With the implementation of the “Shenzhen Special Economic Zone Series of Standards and Regulations for Traditional Chinese Medicine†(hereinafter referred to as “Standards and Normsâ€) mobilization meeting in July in Shenzhen, Guangdong Province, it was drafted by the Shenzhen Municipal Health and Population Family Planning Commission in 2011. "Standards and Regulations" entered the formal implementation stage.
The “Standards and Regulations†is an important supporting technical standard and specification of the “Shenzhen Special Economic Zone’s Regulations on Traditional Chinese Medicine†and is divided into “Standards for the Establishment of Traditional Chinese Medicine and Integrative Medical Institutions and Implementation Measures for Administrative Licensingâ€, and “Rules and Codes for Traditional Chinese Herbal Medicine and Prescriptionsâ€. The three parts of "Application" and "Technical Specification for Prescription and Adjustment of Chinese Materia Medica" were released in 2010 and 2011 respectively in the "Shenzhen People's Government Gazette".
"Who owns the standards and norms, whoever can become the leader in the industry, can lead the world trend." Wang Guoqiang, vice minister of the Ministry of Health and director of the State Administration of Traditional Chinese Medicine pointed out: "Shenzhen is the first in the country to publish series of standards and specifications for Chinese medicine. The local standards will further promote the standardization, standardization and informationization of the Chinese medicine service system, effectively improve the service capacity and level of Chinese medicine, promote the trade in Chinese medicine and enter the international market, and deepen the reform of the pharmaceutical and health system for the country. The inheritance, innovation and development provided a vivid experience."
Shenzhen’s development of Chinese medicine has attracted much attention since it was proposed in 2006 by Shenzhen City to be the vanguard of a strong province of Chinese medicine.
Background and Significance: From "Shenzhen speed" to "Shenzhen quality" jumped "Shenzhen Special Economic Zone Regulations on Traditional Chinese Medicine" July 1, 2010 formally implemented to protect the development of traditional Chinese medicine according to law, and effectively promote the process of standardization and standardization of traditional Chinese medicine. In 2011, the Shenzhen Municipal Committee and the municipal government proposed "innovative development, Shenzhen quality, and refined management." The TCM departments of Chinese TCM hospitals and general hospitals provide more than 10 million Chinese medicine clinics per year, and more than 6,000 retail pharmacies meet the demand for more than 10 million Chinese medicine services. "To comprehensively upgrade the service quality of the Chinese medicine industry will be even more arduous and urgent," said Wu Yihuan, deputy mayor of Shenzhen.
The director of the Department of Traditional Chinese Medicine of the Shenzhen Municipal Health and Population Family Planning Commission, Liao Liping, said: “Now, people’s increasing demand for traditional Chinese medicine (TCM) has increased their attention to medical quality and medication safety; while medical practices and drug distribution management of Chinese medicine still do not exist. Less problems need to be standardized; in addition, the development of Chinese medicine is highly valued from the central government, the province to the city, and Shenzhen Chinese medicine practitioners should dare to play the role.â€
Regarding the significance of the implementation of the “Standards and Normsâ€, Liao Liping further elaborated: First, it is an important basis for managing and improving the quality of Chinese medicine services. Strict implementation of the Chinese pharmaceutical standards, the Chinese traditional Chinese medicine processing and processing techniques, and put forward the basis for standardizing the quality standards of Chinese medicine. While improving management efficiency, the quality of Chinese medicine services and the safety of medications will be improved.
The second is to effectively promote the independent innovation of Chinese medicine. Started the construction of “Digital Medicine†project, using information technology tools and coding technology rules to apply TCM syndrome differentiation, rational prescriptions, clinical addition and subtraction, Chinese herbal medicine preparation, medical technology level, medical quality and sources of traditional Chinese medicine, medicinal site efficacy, and processing Processing methods, specifications, and other information are collected in digital maps to build a standardized and standardized Chinese medicine system with independent intellectual property rights.
The third is to help strengthen and expand the traditional Chinese medicine manufacturing industry. In response to the problem of “poor use of medicinal herbs in the market†and “the lack of scientific guidance in the production of authentic medicinal materials†and the inconsistency in the specifications, methods of frying and the technical requirements of Chinese herbal medicines, Chinese medicine standards and specifications conforming to the characteristics of Chinese medicine have been established to realize Chinese medicine. Interconnecting and coordinating services with the departments of drug supervision and management, human resources and social security, science, industry and trade, market supervision, and intellectual property rights, and jointly building a platform for promoting the development of Chinese medicine.
The fourth is to become an important way to promote Chinese medicine to the world. The "Standards and Regulations" is based on the principles of "safety and effectiveness in drug use" and "independent innovation" to overcome the deficiencies of different regions, dialects, and differences in international languages, and to promote the internationalization of Chinese medicine, seize the high ground, and expand the market. Share, successfully explored and possessed the only national ID code.
Content and Characteristics: There are two general ideas for preparation of TCM decoction pieces with the unique ID code “Standards and Codesâ€. One is the “bottom line†for ensuring the safety and effectiveness of people's drug use. Taking standardization and standardization as the starting point, we must earnestly abide by professional ethics and strictly implement drug standards. We should clean up the original source, pass on Chinese traditional medicine processing techniques and techniques, give full play to the characteristics and advantages of traditional Chinese medicine, ensure the safety and effectiveness of people's livelihood medicine, and allow ordinary people to feel comfortable with medicine.
The other is the independent development of Chinese medicine development model, out of the "country." Taking digitalization and information as a platform, taking the traditional Chinese medicine code and the prescription of Chinese medicine prescriptions as the starting point, we will expand the international market of Chinese medicine and allow Chinese medicine to go global. The organic combination of the two is the integration of the inheritance and development, innovation and development of Chinese medicine.
Wang Guoqiang spoke highly of the contents and characteristics of the "Standards and Regulations." "At present, any commodity in China has a barcode, and medicines are special commodities. No exception is possible. Western medicine and proprietary Chinese medicines all have bar code labels, but Chinese herbal medicines are not available. It is not consistent with the practice of commodity circulation. "Shenzhen City has studied the coding system of Chinese Herbal Medicine Pieces and Chinese Herbal Formulas, determined its coding rules and promoted its use. It has filled a gap in the country and is a remarkable achievement. This will be the path and entry point for promoting the informationization of traditional Chinese medicine, and it will also change the situation of the informatization of traditional Chinese medicine."
The "Standards and Regulations" are the industry standards for Shenzhen medical units, health administration, Chinese medicine management, health supervision, pharmaceutical distribution, and market management, including three major parts (three volumes):
The "Standards for the Establishment of Traditional Chinese Medicine and Western Medicine Medical Institutions and the Implementation Measures for Administrative Licensing" put forward specific regulations for the admission standards of "Chinese Medicine Hall", "Chinese Medicine Hospital Sitting Clinic Medical Clinic", and "Chinese Medicine and TCM Western Medicine Medical Institution". Its characteristics are to expand and improve the service capabilities and coverage of the Chinese medicine industry. The Chinese Medicine Clinic Clinic took the lead in “breaking the ice†and proceeding from trials to access to the legal level; the setting of the “Chinese Medicine Hall†and “Chinese Medicine Clinic†has added a new class of access standards for medical institutions across the country.
The “Rules and Codes for Chinese Medicinal Pieces and Prescriptions and Their Applications†includes standardized technical guidelines such as traditional Chinese medicine decoction pieces, Chinese herbal prescription codes, and codes and representations in supply chain management. The Chinese medicine source, medicinal site, efficacy, processing methods, specifications and requirements, etc., to form the coding rules of Chinese Herbal Medicine Pieces and Chinese Herbal Formulas, and the use of simple and concise digital coded logos for the expression of tedious and messy Chinese medicines, making 1298 Chinese Herbal Medicine Pieces and 703 Prescription agent has a fixed, unique "ID card" code.
The “Technical Code for Prescription and Adjustment of Chinese Materia Medica†includes standard prescriptions for traditional Chinese medicines and traditional Chinese medicine preparations, and procurement of traditional Chinese medicines, conservation of traditional Chinese medicines, prescriptions for traditional Chinese medicines, and deconstruction of traditional Chinese medicine decoctions, etc. The “eight specifications†of prescriptions and preparations for Chinese medicines are proposed.
Implementation and forward-looking: step by step, step by step, and create experience To promote the smooth implementation of the “Standards and Normsâ€, Shenzhen Municipal Health Population Planning Commission, Market Supervision Authority and Drug Administration Bureau jointly sponsored the implementation of the “Standards and Norms†by the whole city. Mobilization meeting.
Xu Sihu, deputy director of the Shenzhen Municipal Population and Family Planning Commission, stated that as the leading unit in implementing the “Standards and Regulationsâ€, the Municipal Health Population and Family Planning Commission and the Market Supervision Authority, Drug Administration Bureau, Health Supervision Bureau, Standard Technology Research Institute, and Drug Inspection Institutes, medical information centers, and other member units gave full play to the effectiveness of their cooperation, implemented various measures, regularly inspected the implementation of the "Standards and Regulations," and used the criteria as the basis of technology to improve the management system and traceability system of Chinese medicine products to ensure the safety of people's medication.
It is understood that Shenzhen will conduct trials at the Municipal Chinese Hospital, the Municipal People's Hospital, the Luohu District Chinese Medicine Hospital, Bao'an District Traditional Chinese Medicine, and Youhe Pharmaceutical Co., etc., actively explore ways to operate in practice, identify and solve problems in a timely manner, and gradually establish Chinese Herbal Pieces. The access and withdrawal mechanism for coding has gradually progressed from point to point. When the conditions are ripe, it will be extended to various medical institutions and production and management companies in the city, so as to build and ensure that the Chinese medicine decoction pieces enter the prevention and control information system for safe use.
"In an appropriate time, the "Code Regulations" have been upgraded to national standards to facilitate the cross-regional operations of enterprises." Song Gang, Chairman of Shenzhen Heshuntang Pharmaceutical Co., Ltd. believes that companies can use off-the-shelf standardized coding results to reduce self-encoding The workload, reduce operating costs and ensure the quality of the code. If this normative code is implemented in regions and countries, data collection and analysis can be performed quickly and without the need for complicated code conversion work, and the monitoring and management of the Chinese medicine market can be strengthened.
Zhan Wenlu, general manager of Shenzhen Youhe Pharmaceutical Co., Ltd., hopes to use standards and regulations to enhance the access of Chinese herbal medicines. As the pilot unit of the first batch of operating companies of the “Standards and Regulationsâ€, Youhe Pharmaceutical requested that the suppliers of TCM decoction pieces be required to provide TCM Decoction Piece barcodes for the tracking of the source of each type of TCM decoction pieces at the same time that each TCM product is required to comply with the TCM Decoction Piece Supply Chain Management. And to strengthen the "standards and norms" of the study, in the purchase of Chinese medicine, conservation, adjustment and payment and the decoction of traditional Chinese medicine for staff training.
Li Shunmin, head of the Shenzhen Chinese Medicine Hospital, said that the hospital incorporated the core indicators of standardization and standardization in the management of annual activities and connotation of traditional Chinese medicine hospitals. It was the key target in the hospital's long-term development plan and rolled out the Chinese medicine series across the board. Standardization and standardization work.
The “Standards and Regulations†is an important supporting technical standard and specification of the “Shenzhen Special Economic Zone’s Regulations on Traditional Chinese Medicine†and is divided into “Standards for the Establishment of Traditional Chinese Medicine and Integrative Medical Institutions and Implementation Measures for Administrative Licensingâ€, and “Rules and Codes for Traditional Chinese Herbal Medicine and Prescriptionsâ€. The three parts of "Application" and "Technical Specification for Prescription and Adjustment of Chinese Materia Medica" were released in 2010 and 2011 respectively in the "Shenzhen People's Government Gazette".
"Who owns the standards and norms, whoever can become the leader in the industry, can lead the world trend." Wang Guoqiang, vice minister of the Ministry of Health and director of the State Administration of Traditional Chinese Medicine pointed out: "Shenzhen is the first in the country to publish series of standards and specifications for Chinese medicine. The local standards will further promote the standardization, standardization and informationization of the Chinese medicine service system, effectively improve the service capacity and level of Chinese medicine, promote the trade in Chinese medicine and enter the international market, and deepen the reform of the pharmaceutical and health system for the country. The inheritance, innovation and development provided a vivid experience."
Shenzhen’s development of Chinese medicine has attracted much attention since it was proposed in 2006 by Shenzhen City to be the vanguard of a strong province of Chinese medicine.
Background and Significance: From "Shenzhen speed" to "Shenzhen quality" jumped "Shenzhen Special Economic Zone Regulations on Traditional Chinese Medicine" July 1, 2010 formally implemented to protect the development of traditional Chinese medicine according to law, and effectively promote the process of standardization and standardization of traditional Chinese medicine. In 2011, the Shenzhen Municipal Committee and the municipal government proposed "innovative development, Shenzhen quality, and refined management." The TCM departments of Chinese TCM hospitals and general hospitals provide more than 10 million Chinese medicine clinics per year, and more than 6,000 retail pharmacies meet the demand for more than 10 million Chinese medicine services. "To comprehensively upgrade the service quality of the Chinese medicine industry will be even more arduous and urgent," said Wu Yihuan, deputy mayor of Shenzhen.
The director of the Department of Traditional Chinese Medicine of the Shenzhen Municipal Health and Population Family Planning Commission, Liao Liping, said: “Now, people’s increasing demand for traditional Chinese medicine (TCM) has increased their attention to medical quality and medication safety; while medical practices and drug distribution management of Chinese medicine still do not exist. Less problems need to be standardized; in addition, the development of Chinese medicine is highly valued from the central government, the province to the city, and Shenzhen Chinese medicine practitioners should dare to play the role.â€
Regarding the significance of the implementation of the “Standards and Normsâ€, Liao Liping further elaborated: First, it is an important basis for managing and improving the quality of Chinese medicine services. Strict implementation of the Chinese pharmaceutical standards, the Chinese traditional Chinese medicine processing and processing techniques, and put forward the basis for standardizing the quality standards of Chinese medicine. While improving management efficiency, the quality of Chinese medicine services and the safety of medications will be improved.
The second is to effectively promote the independent innovation of Chinese medicine. Started the construction of “Digital Medicine†project, using information technology tools and coding technology rules to apply TCM syndrome differentiation, rational prescriptions, clinical addition and subtraction, Chinese herbal medicine preparation, medical technology level, medical quality and sources of traditional Chinese medicine, medicinal site efficacy, and processing Processing methods, specifications, and other information are collected in digital maps to build a standardized and standardized Chinese medicine system with independent intellectual property rights.
The third is to help strengthen and expand the traditional Chinese medicine manufacturing industry. In response to the problem of “poor use of medicinal herbs in the market†and “the lack of scientific guidance in the production of authentic medicinal materials†and the inconsistency in the specifications, methods of frying and the technical requirements of Chinese herbal medicines, Chinese medicine standards and specifications conforming to the characteristics of Chinese medicine have been established to realize Chinese medicine. Interconnecting and coordinating services with the departments of drug supervision and management, human resources and social security, science, industry and trade, market supervision, and intellectual property rights, and jointly building a platform for promoting the development of Chinese medicine.
The fourth is to become an important way to promote Chinese medicine to the world. The "Standards and Regulations" is based on the principles of "safety and effectiveness in drug use" and "independent innovation" to overcome the deficiencies of different regions, dialects, and differences in international languages, and to promote the internationalization of Chinese medicine, seize the high ground, and expand the market. Share, successfully explored and possessed the only national ID code.
Content and Characteristics: There are two general ideas for preparation of TCM decoction pieces with the unique ID code “Standards and Codesâ€. One is the “bottom line†for ensuring the safety and effectiveness of people's drug use. Taking standardization and standardization as the starting point, we must earnestly abide by professional ethics and strictly implement drug standards. We should clean up the original source, pass on Chinese traditional medicine processing techniques and techniques, give full play to the characteristics and advantages of traditional Chinese medicine, ensure the safety and effectiveness of people's livelihood medicine, and allow ordinary people to feel comfortable with medicine.
The other is the independent development of Chinese medicine development model, out of the "country." Taking digitalization and information as a platform, taking the traditional Chinese medicine code and the prescription of Chinese medicine prescriptions as the starting point, we will expand the international market of Chinese medicine and allow Chinese medicine to go global. The organic combination of the two is the integration of the inheritance and development, innovation and development of Chinese medicine.
Wang Guoqiang spoke highly of the contents and characteristics of the "Standards and Regulations." "At present, any commodity in China has a barcode, and medicines are special commodities. No exception is possible. Western medicine and proprietary Chinese medicines all have bar code labels, but Chinese herbal medicines are not available. It is not consistent with the practice of commodity circulation. "Shenzhen City has studied the coding system of Chinese Herbal Medicine Pieces and Chinese Herbal Formulas, determined its coding rules and promoted its use. It has filled a gap in the country and is a remarkable achievement. This will be the path and entry point for promoting the informationization of traditional Chinese medicine, and it will also change the situation of the informatization of traditional Chinese medicine."
The "Standards and Regulations" are the industry standards for Shenzhen medical units, health administration, Chinese medicine management, health supervision, pharmaceutical distribution, and market management, including three major parts (three volumes):
The "Standards for the Establishment of Traditional Chinese Medicine and Western Medicine Medical Institutions and the Implementation Measures for Administrative Licensing" put forward specific regulations for the admission standards of "Chinese Medicine Hall", "Chinese Medicine Hospital Sitting Clinic Medical Clinic", and "Chinese Medicine and TCM Western Medicine Medical Institution". Its characteristics are to expand and improve the service capabilities and coverage of the Chinese medicine industry. The Chinese Medicine Clinic Clinic took the lead in “breaking the ice†and proceeding from trials to access to the legal level; the setting of the “Chinese Medicine Hall†and “Chinese Medicine Clinic†has added a new class of access standards for medical institutions across the country.
The “Rules and Codes for Chinese Medicinal Pieces and Prescriptions and Their Applications†includes standardized technical guidelines such as traditional Chinese medicine decoction pieces, Chinese herbal prescription codes, and codes and representations in supply chain management. The Chinese medicine source, medicinal site, efficacy, processing methods, specifications and requirements, etc., to form the coding rules of Chinese Herbal Medicine Pieces and Chinese Herbal Formulas, and the use of simple and concise digital coded logos for the expression of tedious and messy Chinese medicines, making 1298 Chinese Herbal Medicine Pieces and 703 Prescription agent has a fixed, unique "ID card" code.
The “Technical Code for Prescription and Adjustment of Chinese Materia Medica†includes standard prescriptions for traditional Chinese medicines and traditional Chinese medicine preparations, and procurement of traditional Chinese medicines, conservation of traditional Chinese medicines, prescriptions for traditional Chinese medicines, and deconstruction of traditional Chinese medicine decoctions, etc. The “eight specifications†of prescriptions and preparations for Chinese medicines are proposed.
Implementation and forward-looking: step by step, step by step, and create experience To promote the smooth implementation of the “Standards and Normsâ€, Shenzhen Municipal Health Population Planning Commission, Market Supervision Authority and Drug Administration Bureau jointly sponsored the implementation of the “Standards and Norms†by the whole city. Mobilization meeting.
Xu Sihu, deputy director of the Shenzhen Municipal Population and Family Planning Commission, stated that as the leading unit in implementing the “Standards and Regulationsâ€, the Municipal Health Population and Family Planning Commission and the Market Supervision Authority, Drug Administration Bureau, Health Supervision Bureau, Standard Technology Research Institute, and Drug Inspection Institutes, medical information centers, and other member units gave full play to the effectiveness of their cooperation, implemented various measures, regularly inspected the implementation of the "Standards and Regulations," and used the criteria as the basis of technology to improve the management system and traceability system of Chinese medicine products to ensure the safety of people's medication.
It is understood that Shenzhen will conduct trials at the Municipal Chinese Hospital, the Municipal People's Hospital, the Luohu District Chinese Medicine Hospital, Bao'an District Traditional Chinese Medicine, and Youhe Pharmaceutical Co., etc., actively explore ways to operate in practice, identify and solve problems in a timely manner, and gradually establish Chinese Herbal Pieces. The access and withdrawal mechanism for coding has gradually progressed from point to point. When the conditions are ripe, it will be extended to various medical institutions and production and management companies in the city, so as to build and ensure that the Chinese medicine decoction pieces enter the prevention and control information system for safe use.
"In an appropriate time, the "Code Regulations" have been upgraded to national standards to facilitate the cross-regional operations of enterprises." Song Gang, Chairman of Shenzhen Heshuntang Pharmaceutical Co., Ltd. believes that companies can use off-the-shelf standardized coding results to reduce self-encoding The workload, reduce operating costs and ensure the quality of the code. If this normative code is implemented in regions and countries, data collection and analysis can be performed quickly and without the need for complicated code conversion work, and the monitoring and management of the Chinese medicine market can be strengthened.
Zhan Wenlu, general manager of Shenzhen Youhe Pharmaceutical Co., Ltd., hopes to use standards and regulations to enhance the access of Chinese herbal medicines. As the pilot unit of the first batch of operating companies of the “Standards and Regulationsâ€, Youhe Pharmaceutical requested that the suppliers of TCM decoction pieces be required to provide TCM Decoction Piece barcodes for the tracking of the source of each type of TCM decoction pieces at the same time that each TCM product is required to comply with the TCM Decoction Piece Supply Chain Management. And to strengthen the "standards and norms" of the study, in the purchase of Chinese medicine, conservation, adjustment and payment and the decoction of traditional Chinese medicine for staff training.
Li Shunmin, head of the Shenzhen Chinese Medicine Hospital, said that the hospital incorporated the core indicators of standardization and standardization in the management of annual activities and connotation of traditional Chinese medicine hospitals. It was the key target in the hospital's long-term development plan and rolled out the Chinese medicine series across the board. Standardization and standardization work.
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