varieties, improve cultivation techniques to reduce the use of fertilizers and pesticides, and improve the quality and efficiency of ecological cultivation of CMM;(3) systematically design the production, operation, and supervision models for ecological cultivation of CMM, carry out demonstrations of "high quality with fair price", and ensure the sustainable development of ecological cultivation of CMM.
Drugs, Chinese Herbal/standards* ; Quality Control ; Plants, Medicinal/chemistry* ; Plant Roots/chemistry* ; China ; Fertilizers/analysis* ; Materia Medica/standards* ; Medicine, Chinese Traditional/standards*

The guidelines for clinical research on new drugs provide unified standards for drug developers, researchers, and regulatory authorities, playing a crucial role in new drug development. This article systematically reviews the evolution of guidelines for clinical research on new traditional Chinese medicine(TCM) drugs in China, with a focus on analyzing the current status of these guidelines and the problems that exist. It also provides interpretations of three important guidelines. The article points out that with the continuous emergence of new clinical trial design methods, development concepts, and tools, and under the background of the "three combinations" evidence evaluation system for new TCM drugs, it is imperative to revise existing guidelines, formulate new ones, and develop new tools for clinical efficacy evaluation. It is hoped that relevant departments will adopt an open attitude and work together to build a technical system of clinical research guidelines for new TCM drugs that aligns with the characteristics of TCM.
Humans ; Biomedical Research/trends* ; China ; Clinical Trials as Topic ; Drugs, Chinese Herbal/therapeutic use* ; Guidelines as Topic ; Medicine, Chinese Traditional/standards*

Quality control is a key link in the modernization process of traditional Chinese medicine(TCM). Studies have shown that the effects of active components in TCM depend on not only their chemical composition but also their suitable physical forms and states. The physical phase structures, such as micelles, vesicles, gels, and nanoparticles, can improve the solubility, delivery efficiency, and targeting precision of active components. These structures significantly enhance the pharmacological activity while reducing the toxicity and side effects, demonstrating functional activity surpassing that of active components and highlighting the key effects of "structures" on "functions" of active components. Taking the physical phase structure as a breakthrough point, this paper outlines the common types of TCM physical phase structures. Furthermore, this paper explores how to realize the quality upgrading of TCM through the precise regulation of physical phase structures based on the current applications and potential of TCM physical phase structures in processing to increase the efficacy and reduce the toxicity, compounding and decocting processes, drug delivery systems, and quality control, aiming to provide novel insights for the future quality control of TCM.
Quality Control ; Drugs, Chinese Herbal/standards* ; Medicine, Chinese Traditional/standards* ; Humans ; Drug Delivery Systems

Traditional Chinese medicine(TCM) decoction pieces are a core carrier for the inheritance and innovation of TCM, and their quality and safety are critical to public health and the sustainable development of the industry. Conventional quality control models, while having established a well-developed system through long-term practice, still face challenges such as relatively long inspection cycles, insufficient objectivity in characterizing complex traits, and urgent needs for improving the efficiency of integrating multidimensional quality information when confronted with the dual demands of large-scale production and precision quality control. With the rapid development of artificial intelligence, machine learning can deeply analyze multidimensional data of the morphology, spectroscopy, and chemical fingerprints of decoction pieces by constructing high-dimensional feature space analysis models, significantly improving the standardization level and decision-making efficiency of quality evaluation. This article reviews the research progress in the application of machine learning in the processing, production, and rapid quality evaluation of TCM decoction pieces. It further analyzes current challenges in technological implementation and proposes potential solutions, offering theoretical and technical references to advance the digital and intelligent transformation of the industry.
Machine Learning ; Drugs, Chinese Herbal/standards* ; Quality Control ; Medicine, Chinese Traditional/standards* ; Humans