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All provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps Drug Administration Bureau, bureaus, organs, departments, and bureaus, all directly subordinate:
The "Several Measures on Further Strengthening the Scientific Supervision of Chinese Medicines and Promoting the Inheritance and Innovation and Development of Chinese Medicines" has been approved by the Director's Office and is hereby issued to you.
State Food and Drug Administration
January 3, 2023
A number of measures to further strengthen the scientific supervision of Chinese medicines and promote the inheritance, innovation and development of Chinese medicines
In order to deeply implement the spirit of the Party, fully implement the major strategic deployment of the report on "strengthening food and drug safety supervision" and "promoting the inheritance and innovative development of traditional Chinese medicine", adhere to the guidance of the thought of socialism with Chinese characteristics in the new era, accurately grasp the new situation, new tasks and new challenges facing the current quality and safety supervision of traditional Chinese medicine and the high-quality development of the traditional Chinese medicine industry, comprehensively strengthen the quality management of the whole industry chain of traditional Chinese medicine, accelerate the review and approval of the whole process, the whole life cycle product services, global regulatory cooperation, To promote the practice of Chinese-style modern drug supervision and the construction of a scientific supervision system for traditional Chinese medicines with Chinese characteristics, the following measures
are specially formulated to promote the scientific supervision practice of Chinese-style drugs in depth.
are specially formulated to promote the scientific supervision practice of Chinese-style drugs in depth.
1.
Strengthen the quality management of Chinese medicinal materials
Strengthen the quality management of Chinese medicinal materials
(1) Standardize the processing
of Chinese medicinal materials in the production areas.
Further mobilize the enthusiasm of local governments, Chinese herbal medicine production enterprises and base farmers in the production areas of Chinese medicinal materials, promote Chinese medicine production enterprises to extend the drug quality management system to the planting and processing of Chinese medicinal materials, and promote the combination
of production and processing of Chinese medicinal materials with ecological civilization construction and rural revitalization.
Provincial-level drug regulatory departments should strengthen the supervision of Chinese medicinal materials purchased by manufacturers of Chinese medicinal pieces (while fresh-cut) Chinese medicinal materials, standardize the processing and procurement of Chinese medicinal materials in the production areas on the basis of complying with the Good Manufacturing Practice for Chinese Medicinal Materials (GAP), and strengthen the quality management
of fresh-cut Chinese medicinal materials.
of Chinese medicinal materials in the production areas.
Further mobilize the enthusiasm of local governments, Chinese herbal medicine production enterprises and base farmers in the production areas of Chinese medicinal materials, promote Chinese medicine production enterprises to extend the drug quality management system to the planting and processing of Chinese medicinal materials, and promote the combination
of production and processing of Chinese medicinal materials with ecological civilization construction and rural revitalization.
Provincial-level drug regulatory departments should strengthen the supervision of Chinese medicinal materials purchased by manufacturers of Chinese medicinal pieces (while fresh-cut) Chinese medicinal materials, standardize the processing and procurement of Chinese medicinal materials in the production areas on the basis of complying with the Good Manufacturing Practice for Chinese Medicinal Materials (GAP), and strengthen the quality management
of fresh-cut Chinese medicinal materials.
(2) Promote the implementation of the Good Manufacturing Practice (GAP)
for Chinese Materia Medica.
Give full play to the important role of GAP in the quality supervision of the production of Chinese medicinal materials, set up a national GAP expert working group, study and improve the implementation work promotion plan and supporting technical requirements, and promote the standardization, industrialization and large-scale planting and breeding
of Chinese medicinal materials.
Through GAP extended inspection, compliance inspection and daily supervision and inspection, promote Chinese medicine manufacturers to adopt self-built, co-built, joint construction or shared Chinese herbal medicine planting and breeding bases, stabilize the supply of Chinese medicinal materials, and use Chinese medicinal materials
that meet the requirements of GAP.
Chinese medicinal materials used in the production of some key or high-risk Chinese medicine varieties shall meet the requirements of
GAP by variety and step-by-step research.
In principle, the Chinese medicinal materials used in the production of Chinese medicine injections shall meet the requirements
of GAP.
for Chinese Materia Medica.
Give full play to the important role of GAP in the quality supervision of the production of Chinese medicinal materials, set up a national GAP expert working group, study and improve the implementation work promotion plan and supporting technical requirements, and promote the standardization, industrialization and large-scale planting and breeding
of Chinese medicinal materials.
Through GAP extended inspection, compliance inspection and daily supervision and inspection, promote Chinese medicine manufacturers to adopt self-built, co-built, joint construction or shared Chinese herbal medicine planting and breeding bases, stabilize the supply of Chinese medicinal materials, and use Chinese medicinal materials
that meet the requirements of GAP.
Chinese medicinal materials used in the production of some key or high-risk Chinese medicine varieties shall meet the requirements of
GAP by variety and step-by-step research.
In principle, the Chinese medicinal materials used in the production of Chinese medicine injections shall meet the requirements
of GAP.
(3) Improve the registration and management
of Chinese medicinal materials.
In conjunction with the State Administration of Traditional Chinese Medicine, the "Catalogue of Chinese Materia Medica Varieties for Examination and Approval Management" is formulated to implement approval and management
of Chinese medicinal materials varieties that meet the prescribed circumstances in accordance with the law.
Strengthen the management of regional folk customary medicinal materials, revise the Measures for the Management of Regional Folk Customary Medicinal Materials, guide provincial-level drug regulatory departments in formulating and revising regional folk customary medicinal materials standards, and ensure that local medicinal material standards are coordinated and unified
with national drug standards.
of Chinese medicinal materials.
In conjunction with the State Administration of Traditional Chinese Medicine, the "Catalogue of Chinese Materia Medica Varieties for Examination and Approval Management" is formulated to implement approval and management
of Chinese medicinal materials varieties that meet the prescribed circumstances in accordance with the law.
Strengthen the management of regional folk customary medicinal materials, revise the Measures for the Management of Regional Folk Customary Medicinal Materials, guide provincial-level drug regulatory departments in formulating and revising regional folk customary medicinal materials standards, and ensure that local medicinal material standards are coordinated and unified
with national drug standards.
(4) Establish a working mechanism
for monitoring the quality of Chinese medicinal materials.
Organize comprehensive analysis of the quality monitoring data of Chinese medicinal materials, pay attention to the differences in the amount of Chinese medicinal materials in different production areas, and research and release the quality monitoring report
of Chinese medicinal materials.
Establish a national basic database on the quality of Chinese medicinal materials covering information such as the research, origin, quality, and safety of medicinal materials, and promote the sharing and sharing of data and information
of Chinese medicinal materials.
for monitoring the quality of Chinese medicinal materials.
Organize comprehensive analysis of the quality monitoring data of Chinese medicinal materials, pay attention to the differences in the amount of Chinese medicinal materials in different production areas, and research and release the quality monitoring report
of Chinese medicinal materials.
Establish a national basic database on the quality of Chinese medicinal materials covering information such as the research, origin, quality, and safety of medicinal materials, and promote the sharing and sharing of data and information
of Chinese medicinal materials.
(5) Improve the management of
imports of Chinese medicinal materials.
Continue to strengthen the capacity building of inspection of imported medicinal materials and improve the quality traceability level of
imported medicinal materials.
In accordance with the requirements of the national strategic regional planning, orderly carry out on-site assessment and assessment of ports that apply for the addition of ports that allow the import of drugs or border ports that allow the import of medicinal materials, and reasonably add ports that allow the import of drugs or border ports that allow the import of medicinal materials
.
imports of Chinese medicinal materials.
Continue to strengthen the capacity building of inspection of imported medicinal materials and improve the quality traceability level of
imported medicinal materials.
In accordance with the requirements of the national strategic regional planning, orderly carry out on-site assessment and assessment of ports that apply for the addition of ports that allow the import of drugs or border ports that allow the import of medicinal materials, and reasonably add ports that allow the import of drugs or border ports that allow the import of medicinal materials
.
2.
Strengthen the supervision of Chinese medicine pieces and Chinese medicine formula granules
Strengthen the supervision of Chinese medicine pieces and Chinese medicine formula granules
(6) Strengthen the approval and management of
Chinese medicine pieces.
Follow the theory and medication rules of traditional Chinese medicine, focus on quality and safety risks, promote the research on the processing mechanism of traditional Chinese medicine pieces, and establish and improve the quality evaluation system
of traditional Chinese medicine pieces.
In conjunction with the State Administration of Traditional Chinese Medicine, the "Catalogue of Chinese Medicine Pieces Implementing Approval Management" and supporting documents shall be formulated to implement the examination and approval management
of Chinese medicine pieces that meet the prescribed circumstances in accordance with the law.
Chinese medicine pieces.
Follow the theory and medication rules of traditional Chinese medicine, focus on quality and safety risks, promote the research on the processing mechanism of traditional Chinese medicine pieces, and establish and improve the quality evaluation system
of traditional Chinese medicine pieces.
In conjunction with the State Administration of Traditional Chinese Medicine, the "Catalogue of Chinese Medicine Pieces Implementing Approval Management" and supporting documents shall be formulated to implement the examination and approval management
of Chinese medicine pieces that meet the prescribed circumstances in accordance with the law.
(7) Improve the specifications for the preparation of
Chinese medicine pieces.
Publish, implement and continuously improve the National Standards for the Processing of Chinese Medicine Pieces in batches, strengthen the filing management of the provincial specifications for the preparation of Chinese medicine pieces, and guide the formulation and revision
of the provincial specifications for the processing of Chinese medicine pieces.
Strengthen the supervision and implementation of provincial-level specifications for the processing of Chinese medicine pieces, and improve the regulations
on the production, circulation, and use management of the production of Chinese medicine pieces in accordance with the provincial specifications for the processing of Chinese medicine pieces.
Chinese medicine pieces.
Publish, implement and continuously improve the National Standards for the Processing of Chinese Medicine Pieces in batches, strengthen the filing management of the provincial specifications for the preparation of Chinese medicine pieces, and guide the formulation and revision
of the provincial specifications for the processing of Chinese medicine pieces.
Strengthen the supervision and implementation of provincial-level specifications for the processing of Chinese medicine pieces, and improve the regulations
on the production, circulation, and use management of the production of Chinese medicine pieces in accordance with the provincial specifications for the processing of Chinese medicine pieces.
(8) Standardize the production and quality traceability
of Chinese medicine pieces.
Follow the characteristics of the processing of Chinese medicine pieces, combine traditional processing methods and modern production technology and means, study and improve the quality management standards for the production of Chinese medicine pieces, explore the establishment of a traceability system for the production and circulation of Chinese medicine pieces, and gradually realize the traceability of the source of key varieties, the traceability of the whereabouts and the mutual sharing
of traceability information.
Issued and implemented the "Provisions on the Administration of Packaging and Labeling of Chinese Medicine Pieces (for Trial Implementation)" and related supporting technical documents to standardize the labeling content
of Chinese medicine pieces.
of Chinese medicine pieces.
Follow the characteristics of the processing of Chinese medicine pieces, combine traditional processing methods and modern production technology and means, study and improve the quality management standards for the production of Chinese medicine pieces, explore the establishment of a traceability system for the production and circulation of Chinese medicine pieces, and gradually realize the traceability of the source of key varieties, the traceability of the whereabouts and the mutual sharing
of traceability information.
Issued and implemented the "Provisions on the Administration of Packaging and Labeling of Chinese Medicine Pieces (for Trial Implementation)" and related supporting technical documents to standardize the labeling content
of Chinese medicine pieces.
(9) Promote the improvement of the production and operation mode
of Chinese medicine pieces.
Guide and urge Chinese medicine pieces manufacturers to optimize and adjust the production structure of varieties in combination with industrial planning, resource advantages, technical capabilities and other production conditions, and gradually promote the realization of intensive, high-quality and large-scale production modes
of Chinese medicine pieces.
of Chinese medicine pieces.
Guide and urge Chinese medicine pieces manufacturers to optimize and adjust the production structure of varieties in combination with industrial planning, resource advantages, technical capabilities and other production conditions, and gradually promote the realization of intensive, high-quality and large-scale production modes
of Chinese medicine pieces.
(10) Strengthen the management
of the production process of granules formulated with traditional Chinese medicine.
Supervise and urge Chinese medicine formula granule manufacturers to produce in strict accordance with the recorded production process, strictly review suppliers, strengthen the quality management of the whole link such as identification of Chinese medicinal materials, processing of Chinese medicine pieces, granule production, inspection and release, etc.
, to ensure that the whole production process complies with the corresponding drug standards and drug production quality management practices
.
of the production process of granules formulated with traditional Chinese medicine.
Supervise and urge Chinese medicine formula granule manufacturers to produce in strict accordance with the recorded production process, strictly review suppliers, strengthen the quality management of the whole link such as identification of Chinese medicinal materials, processing of Chinese medicine pieces, granule production, inspection and release, etc.
, to ensure that the whole production process complies with the corresponding drug standards and drug production quality management practices
.
3.
Optimize the management of traditional Chinese medicine preparations in medical institutions
Optimize the management of traditional Chinese medicine preparations in medical institutions
(11) Actively give play to the role of
traditional Chinese medicine preparations in medical institutions.
Promote medical institutions to use big data, artificial intelligence, real-world research and other technical means to carry out research
on traditional Chinese medicine preparations in medical institutions around clinical positioning, applicable population, usage and dosage, course of treatment, and evaluation indicators that reflect the characteristics and advantages of traditional Chinese medicine.
Give full play to the supporting role of human experience in the safety and effectiveness of traditional Chinese medicine preparations in medical institutions, and support the transformation
of traditional Chinese medicine preparations in medical institutions with precise curative effects, obvious characteristic advantages, and few adverse reactions into new drugs.
traditional Chinese medicine preparations in medical institutions.
Promote medical institutions to use big data, artificial intelligence, real-world research and other technical means to carry out research
on traditional Chinese medicine preparations in medical institutions around clinical positioning, applicable population, usage and dosage, course of treatment, and evaluation indicators that reflect the characteristics and advantages of traditional Chinese medicine.
Give full play to the supporting role of human experience in the safety and effectiveness of traditional Chinese medicine preparations in medical institutions, and support the transformation
of traditional Chinese medicine preparations in medical institutions with precise curative effects, obvious characteristic advantages, and few adverse reactions into new drugs.
(12) Strictly record and transfer the use of traditional Chinese medicine preparations
in medical institutions.
Carry out the filing and management of traditional Chinese medicine preparations prepared by medical institutions using traditional techniques in strict accordance with regulations, promptly conduct data verification and on-site inspections of the preparations of medical institutions that have been recorded, and carry out sampling inspections
in accordance with relevant provisions when necessary.
Standardize the use of traditional Chinese medicine preparations in medical institutions, and support the implementation of multi-center clinical research
in different medical institutions through transfer.
The provincial-level drug regulatory departments refer to the "Good Manufacturing Practice" and other relevant provisions to standardize and strengthen the supervision of regional preparation workshops of traditional Chinese medicine preparations in medical institutions, and strictly supervise the quality of
traditional Chinese medicine preparations prepared by them.
in medical institutions.
Carry out the filing and management of traditional Chinese medicine preparations prepared by medical institutions using traditional techniques in strict accordance with regulations, promptly conduct data verification and on-site inspections of the preparations of medical institutions that have been recorded, and carry out sampling inspections
in accordance with relevant provisions when necessary.
Standardize the use of traditional Chinese medicine preparations in medical institutions, and support the implementation of multi-center clinical research
in different medical institutions through transfer.
The provincial-level drug regulatory departments refer to the "Good Manufacturing Practice" and other relevant provisions to standardize and strengthen the supervision of regional preparation workshops of traditional Chinese medicine preparations in medical institutions, and strictly supervise the quality of
traditional Chinese medicine preparations prepared by them.
(13) Strengthen the monitoring
of adverse reactions to traditional Chinese medicine preparations in medical institutions.
Promote medical establishments to establish and improve pharmacovigilance systems, actively carry out monitoring, identification, assessment and control of suspected adverse reactions of traditional Chinese medicine preparations in medical establishments, and when necessary, carry out research and comprehensive evaluation of the effectiveness and safety of traditional Chinese medicine preparations in medical establishments, and actively apply to the local provincial drug regulatory department for cancellation of relevant approval documents or cancellation of
filings for inaccurate efficacy, large adverse reactions, or other reasons that endanger human health.
of adverse reactions to traditional Chinese medicine preparations in medical institutions.
Promote medical establishments to establish and improve pharmacovigilance systems, actively carry out monitoring, identification, assessment and control of suspected adverse reactions of traditional Chinese medicine preparations in medical establishments, and when necessary, carry out research and comprehensive evaluation of the effectiveness and safety of traditional Chinese medicine preparations in medical establishments, and actively apply to the local provincial drug regulatory department for cancellation of relevant approval documents or cancellation of
filings for inaccurate efficacy, large adverse reactions, or other reasons that endanger human health.
4.
Improve the review and approval mechanism for traditional Chinese medicines
Improve the review and approval mechanism for traditional Chinese medicines
(14) Continue to promote the research and innovation
of the evaluation system of traditional Chinese medicines.
Optimize the review and approval system and mechanism for traditional Chinese medicines, accelerate the whole process of accelerating the "end" of registration to extending to the "front end", formulate and publish and implement the Special Provisions on the Registration and Administration of Traditional Chinese Medicines, accelerate the construction of the "three combinations" review evidence system of traditional Chinese medicine theory, human experience and clinical trials, and establish and improve diversified technical standards for the evaluation of traditional Chinese medicines and clinical efficacy evaluation methods
oriented by clinical value.
of the evaluation system of traditional Chinese medicines.
Optimize the review and approval system and mechanism for traditional Chinese medicines, accelerate the whole process of accelerating the "end" of registration to extending to the "front end", formulate and publish and implement the Special Provisions on the Registration and Administration of Traditional Chinese Medicines, accelerate the construction of the "three combinations" review evidence system of traditional Chinese medicine theory, human experience and clinical trials, and establish and improve diversified technical standards for the evaluation of traditional Chinese medicines and clinical efficacy evaluation methods
oriented by clinical value.
(15) Improve the emergency review and approval mechanism
for traditional Chinese medicines.
Respond quickly and effectively to public health emergencies, and implement special approval procedures
for Chinese medicines that are determined to be urgently needed by the health or traditional Chinese medicine administration department under the State Council.
Encourage and support the development of new traditional Chinese medicines for major diseases, rare diseases, or children, and give priority to the review and approval
of relevant registration applications that meet the prescribed circumstances.
for traditional Chinese medicines.
Respond quickly and effectively to public health emergencies, and implement special approval procedures
for Chinese medicines that are determined to be urgently needed by the health or traditional Chinese medicine administration department under the State Council.
Encourage and support the development of new traditional Chinese medicines for major diseases, rare diseases, or children, and give priority to the review and approval
of relevant registration applications that meet the prescribed circumstances.
(16) Improve the categorical management
of prescription and non-prescription Chinese medicines.
Optimize the technical guiding principles system and requirements related to the marketing registration and post-marketing conversion of OTC drugs, standardize the technical evaluation of the conversion of prescription drugs of traditional Chinese medicines into over-the-counter drugs, research and formulate technical requirements for the review of non-prescription drugs of traditional Chinese medicines, and further give play to the role of
proprietary Chinese medicines in self-treatment.
of prescription and non-prescription Chinese medicines.
Optimize the technical guiding principles system and requirements related to the marketing registration and post-marketing conversion of OTC drugs, standardize the technical evaluation of the conversion of prescription drugs of traditional Chinese medicines into over-the-counter drugs, research and formulate technical requirements for the review of non-prescription drugs of traditional Chinese medicines, and further give play to the role of
proprietary Chinese medicines in self-treatment.
5.
Attach importance to the post-marketing management of traditional Chinese medicines
Attach importance to the post-marketing management of traditional Chinese medicines
(17) Improve the post-marketing management mechanism
of traditional Chinese medicines.
Strengthen the full life cycle service of drugs, urge drug marketing authorization holders to perform their main responsibilities and obligations, formulate post-marketing risk management plans based on product characteristics, actively carry out post-marketing research and post-market evaluation, and conduct comprehensive analysis and assessment
of the benefits and risks of drugs.
According to the assessment results, measures such as amending drug instructions, suspending production and sales, recalling drugs, and actively applying for cancellation of drug approval documents are taken in accordance with the law
.
Supervise and urge drug marketing authorization holders to take the initiative to carry out post-marketing research and evaluation of traditional Chinese medicine injections, and continuously improve the pharmacovigilance level and ability
of traditional Chinese medicine injections.
of traditional Chinese medicines.
Strengthen the full life cycle service of drugs, urge drug marketing authorization holders to perform their main responsibilities and obligations, formulate post-marketing risk management plans based on product characteristics, actively carry out post-marketing research and post-market evaluation, and conduct comprehensive analysis and assessment
of the benefits and risks of drugs.
According to the assessment results, measures such as amending drug instructions, suspending production and sales, recalling drugs, and actively applying for cancellation of drug approval documents are taken in accordance with the law
.
Supervise and urge drug marketing authorization holders to take the initiative to carry out post-marketing research and evaluation of traditional Chinese medicine injections, and continuously improve the pharmacovigilance level and ability
of traditional Chinese medicine injections.
(18) Strengthen the management
of post-marketing changes of traditional Chinese medicines.
Improve post-listing change management based on risk control, further clarify the criteria for different change risk levels, and strengthen the review and approval
of high-risk change varieties.
Strengthen the awareness of the main responsibility of drug MAHs to actively improve the quality of traditional Chinese medicines, give play to the advantages of end-of-line policies, and improve the ability of drug MAHs to manage the whole life cycle of products
.
of post-marketing changes of traditional Chinese medicines.
Improve post-listing change management based on risk control, further clarify the criteria for different change risk levels, and strengthen the review and approval
of high-risk change varieties.
Strengthen the awareness of the main responsibility of drug MAHs to actively improve the quality of traditional Chinese medicines, give play to the advantages of end-of-line policies, and improve the ability of drug MAHs to manage the whole life cycle of products
.
(19) Strengthen the monitoring of
adverse reactions of traditional Chinese medicines.
Organize research and development of monitoring tools for adverse reaction signals of traditional Chinese medicines that meet the characteristics of traditional Chinese medicines, promptly carry out comprehensive analysis and judgment of the safety risk signals found, adopt corresponding risk control measures, strengthen the monitoring and handling of adverse reaction clustering events, and timely prevent and control drug risks
.
adverse reactions of traditional Chinese medicines.
Organize research and development of monitoring tools for adverse reaction signals of traditional Chinese medicines that meet the characteristics of traditional Chinese medicines, promptly carry out comprehensive analysis and judgment of the safety risk signals found, adopt corresponding risk control measures, strengthen the monitoring and handling of adverse reaction clustering events, and timely prevent and control drug risks
.
6.
Improve the standard management level of traditional Chinese medicine
Improve the standard management level of traditional Chinese medicine
(20) Optimize the management
of Chinese medicine standards.
Research and formulate special regulations
for the management of Chinese medicine standards.
Take the revision of the Chinese Pharmacopoeia (Part I) as an opportunity to explore the implementation of national standards for traditional Chinese medicines, formulate quality management practices, and timely transform scientific, mature and applicable relevant registration standards, international standards, group standards or enterprise internal control standards into national standards
.
Establish a rapid revision mechanism and revision procedure
for national standards for traditional Chinese medicine.
Strengthen the construction of the Pharmacopoeia Committee's special committees related to Chinese medicines, and improve the mechanism for selecting and selecting members
.
of Chinese medicine standards.
Research and formulate special regulations
for the management of Chinese medicine standards.
Take the revision of the Chinese Pharmacopoeia (Part I) as an opportunity to explore the implementation of national standards for traditional Chinese medicines, formulate quality management practices, and timely transform scientific, mature and applicable relevant registration standards, international standards, group standards or enterprise internal control standards into national standards
.
Establish a rapid revision mechanism and revision procedure
for national standards for traditional Chinese medicine.
Strengthen the construction of the Pharmacopoeia Committee's special committees related to Chinese medicines, and improve the mechanism for selecting and selecting members
.
(21) Scientifically improve standards
for traditional Chinese medicine.
Continue to promote the formulation and revision of traditional Chinese medicine standards, and accelerate the release and implementation
of national standards for the preparation of traditional Chinese medicine pieces and standards for traditional Chinese medicine formula granules.
Reasonably set the limit requirements and detection methods
for pesticide residues, heavy metals and harmful elements, mycotoxins and other harmful substances in traditional Chinese medicine, as well as plant growth regulators.
Strengthen the research and risk assessment system for the detection technology of endogenous toxic ingredients in traditional Chinese medicines, formulate standards for the limits of endogenous toxic ingredients that meet the characteristics of traditional Chinese medicines, and improve the usage and dosage
.
for traditional Chinese medicine.
Continue to promote the formulation and revision of traditional Chinese medicine standards, and accelerate the release and implementation
of national standards for the preparation of traditional Chinese medicine pieces and standards for traditional Chinese medicine formula granules.
Reasonably set the limit requirements and detection methods
for pesticide residues, heavy metals and harmful elements, mycotoxins and other harmful substances in traditional Chinese medicine, as well as plant growth regulators.
Strengthen the research and risk assessment system for the detection technology of endogenous toxic ingredients in traditional Chinese medicines, formulate standards for the limits of endogenous toxic ingredients that meet the characteristics of traditional Chinese medicines, and improve the usage and dosage
.
(22) Strengthen the development and supply guarantee
of reference materials for traditional Chinese medicines.
Improve the mechanism for the development and continuous supply of Chinese medicine reference materials, strengthen the dynamic early warning and information feedback mechanism, carry out demand analysis and formulate development plans, and strengthen quality monitoring
.
Classify and improve the technical requirements
for the development and calibration of traditional Chinese medicine standard substances such as chemical reference substances, control medicinal materials and control extracts of traditional Chinese medicines.
of reference materials for traditional Chinese medicines.
Improve the mechanism for the development and continuous supply of Chinese medicine reference materials, strengthen the dynamic early warning and information feedback mechanism, carry out demand analysis and formulate development plans, and strengthen quality monitoring
.
Classify and improve the technical requirements
for the development and calibration of traditional Chinese medicine standard substances such as chemical reference substances, control medicinal materials and control extracts of traditional Chinese medicines.
(23) Improve the level of
digital management of Chinese medicine standards.
Establish and improve the dynamic database of national drug standards and drug registration standards for traditional Chinese medicines, accelerate the construction of digital standards, update data in a timely manner, and realize the informatization
of the release, query, analysis, research and maintenance of drug standards.
digital management of Chinese medicine standards.
Establish and improve the dynamic database of national drug standards and drug registration standards for traditional Chinese medicines, accelerate the construction of digital standards, update data in a timely manner, and realize the informatization
of the release, query, analysis, research and maintenance of drug standards.
7.
Strengthen the supervision of the safety of traditional Chinese medicines
Strengthen the supervision of the safety of traditional Chinese medicines
(24) Innovate the quality supervision model
of traditional Chinese medicines.
Gradually build a "grid" supervision model, improve the construction of the supervision system for the production of traditional Chinese medicines, and research, formulate and supervise the implementation of the Good Manufacturing Practice for Traditional Chinese
Medicines.
Gradually establish and improve the risk research and judgment mechanism for regionalization of traditional Chinese medicine production, continuously strengthen the supervision and inspection of traditional Chinese medicine pieces, traditional Chinese medicine formula granules and proprietary Chinese medicines for key enterprises, key varieties and key links, and carry out extended inspections of traditional Chinese medicinal materials in an orderly manner
.
Further standardize the circulation and operation order of Chinese medicine pieces, Chinese medicine formula granules and proprietary Chinese medicines, and strengthen the quality supervision
of the use link.
of traditional Chinese medicines.
Gradually build a "grid" supervision model, improve the construction of the supervision system for the production of traditional Chinese medicines, and research, formulate and supervise the implementation of the Good Manufacturing Practice for Traditional Chinese
Medicines.
Gradually establish and improve the risk research and judgment mechanism for regionalization of traditional Chinese medicine production, continuously strengthen the supervision and inspection of traditional Chinese medicine pieces, traditional Chinese medicine formula granules and proprietary Chinese medicines for key enterprises, key varieties and key links, and carry out extended inspections of traditional Chinese medicinal materials in an orderly manner
.
Further standardize the circulation and operation order of Chinese medicine pieces, Chinese medicine formula granules and proprietary Chinese medicines, and strengthen the quality supervision
of the use link.
(25) Strengthen sampling and monitoring
of the quality of traditional Chinese medicines.
Continue to promote and improve the quality sampling of Chinese medicine pieces, Chinese medicine formula granules and proprietary Chinese medicines, carry out exploratory research in combination with regulatory needs and the actual development of the industry, conduct comprehensive analysis and judgment of sampling monitoring data, take corresponding risk prevention and control or quality improvement measures according to risks, optimize the working mechanism for the release of Chinese medicine quality announcements, release sampling and monitoring results in accordance with the law, and objectively and accurately transmit quality and safety information
of Chinese medicines to the public.
of the quality of traditional Chinese medicines.
Continue to promote and improve the quality sampling of Chinese medicine pieces, Chinese medicine formula granules and proprietary Chinese medicines, carry out exploratory research in combination with regulatory needs and the actual development of the industry, conduct comprehensive analysis and judgment of sampling monitoring data, take corresponding risk prevention and control or quality improvement measures according to risks, optimize the working mechanism for the release of Chinese medicine quality announcements, release sampling and monitoring results in accordance with the law, and objectively and accurately transmit quality and safety information
of Chinese medicines to the public.
(26) Strictly crack down on violations of
laws and regulations.
Strictly investigate and punish drug marketing authorization holders, manufacturers and/or operating enterprises suspected of registration, filing fraud, adulteration, fabrication of records, illegal sales and other violations of laws and regulations in accordance with the law
.
Strictly crack down on illegal and criminal activities such as the manufacture and sale of counterfeit Chinese medicines in "dens", make full use of clues such as network monitoring, complaints and reports, and cooperate with public security, judicial and other departments to resolutely investigate the source and pursue them to the end, pursue the criminal responsibility of criminals in accordance with the law, and adhere to the bottom line
of Chinese medicine safety.
laws and regulations.
Strictly investigate and punish drug marketing authorization holders, manufacturers and/or operating enterprises suspected of registration, filing fraud, adulteration, fabrication of records, illegal sales and other violations of laws and regulations in accordance with the law
.
Strictly crack down on illegal and criminal activities such as the manufacture and sale of counterfeit Chinese medicines in "dens", make full use of clues such as network monitoring, complaints and reports, and cooperate with public security, judicial and other departments to resolutely investigate the source and pursue them to the end, pursue the criminal responsibility of criminals in accordance with the law, and adhere to the bottom line
of Chinese medicine safety.
8.
Promote global cooperation in the supervision of traditional Chinese medicines
Promote global cooperation in the supervision of traditional Chinese medicines
(27) Give full play to the role of
international cooperation platforms.
Further deepen international cooperation between the World Health Organization (WHO), the International Cooperative Organization for Herbal Medicines Regulation (IRCH), and the Western Pacific Regional Forum for Coordination of Herbal Medicine Regulation (FHH), give full play to the role of platforms such as the "One Belt, One Road" international cooperation framework, the "China-ASEAN Summit Forum on Drug Cooperation and Development", and the World Health Organization Cooperation Center for Traditional Medicine, and actively promote the formation of international consensus
on regulatory cooperation and standard coordination of traditional herbal medicines.
international cooperation platforms.
Further deepen international cooperation between the World Health Organization (WHO), the International Cooperative Organization for Herbal Medicines Regulation (IRCH), and the Western Pacific Regional Forum for Coordination of Herbal Medicine Regulation (FHH), give full play to the role of platforms such as the "One Belt, One Road" international cooperation framework, the "China-ASEAN Summit Forum on Drug Cooperation and Development", and the World Health Organization Cooperation Center for Traditional Medicine, and actively promote the formation of international consensus
on regulatory cooperation and standard coordination of traditional herbal medicines.
(28) Support the international registration
of traditional Chinese medicines.
Actively carry out publicity and exchange of policies for the international registration of traditional Chinese medicines, support the international registration of traditional Chinese medicines with clinical advantages in China, and encourage the development of international multi-center clinical trials
of traditional Chinese medicines.
Organize inspections of the production sites such as the origin and primary processing of imported medicinal materials, as well as the development and production of overseas traditional Chinese medicines (natural medicines) according to the plan
.
of traditional Chinese medicines.
Actively carry out publicity and exchange of policies for the international registration of traditional Chinese medicines, support the international registration of traditional Chinese medicines with clinical advantages in China, and encourage the development of international multi-center clinical trials
of traditional Chinese medicines.
Organize inspections of the production sites such as the origin and primary processing of imported medicinal materials, as well as the development and production of overseas traditional Chinese medicines (natural medicines) according to the plan
.
(29) Disseminate the "Chinese experience"
in the supervision of traditional Chinese medicines.
Accelerate the translation of relevant policies, regulations and technical guidelines for the supervision of traditional Chinese medicines, print foreign language versions of the technical guidelines related to traditional Chinese medicines in batches, accelerate international promotion, and contribute "Chinese experience"
to the formulation and revision of international regulatory rules and standards for traditional herbal medicines.
in the supervision of traditional Chinese medicines.
Accelerate the translation of relevant policies, regulations and technical guidelines for the supervision of traditional Chinese medicines, print foreign language versions of the technical guidelines related to traditional Chinese medicines in batches, accelerate international promotion, and contribute "Chinese experience"
to the formulation and revision of international regulatory rules and standards for traditional herbal medicines.
9.
Safeguard Measures
Safeguard Measures
(30) Strengthen departmental linkage and coordinated advancement
.
Strengthen coordination and linkage with the Health Commission, the Medical Insurance Bureau, the Chinese Medicine Bureau and other departments, strengthen communication and exchanges in the process of formulating major policies related to Chinese medicine, and form a good situation
for all departments to jointly promote the inheritance, innovation and development of Chinese medicine.
.
Strengthen coordination and linkage with the Health Commission, the Medical Insurance Bureau, the Chinese Medicine Bureau and other departments, strengthen communication and exchanges in the process of formulating major policies related to Chinese medicine, and form a good situation
for all departments to jointly promote the inheritance, innovation and development of Chinese medicine.
(31) Vigorously develop the science
of supervision of traditional Chinese medicines.
Research and formulate the scientific development strategy and key path of traditional Chinese medicine supervision, and promote the implementation of the State Food and Drug Administration's scientific action plan
for drug supervision.
Actively prepare for the establishment of the National Key Laboratory of Drug Regulatory Science, rely on the implementation of the drug regulatory science base, key laboratories and key projects of the State Food and Drug Administration, promote the research of new tools, new methods and new standards for the evaluation of traditional Chinese medicines, establish and promote their transformation and identification procedures for the supervision of traditional Chinese medicines, establish and improve the scientific system of traditional Chinese medicine supervision with Chinese characteristics, and solve the basic, critical, cutting-edge and strategic technical problems
of traditional Chinese medicine supervision.
of supervision of traditional Chinese medicines.
Research and formulate the scientific development strategy and key path of traditional Chinese medicine supervision, and promote the implementation of the State Food and Drug Administration's scientific action plan
for drug supervision.
Actively prepare for the establishment of the National Key Laboratory of Drug Regulatory Science, rely on the implementation of the drug regulatory science base, key laboratories and key projects of the State Food and Drug Administration, promote the research of new tools, new methods and new standards for the evaluation of traditional Chinese medicines, establish and promote their transformation and identification procedures for the supervision of traditional Chinese medicines, establish and improve the scientific system of traditional Chinese medicine supervision with Chinese characteristics, and solve the basic, critical, cutting-edge and strategic technical problems
of traditional Chinese medicine supervision.
(xxxii) Strengthen the construction of
high-end think tanks.
Give full play to the role of high-end think tanks, set up an expert advisory committee on strategic decision-making on the management of traditional Chinese medicines composed of academicians, masters of traditional Chinese medicine and senior experts in the field of traditional Chinese medicine and other related disciplines, establish an expert group on scientific work on the supervision of traditional Chinese medicines, provide relevant policy and legal advice to the State Food and Drug Administration, put forward decision-making references and work suggestions, and ensure the scientific and authoritative nature of major decisions in the supervision of traditional Chinese
medicines.
high-end think tanks.
Give full play to the role of high-end think tanks, set up an expert advisory committee on strategic decision-making on the management of traditional Chinese medicines composed of academicians, masters of traditional Chinese medicine and senior experts in the field of traditional Chinese medicine and other related disciplines, establish an expert group on scientific work on the supervision of traditional Chinese medicines, provide relevant policy and legal advice to the State Food and Drug Administration, put forward decision-making references and work suggestions, and ensure the scientific and authoritative nature of major decisions in the supervision of traditional Chinese
medicines.
(33) Attach importance to the cultivation of
regulatory science talents.
Strengthen cooperation with high-level research institutions, colleges and universities, industry societies, research societies, etc.
, build a training course system for Chinese medicine regulatory talents, carry out regulatory capabilities and practical training by category, and cultivate a regulatory team
that adapts to the high-quality development of Chinese medicine.
regulatory science talents.
Strengthen cooperation with high-level research institutions, colleges and universities, industry societies, research societies, etc.
, build a training course system for Chinese medicine regulatory talents, carry out regulatory capabilities and practical training by category, and cultivate a regulatory team
that adapts to the high-quality development of Chinese medicine.
(xxxiv) Consolidate the regulatory infrastructure of traditional Chinese
medicines.
Strengthen the construction of basic data for the supervision of traditional Chinese medicines, carry out data scientific research, and promote the construction of a data-centered smart supervision model
for traditional Chinese medicines from the aspects of technical standards, quality traceability, process monitoring, and risk monitoring.
medicines.
Strengthen the construction of basic data for the supervision of traditional Chinese medicines, carry out data scientific research, and promote the construction of a data-centered smart supervision model
for traditional Chinese medicines from the aspects of technical standards, quality traceability, process monitoring, and risk monitoring.
(xxxv) Fully implement national and regional strategies
.
Implement and promote national regional development strategies such as "Beijing-Tianjin-Hebei coordinated development", "regional integration of the Yangtze River Delta" and "construction of the Guangdong-Hong Kong-Macao Greater Bay Area" and the construction of demonstration zones for comprehensive reform of traditional Chinese medicine, and encourage drug regulatory departments in regions with mature conditions to take the lead in strengthening the supervision of the quality and safety of traditional Chinese medicines and promoting the higher-quality development of the traditional Chinese medicine industry
.
.
Implement and promote national regional development strategies such as "Beijing-Tianjin-Hebei coordinated development", "regional integration of the Yangtze River Delta" and "construction of the Guangdong-Hong Kong-Macao Greater Bay Area" and the construction of demonstration zones for comprehensive reform of traditional Chinese medicine, and encourage drug regulatory departments in regions with mature conditions to take the lead in strengthening the supervision of the quality and safety of traditional Chinese medicines and promoting the higher-quality development of the traditional Chinese medicine industry
.
