I. The purpose and significance of the formulation of the Special Provisions on the Administration of Standards for Traditional Chinese Medicines

　　Drug standards are an important foundation for ensuring the safety and effectiveness of drugs, the benchmark for drug regulation and an important manifestation of a nation's level of pharmaceutical industry development and regulation. In the modernization and construction of the drug regulatory system and capacity, drug standards play a fundamental and leading role. In July 2023, the NMPA issued the Measures for the Administration of Standards for Medicinal Products, which for the first time comprehensively and systematically formulated the system and requirements for the administration of drug standards, and will certainly play an important role in standardizing the administration of drug standards.

　　For the development of TCMs in the new era, new ideas and new measures are needed, especially in terms of how to uphold fundamental principles and break new ground and how to promote the high-quality development of the TCM industry. In the process of TCM administration, it is necessary to carry out the requirement of "the most stringent standards" throughout the whole chain of TCM standard administration. At the same time, inheriting the essence, upholding fundamental principles and breaking new ground, and establishing a standard administration system that conforms to the characteristics of TCMs have become important projects in the TCM standard administration. The party group of the NMPA attaches great importance to the administration of TCM standards, and has made a clear request for the "research and formulation of special provisions on the administration of TCM standards" in the Notice by the National Medical Products Administration of Issuing Several Measures on Further Strengthening the Scientific Supervision of Traditional Chinese Medicine to Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine. The formulation and issuance of the Special Provisions on the Administration of Standards for Traditional Chinese Medicines is of great significance in strengthening the administration of TCM standards, establishing and improving a standard system in line with the characteristics of TCMs, and promoting the inheritance, innovation and development of TCMs.

　　II. The relationship between the Special Provisions on the Administration of Standards for Traditional Chinese Medicines and the Measures for the Administration of Standards for Medicinal Products

　　Regarding the administration of TCM standards, the Measures for the Administration of Standards for Medicinal Products and the Special Provisions on the Administration of Standards for Traditional Chinese Medicines are in the relationship of "general" and "special". The Measures for the Administration of Standards for Medicinal Products specify the basic requirements for the administration of drug standards, and make clear provisions for the basic system, working procedures and responsibilities of all parties in the administration of drug standards. The Special Provisions on the Administration of Standards for Traditional Chinese Medicines are based on the characteristics of TCMs, combining the general procedures for the administration of drug standards with the special characteristics of TCMs. Based on the general provisions of the Measures for the Administration of Standards for Medicinal Products, the Special Provisions on the Administration of Standards for Traditional Chinese Medicines further refine and clarify the requirements for the administration of TCM standards in accordance with the classification of TCM product attributes, such as Chinese medicinal materials, prepared slices of Chinese crude drugs, TCM extracts and formula granules, Chinese proprietary medicine, etc., so as to highlight the special characteristics of TCMs.

　　III. How does the Special Provisions on the Administration of Standards for Traditional Chinese Medicines advance the construction of a standard system in line with the characteristics of TCM?

　　The TCMs are drugs used under the guidance of the TCM theory, and the research, formulation and administration of TCM standards must take full account of the characteristics of TCM. During the drafting process of the Special Provisions on the Administration of Standards for Traditional Chinese Medicines, following the TCM theory, respecting the TCM tradition, and embodying the TCM characteristics shall be the fundamental principles that must be adhered to. First, for the emphasis on research and formulation of standards for Chinese medicinal materials, the attention shall be paid to the research and inheritance of traditional quality evaluation methods, and encouragement given to the systematic evaluation and research of the quality characteristics of geo-authentic materia medica. Second, for the emphasis on research and formulation of standards for prepared slices of Chinese crude drugs, the attention shall be paid to the research and inheritance of traditional processing experience, with a focus on the processing process and the determination of the processing endpoint. For the prepared slices of Chinese crude drugs with the characteristics of "toxicity reducing and efficacy enhancing" and "different treatments for raw and cooked herbs", targeted quality control methods shall be established and quality control items shall be set up in a scientific and reasonable manner. Third, for the emphasis on research and formulation of standards for Chinese proprietary medicine, quality control items shall be set up scientifically and reasonably based on the functions and indications, the composition rules of "monarch, minister, assistant and guide", and clinical usage. Fourth, for the emphasis on research and formulation of standards for TCM formula granules, the attention shall be paid to the consistency of basic quality attributes of TCM formula granules and traditional decoctions.

　　IV. Measures taken by the Special Provisions on the Administration of Standards for Traditional Chinese Medicines to optimize the mechanism for forming TCM standards

　　The mechanism for the formation of TCM standards greatly affects the quality and efficiency of the work on TCM standards. In order to further optimize the mechanism for the formation of standards for TCMs, the Special Provisions on the Administration of Standards for Traditional Chinese Medicines actively explore new measures for the regulation of standards for TCMs and introduce new work mechanisms. First, a competition mechanism shall be introduced to implement project management for the formulation and revision of national standards for TCMs. All relevant units can apply publicly and the units responsible for the standard projects will be determined based on merit. Second, comprehensively deepen the disclosure mechanism, emphasize the disclosure of project establishment information, drafting units, sample information, research drafts, and even review experts and review opinions to ensure that standard work follows the principles of publicity, fairness, and justice. Third, further strengthen the incentive mechanism. The Special Provisions on the Administration of Standards for Traditional Chinese Medicines strictly implement the relevant requirements of the Several Measures on Further Strengthening the Scientific Supervision of Traditional Chinese Medicine to Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine, and incorporate the direct application by enterprises and third parties in society to revise national standards for TCMs into the mechanism for forming drug standards. Fourth, a rapid revision mechanism for TCM standards shall be established, requiring the formulation of relevant supporting documents to speed up the revision of TCM standards for related varieties.

　　V. Measures taken by the Special Provisions on the Administration of Standards for Traditional Chinese Medicines to advance the coordinated administration of TCM standards

　　The standards for TCMs involve a large number of departments and the situation is more complex. The Special Provisions on the Administration of Standards for Traditional Chinese Medicines focus on the coordination issues that may be involved in the administration of TCM standards. First, strengthen the coordination of provincial TCM standards, TCM registration standards and national TCM standards, and clarify the circumstances in which national TCM standards need to be formulated and issued. Propose the establishment of a work mechanism for the transformation of TCM registration standards and provincial TCM standards into national standards for TCMs, and strengthen the integration and transformation of various types of standards. Second, the connection issues related to post-market change administration in the revision of national standards for TCMs shall be clarified. For major and moderate changes involved in the national standards for TCMs, the relevant contents of the standards can be revised after approval or filing in accordance with the relevant provisions of post-marketing change management; for minor changes, the relevant contents of the standards can be revised, and the drug manufacturers can submit annual reports in accordance with the relevant requirements of post-marketing change management. Third, further clarify the management mechanism of generic names of TCMs. Clarify the procedure for the revision of the generic name of TCMs for which there are only registration standards, with reference to the procedure relating to the approval of the generic name in the Provisions for Drug Registration, whereby the drug manufacturer shall submit applications in accordance with the requirements for supplementary application, the Center for Drug Evaluation shall notify the Pharmacopoeia Commission for approval of the generic name and provide the relevant information, and the Pharmacopoeia Commission shall provide feedback to the Center for Drug Evaluation after approval.

　　Related Links: Announcement of the National Medical Products Administration on Issuing the Special Provisions on the Administration of Standards for Traditional Chinese Medicines (No. 93, 2024))

　　(Excerpt from: National Medical Products Administration website 2024-07-10)