Health

The National Medical Products Administration has issued the "Special Regulations for the Management of Traditional Chinese Medicine Standards" to establish a standard system that conforms to the characteristics of traditional Chinese medicine

2024-07-16   

Recently, the National Medical Products Administration issued a notice stating that in order to further strengthen the management of traditional Chinese medicine standards, establish a traditional Chinese medicine standard management system that conforms to the characteristics of traditional Chinese medicine, and promote the high-quality development of the traditional Chinese medicine industry, the National Medical Products Administration has organized the formulation of the "Special Regulations on the Management of Traditional Chinese Medicine Standards", which will come into effect on January 1, 2025. The National Medical Products Administration stated in a related interpretation article that the development of traditional Chinese medicine in the new era requires new ideas and measures, especially in terms of how to maintain integrity and innovate, and how to promote the high-quality development of the traditional Chinese medicine industry. In the process of standard management of traditional Chinese medicine, it is necessary to put the requirements of "the most rigorous standard" through the whole chain of standard management of traditional Chinese medicine, while doing a good job in inheriting the essence, maintaining integrity and innovation, and establishing a standard management system consistent with the characteristics of traditional Chinese medicine, which has become an important topic of standard management of traditional Chinese medicine. Therefore, the formulation and release of the "Special Regulations on the Management of Traditional Chinese Medicine Standards" is of great significance for strengthening the management of traditional Chinese medicine standards, establishing and improving a standard system that conforms to the characteristics of traditional Chinese medicine, and promoting the inheritance, innovation, and development of traditional Chinese medicine. Chinese medicine is a medication used under the guidance of traditional Chinese medicine theory, and the research, formulation, and management of Chinese medicine standards must fully consider the characteristics of Chinese medicine itself. In the drafting process of the "Special Regulations on the Standard Management of Traditional Chinese Medicine", following the theory of traditional Chinese medicine, respecting the traditions of traditional Chinese medicine, and reflecting the characteristics of traditional Chinese medicine will be the fundamental principles that must be grasped. One is to emphasize the research and development of standards for traditional Chinese medicinal materials, focusing on the study and inheritance of traditional quality evaluation methods, and encouraging systematic evaluation and research on the quality characteristics of authentic medicinal materials. Secondly, emphasis should be placed on the research and formulation of standards for traditional Chinese medicine decoction pieces. Attention should be paid to the study and inheritance of traditional processing experience, with a focus on the determination of the processing process and endpoint. For Chinese medicine decoction pieces with the characteristics of "reducing toxicity and increasing efficiency" and "treating raw and cooked differently", targeted quality control methods should be established, and quality control projects should be scientifically and reasonably set up. The third is to emphasize the research and formulation of traditional Chinese patent medicines and simple preparations standards, and scientifically and reasonably set up quality control items according to the functional indications, "monarch, minister, assistant" and other prescription rules and clinical use. The fourth is to emphasize the research and development of standards for traditional Chinese medicine formula granules, with a focus on the consistency of the basic quality attributes between traditional Chinese medicine formula granules and traditional decoctions. The mechanism of the formation of traditional Chinese medicine standards largely affects the quality and efficiency of traditional Chinese medicine standard work. In order to further optimize the mechanism for the formation of traditional Chinese medicine standards, the "Special Regulations on the Management of Traditional Chinese Medicine Standards" actively explore new measures for the supervision of traditional Chinese medicine standards and introduce new working mechanisms. One is to introduce a competition mechanism and implement project management for the revision of national standards for traditional Chinese medicine. Relevant units can publicly apply and select the preferred units to undertake standard projects. The second is to comprehensively deepen the disclosure mechanism, emphasizing the disclosure of project proposal information, drafting units, sample information, research drafts, and even review experts and review opinions to ensure the openness, fairness, and impartiality of standard work. The third is to further strengthen the incentive mechanism. The Special Regulations on the Management of Traditional Chinese Medicine Standards strictly implement the relevant requirements of the Measures for Further Strengthening the Scientific Supervision of Traditional Chinese Medicine and Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine, and include the direct application of enterprises and third parties in society to revise the national standards of traditional Chinese medicine in the mechanism for forming drug standards. The fourth is to establish a rapid revision mechanism for traditional Chinese medicine standards, requiring the development of relevant supporting documents and accelerating the revision of traditional Chinese medicine standards for related varieties. (New Society)

Edit:HAN ZHUOLING Responsible editor:CAICAI

Source:People.cn

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