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Grasping the leading power of the formulation of international standards for Chinese medicine

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[Pulse]

Not long ago, the State Council issued the "13th Five-Year National Drug Safety Plan", which proposed to amend 1,100 national Chinese medicine national medicine standards, so that the Chinese medicine (material) standards are in an international dominant position. The author believes that the proposal of "the standard of Chinese medicine (material) is in an international dominant position" fully shows that China has begun to grasp the leading power of the formulation of international standards for Chinese medicine from the national level.

 

Since the reform and opening up, China has carried out a series of research and formulation of Chinese medicine standards and norms, and has promulgated more than 120 standards and norms of Chinese medicine. The promulgation and implementation of these standards and norms have played a positive role in promoting the development of Chinese medicine, and laid a good foundation for the standardization of Chinese medicine. But at the same time, the standardization of Chinese medicine still faces many problems. For example, the standardization awareness in the industry is not strong; the standardization of Chinese medicine is still in the process of exploration, the standard adaptability is not strong, and it cannot meet the needs of medical, scientific research, educational development and foreign exchange and cooperation; the promotion and operation mechanism is not perfect, and there is no overall planning and effective Organization and funding guarantees, lack of standardized professionals.

 

At present, traditional Chinese medicine can only be used as a health food or food additive in most countries, and there is no legal drug status. To this end, industry players have been calling for a "right name" for Chinese medicine. China's traditional Chinese medicine industry now has two paths, namely, research and development according to the traditional Chinese medicine theory and modeling on chemical drugs or biopharmaceuticals. Therefore, in the process of formulating international standards for Chinese medicine, they should be combined with each other and complement each other. According to the characteristics of different Chinese medicines, the modernization model of traditional Chinese medicine such as chemical model and plant model should be absorbed.

 

China has independent standards in all aspects of research, development, production, management, use and management of traditional Chinese medicine. They have penetrated the whole process of Chinese medicine pharmaceuticals, and it is necessary to further improve this system. It is also known that China now has 27 national standards for Chinese medicine and 209 industry standards, and there are also some different norms in different regions. In this regard, many people in the industry suggest that these standards and norms should be unified into national standards and norms, and then gradually improve and improve, leading the establishment of product standards, and promote the standard in line with the international, rather than blindly adapt to Western standards.

 

In order for our Chinese medicine standards to lead the development of international standards, it is necessary to form and establish internationally recognized quality control concepts, scientific research methods and practical testing methods that can effectively protect the efficacy and safety of Chinese medicines (including ethnic medicines and natural medicines). It is also necessary to speed up the development of China's pharmaceutical physical standards and ensure that physical standards and text standards can be developed and implemented simultaneously. Therefore, it is necessary to quickly establish an international database of drug-standard substances such as traditional Chinese medicines with unique international influence.

 

In terms of Chinese medicine standards, it is necessary to focus on improving the quality of Chinese herbal medicines, protecting wild medicinal materials, traditional Chinese medicine and intellectual property rights, focusing on germplasm resources of Chinese medicinal materials, medicinal plant and animal roots, seed saplings, authentic medicinal materials, and Chinese medicine processing. Research and revision of standards for the protection of Chinese medicine resources and quality control of Chinese herbal medicines to address the most urgent technical standards in the field of Chinese herbal medicine quality and resource protection. Focusing on the clinical use of traditional Chinese medicine, we will focus on the formulation and revision of prescription standards, Chinese medicine names, decoction methods, and storage management to ensure the safety and efficacy of clinical drugs.

 

In the process of formulating international standards for Chinese medicine, it is necessary to give full play to the responsibilities and roles of the government, industry associations, enterprises and relevant standardization technical committees in the construction of the international standardization system. Chinese medicine enterprises and research institutions should actively participate in and encourage them to join forces. On the basis of existing standards, they have developed a number of technical standards with independent intellectual property rights, promoted the certification of Chinese medicine international standards, and promoted Chinese medicine to go abroad. At the same time, we must strengthen implementation and focus on effectiveness. Through perfecting the management and operation mechanism, establishing and improving the standard implementation supervision and information feedback mechanism, improving the applicability and effectiveness of the standard, and forming a benign closed-loop operation system for standard formulation, standard implementation, and standard revision.[Pulse]

 

Not long ago, the State Council issued the "13th Five-Year National Drug Safety Plan", which proposed to amend 1,100 national Chinese medicine national medicine standards, so that the Chinese medicine (material) standards are in an international dominant position. The author believes that the proposal of "the standard of Chinese medicine (material) is in an international dominant position" fully shows that China has begun to grasp the leading power of the formulation of international standards for Chinese medicine from the national level.

 

Since the reform and opening up, China has carried out a series of research and formulation of Chinese medicine standards and norms, and has promulgated more than 120 standards and norms of Chinese medicine. The promulgation and implementation of these standards and norms have played a positive role in promoting the development of Chinese medicine, and laid a good foundation for the standardization of Chinese medicine. But at the same time, the standardization of Chinese medicine still faces many problems. For example, the standardization awareness in the industry is not strong; the standardization of Chinese medicine is still in the process of exploration, the standard adaptability is not strong, and it cannot meet the needs of medical, scientific research, educational development and foreign exchange and cooperation; the promotion and operation mechanism is not perfect, and there is no overall planning and effective Organization and funding guarantees, lack of standardized professionals.

 

At present, traditional Chinese medicine can only be used as a health food or food additive in most countries, and there is no legal drug status. To this end, industry players have been calling for a "right name" for Chinese medicine. China's traditional Chinese medicine industry now has two paths, namely, research and development according to the traditional Chinese medicine theory and modeling on chemical drugs or biopharmaceuticals. Therefore, in the process of formulating international standards for Chinese medicine, they should be combined with each other and complement each other. According to the characteristics of different Chinese medicines, the modernization model of traditional Chinese medicine such as chemical model and plant model should be absorbed.

 

China has independent standards in all aspects of research, development, production, management, use and management of traditional Chinese medicine. They have penetrated the whole process of Chinese medicine pharmaceuticals, and it is necessary to further improve this system. It is also known that China now has 27 national standards for Chinese medicine and 209 industry standards, and there are also some different norms in different regions. In this regard, many people in the industry suggest that these standards and norms should be unified into national standards and norms, and then gradually improve and improve, leading the establishment of product standards, and promote the standard in line with the international, rather than blindly adapt to Western standards.

 

In order for our Chinese medicine standards to lead the development of international standards, it is necessary to form and establish internationally recognized quality control concepts, scientific research methods and practical testing methods that can effectively protect the efficacy and safety of Chinese medicines (including ethnic medicines and natural medicines). It is also necessary to speed up the development of China's pharmaceutical physical standards and ensure that physical standards and text standards can be developed and implemented simultaneously. Therefore, it is necessary to quickly establish an international database of drug-standard substances such as traditional Chinese medicines with unique international influence.

 

In terms of Chinese medicine standards, it is necessary to focus on improving the quality of Chinese herbal medicines, protecting wild medicinal materials, traditional Chinese medicine and intellectual property rights, focusing on germplasm resources of Chinese medicinal materials, medicinal plant and animal roots, seed saplings, authentic medicinal materials, and Chinese medicine processing. Research and revision of standards for the protection of Chinese medicine resources and quality control of Chinese herbal medicines to address the most urgent technical standards in the field of Chinese herbal medicine quality and resource protection. Focusing on the clinical use of traditional Chinese medicine, we will focus on the formulation and revision of prescription standards, Chinese medicine names, decoction methods, and storage management to ensure the safety and efficacy of clinical drugs.

 

In the process of formulating international standards for Chinese medicine, it is necessary to give full play to the responsibilities and roles of the government, industry associations, enterprises and relevant standardization technical committees in the construction of the international standardization system. Chinese medicine enterprises and research institutions should actively participate in and encourage them to join forces. On the basis of existing standards, they have developed a number of technical standards with independent intellectual property rights, promoted the certification of Chinese medicine international standards, and promoted Chinese medicine to go abroad. At the same time, we must strengthen implementation and focus on effectiveness. Through perfecting the management and operation mechanism, establishing and improving the standard implementation supervision and information feedback mechanism, improving the applicability and effectiveness of the standard, and forming a benign closed-loop operation system for standard formulation, standard implementation, and standard revision.