The State Drug Administration issued a document on the weight of Chinese medicine to promote the innovation and development of Chinese medicine heritage

Medicine Network December 28 - The State Drug Administration issued a heavy document to promote the inheritance and innovation of Traditional Chinese medicine - plans to reform the classification of Chinese medicine registration according to the characteristics of Chinese medicine registered products, and no longer only use the material basis as the basis for the classification of registration categories.
1, the State Drug Administration issued a document to promote the innovation and development of Traditional Chinese medicine on the evening of December 25, the State Drug Administration issued "on the promotion of the chinese medicine heritage and innovation and development of the implementation of the Opinions" (hereinafter referred to as opinions).
The State Drug Administration said that Chinese medicine is a treasure of the Chinese nation and has made great contributions to the health of the people, especially since the outbreak of the new crown pneumonia, chinese medicine has demonstrated its unique advantages and played an important role in winning the battle against the epidemic.
The CPC Central Committee and the State Council attach great importance to the work of Chinese medicine, especially since the 18th National Congress of the CPC, the country's top leaders have repeatedly issued important instructions and instructions calling for reform and improvement of the review and approval mechanism for Chinese medicine, which has pointed out the direction and provided a follow-up for the innovation and development of Chinese medicine heritage in the new era.
the State Drug Administration, in order to further implement the decision-making and deployment of the Cpc Central Committee and the State Council's Opinions on Promoting the Innovation and Development of Traditional Chinese Medicine, combined with the actual work of drug supervision, put forward the following opinions.
to promote the innovation of Chinese medicine and adhere to the clinical value-oriented.
importance to the clinical evaluation of clinical value according to the characteristics and actual treatment characteristics of Chinese medicine, pay attention to meeting the unseeded clinical needs, and formulate technical guidelines for the evaluation of the clinical value of new Chinese medicine.
establish the evaluation criteria of efficacy which is suitable for the clinical orientation of Chinese medicine and reflects its function characteristics and advantages.
encourage patient-centered efficacy evaluations.
to explore the introduction of real-world evidence to support the registration and listing of new Chinese medicines.
to promote the development of ancient classical prescription Chinese medicine compound preparation.
to clarify the technical requirements for the development of ancient classic prescription Chinese medicine compound preparations, promote the research and development of ancient classic prescription Chinese medicine compound preparations, and promote the transformation of ancient classic prescriptions in the direction of new drugs.
the State Council, establish a communication and coordination mechanism to organize research and formulate key information examination opinions on ancient classics.
establish a review model that is suitable for the characteristics of the ancient classical prescription Chinese medicine compound preparation, set up an expert review committee for the ancient classic prescription Chinese medicine compound preparation, and implement simplified approval.
promote the innovation and development of Chinese medicine.
new tools, new methods, new technologies and new standards for the evaluation of the efficacy of traditional Chinese medicine.
to promote the development of multi-regional clinical trial normative research capacity and system construction, and promote the overall improvement of the quality of clinical research in Chinese medicine.
to give full play to the role of "incubator" for the inheritance and innovation of Chinese medicine preparations in medical institutions, and encourage medical institutions to convert preparations into new Chinese medicines.
to support the development of new Chinese medicine in various ways, such as combination of medical certificates, specialized medical drugs or certificate-waiting Chinese medicine.
encourage secondary development.
to formulate relevant technical requirements for the research of new drugs of Chinese medicine improvement, and to support the use of new technologies, new processes and new dosage forms that reflect the advantages and characteristics of clinical application.
support the development of the same prescription drug of the same name and promote the quality competition between the listed Chinese medicine and the variety.
to optimize the relevant technical requirements for chinese medicine changes that are already on the market.
to strengthen the safety of Chinese medicine research.
to guide drug market licensing holders to take the initiative to carry out post-market research and post-market evaluation of Chinese medicine.
establish a safety evaluation method and standard system that conforms to the characteristics of Traditional Chinese medicine, and establish a classification and evaluation strategy of Chinese medicine safety based on the clinical orientation of Chinese medicine.
to increase the research on the technical standards for evaluating the safety evaluation of new Chinese medicines with human experience, such as ancient classics, old Chinese medicine, medical institutions, etc.
according to the drug group, human experience, preparation process, usage, functional treatment characteristics, etc., during clinical trials or after the market, to carry out the corresponding non-clinical and clinical safety studies at all stages.
reform of the registration classification of Chinese medicine by improving the review and approval system in line with the characteristics of Chinese medicine.
respect the characteristics of Traditional Chinese medicine, follow the law of chinese medicine development, and combine the basic requirements of "safe, effective and controllable quality" medicine with the unique theoretical system and practical characteristics of the innovation and development of Traditional Chinese medicine.
According to the characteristics, innovation degree and development practice of Chinese medicine registered products, reform the classification of Chinese medicine registration, no longer only on the material basis as the basis for dividing the registration category, open up a registration declaration path with Chinese medicine characteristics.
to construct a "three-combination" review evidence system.
we should pay more attention to the support role of human experience in the safety and effectiveness of Chinese medicine, and construct a review evidence system combining Chinese medicine theory, human experience and clinical trials according to the characteristics, research and development laws and practice of Chinese medicine.
strengthen the standard collection and collation of human experience, and standardize the requirements for reporting information.
reform and improve the system of review and approval of Chinese medicine.
the application for new Chinese medicines with clear clinical orientation and obvious clinical value for major diseases, prevention and treatment of rare diseases, clinical urgent needs and market shortages, or for new Chinese medicines that belong to children's medicines shall be reviewed and approved on a priority level.
If the treatment of a serious life-threatening disease and there is no effective treatment means, as well as the competent department of health and health or Chinese medicine under the State Council, is determined to be an urgent need for Chinese medicine, the clinical trial of the drug has data or high-quality Chinese medicine human experience evidence shows efficacy and can predict its clinical value, it may be approved with conditions.
to implement special approval for the increased functional treatment of listed Chinese medicines required for emergencies in major public health emergencies.
strengthen the quality and safety supervision of Chinese medicine to strengthen the quality source management of Chinese medicine.
Revise the Quality Management Code (GAP) for the production of Chinese herbal medicines, formulate guidelines for the implementation of the quality management norms for the production of Chinese herbal medicines, guide the promotion of standardized cultivation and cultivation of Chinese herbal medicines, promote the processing of the origin of Chinese herbal medicines, encourage Chinese medicine beverage tablet enterprises to extend the quality assurance system to the planting and processing links, and strengthen the quality control of Chinese herbal medicine and Chinese herbal medicine tablets from the source.
strengthen and standardize the quality management of Chinese medicine and Chinese medicine tablets for new medicine, and clarify the technical requirements for quality control research.
to protect wild medicinal resources and strictly restrict the use of endangered wild animal and plant medicinal herbs.
to strengthen the assessment of resources for new Chinese medicine and ensure the stability of the sources of Chinese herbal medicines and the sustainable use of resources.
quality control of the whole production process.
to step up flight inspection efforts, strict implementation of drug production quality management norms (GMP).
, on the basis of inheriting the traditional methods and experiences of Chinese medicine tablets, revise the appendix of Chinese medicine tablets to the quality management standards of pharmaceutical production.
to continuously revise and improve the complete system of internal control quality standards, including Chinese herbal medicines, Chinese medicine tablets, intermediate products and preparations, etc., to maintain stable and controllable quality between batches of medicines.
promote the upgrading of Chinese medicine and pharmaceutical technology, and encourage production enterprises to gradually achieve intelligent manufacturing.
strengthen post-listing regulation.
organization of special inspection of Chinese medicine, continue to increase the sampling of Chinese medicine and Chinese medicine tablets, continue to investigate and resolve hidden risks, according to law to deal with illegal and illegal enterprises.
focus on doping to make false, dyeing weight gain, illegal addition, illegal channels to buy Chinese medicine tablets and other issues, to carry out the quality of Chinese medicine drink tablets centralized rectification, and crack down on illegal violations.
local governments to implement local regulatory responsibilities, strengthen supervision of the Chinese medicine trading market, crack down on undocumented sales of Chinese medicine tablets, and continuously purify the market order.
based on the actual development of Chinese medicine, research and improve the circulation policy for the production of Chinese medicine tablets in accordance with the provincial drinking tablets.
strengthen the monitoring of adverse reactions of Chinese medicine, and timely organize and evaluate the risk signals found in the monitoring and take risk control measures.
strengthen the management of Chinese medicine instructions and labels, and promote the revision and improvement of relevant contents such as taboos, adverse reactions and precautions in the listed Chinese medicine instructions.
to strengthen the protection of Chinese medicine species.
Amend the Regulations on the Protection of Chinese Medicine Species, integrate the protection system of Chinese medicine species with the patent protection system, and incorporate it into the whole life cycle registration management of Chinese medicine, and give full play to its protective role in the protection of Chinese medicine varieties such as innovative Chinese medicine, chinese medicine improved new medicine and ancient classic Chinese medicine compound preparations.
support the registration and declaration of relevant patent information by the license holder or applicant for the listing of the drug in accordance with the relevant provisions.
2, to promote the revitalization and development of Chinese medicine, multi-sectoral documents according to Saibai Blue combing, up to the General Office of the State Council, down to various ministries, to promote the development of innovation and development of Chinese medicine in the continuous progress.
July 23, the General Office of the State Council issued a Notice on the Issue of Key Tasks for Deepening the Reform of the Medical and Health System in the Second Half of 2020, which calls for promoting the revitalization and development of Chinese medicine and playing its unique role in promoting the revitalization and development of Chinese medicine.
to promote the combination of Chinese and Western medicine in general hospitals, infectious disease hospitals, specialized hospitals, etc., and to incorporate the implementation into the hospital grade assessment and performance evaluation.
Speed up the construction of chinese medicine evidence-based medical center, start the construction of the National Chinese Medicine Center and regional Chinese medicine medical center, carry out the pilot construction of chinese medicine classic wards, improve the emergency response and treatment capacity of Chinese medicine hospitals, and play the unique role of Chinese medicine in the treatment of major outbreaks.
selected and released a number of Chinese medicine superior diseases and treatment projects to encourage and guide medical and health institutions to provide Chinese medicine services.
strengthen the county (city) Chinese medicine medical service capacity and team building, and promote the county-run Chinese medicine medical institutions full coverage.
the price adjustment of medical services, we should focus on the price of medical services that reflect the value of technical services, and support the innovation and development of Chinese medicine.
formulate policies and measures to accelerate the development of Chinese medicine characteristics.
(The State Administration of Traditional Chinese Medicine, the National Development and Reform Commission, the National Health And Health Commission and the State Administration of Health Insurance are responsible for each) In addition, recently, the State Administration of Traditional Chinese Medicine issued to the provincial (district, city) Administration of Traditional Chinese Medicine "on the recommendation of Chinese medicine treatment advantages of diseases, appropriate technology and unique efficacy of Chinese medicine species notice."
notice shows that the recommendation is mainly to implement the "CPC Central Committee and the State Council on promoting the heritage and innovation of Chinese medicine" deployment of the relevant tasks - to highlight the advantages of Chinese medicine in disease treatment, as well as vigorously promote the quality of Chinese medicine and high-quality industrial development advice to speed up the construction of Chinese medicine evidence-based medical center, with about 3 years, screening 50 Chinese medicine treatment advantages and 100 appropriate technology, 100 unique efficacy of Chinese medicine, timely release to the community.
(State Administration of Traditional Chinese Medicine, National Health And Health Commission, Ministry of Science and Technology) On the evening of October 26, 2019, the State Council issued the Opinions of the State Council of the CPC Central Committee on Promoting the Innovation and Development of Traditional Chinese Medicine, proposing to vigorously develop Chinese medicine clinics, screen varieties with unique efficacy, promote the improvement of the quality of Chinese medicine, and promote chinese medicine. The 20 development opinions on improving the quality of drinking tablets and traditional Chinese medicine, reforming and perfecting the registration and management of Chinese medicine, strengthening the quality and safety supervision of Chinese medicine, perfecting the price and medical insurance policy of Chinese medicine, strengthening the prevention and rehabilitation role of Chinese medicine, promoting the scientific research and innovation of Chinese medicine, etc., point out the direction for promoting the innovation and development of Chinese medicine inheritance for some time to come.
Subsequently, on December 16, 2019, the State Administration of Traditional Chinese Medicine issued a notice on the priority division of tasks of the State Council of the CPC Central Committee on Promoting the Innovation and Development of Chinese Medicine, mainly in order to implement the Opinions of the State Council of the CPC Central Committee on Promoting the Innovation and Development of Chinese Medicine Heritage.
According to Saibai Blue, the division of labor program involves the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, the member units of the joint inter-ministerial meeting on Chinese medicine under the State Council, the People's Bank of China, the General Administration of Radio and Television, the Chinese Academy of Sciences, the Academy of Engineering, the CSRC, the State Administration of Cultural Relics, the Natural Science Foundation and so on.
this time, the State Drug Administration is from the perspective of drug supervision work to promote the chinese medicine heritage innovation and development of ideas.
that more departments will further promote the implementation of the Opinions of the State Council of the CPC Central Committee on Promoting the Heritage and Innovation of Traditional Chinese Medicine to promote the further development of Chinese medicine.
: The Cpc Central Committee of the State Council on promoting the inheritance and innovation of Chinese medicine, first, improve the Chinese medicine service system (1) to strengthen the construction of Chinese medicine service institutions.
Give full play to the advantages of Chinese medicine as a whole and health medicine, build a National Chinese Medicine Center, regional Chinese medicine medical center as the leader, all kinds of Chinese medicine medical institutions and other medical institutions at all levels of Chinese medicine departments as the backbone, primary health care institutions as the basis for the integration of preventive health care, disease treatment and rehabilitation in one of the Chinese medicine service system, to provide coverage of the whole population and the full life cycle of Chinese medicine services.
Follow the law of the development of Chinese medicine, standardize the setting up of Chinese medicine hospital departments, revise the standards for the setting and construction of Chinese medicine hospitals, improve the evaluation and performance appraisal system, strengthen the mode of operation and service functions based on Chinese medicine services, and establish and improve a modern hospital management system that embodies the characteristics of Chinese medicine.
chinese medicine clinics, out-patient clinics and specialty hospitals to encourage chain management.
the scope of business of enterprises providing chinese medicine health care services shall be expressed in the "Chinese medicine health care services (non-medical)" norm.
to 2022, the basic realization of county-run Chinese medicine medical institutions full coverage, and strive to achieve all community health service centers and township hospitals set up Chinese medicine halls, equipped with Chinese medicine practitioners.
(ii) to build up the grass-roots Chinese medicine service positions.
Expand the scale of rural orders to train Chinese medicine professional medical students free of charge, actively recruit Chinese medicine practitioners in the special post plan for general practitioners, encourage the implementation of Chinese medicine personnel "county management and rural use", encourage retired Chinese medicine practitioners to provide services to the grass-roots level, relax the long-term service of the grass-roots Chinese medicine professional title promotion conditions.
improve the training mechanism for Chinese medicine knowledge and skills of general practitioners and rural doctors.
support chinese medicine hospitals to take the lead in forming a medical complex.
chinese medicine hospitals at all levels should strengthen the guidance of primary Chinese medicine services.
(iii) to information-based support service system construction.
To implement the "Internet plus Chinese Medicine Health Service" initiative, establish a basic database focusing on Chinese medicine electronic medical records, electronic prescriptions, etc., encourage the development of Internet Chinese medicine hospitals relying on medical institutions, develop an intelligent auxiliary diagnosis and treatment system for Chinese medicine, and promote the development of online and offline integrated services and remote medical services.
rely on existing resources to build national and provincial Chinese medicine data centers.
to speed up the establishment of a comprehensive statistical system for Chinese medicine.
improve the comprehensive supervision information system of Chinese medicine, and make comprehensive use of spot checks, spot-point monitoring, illegal and unreal punishment and other means to achieve accurate and efficient supervision.
, play the unique role of Chinese medicine in maintaining and promoting people's health (iv) to highlight the advantages of Chinese medicine in disease treatment.
to strengthen the advantages of Chinese medicine specialty construction, do better and stronger bone injury, intestine, children