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The full text of People's Republic of China (PRC) Traditional Chinese Medicine Law
People's Republic of China (PRC) Traditional Chinese Medicine Law (Draft for Comment)

Chapter I General Principles

Article 1 This Law is formulated for the purpose of inheriting and promoting Chinese medicine, ensuring and promoting the development of Chinese medicine and protecting human health.

Article 2 Traditional Chinese medicine referred to in this Law, that is, China traditional medicine, is the general name of the medicines of all ethnic groups in China, and it is a medical system that reflects the people's understanding of health and diseases in China and has specific theories and cultural characteristics in China.

Traditional Chinese medicine is the characteristic and advantage of China's medical and health system and an important part of the national medical and health undertakings.

Article 3 The State adheres to the principle of attaching equal importance to both Chinese and Western medicine and gives full play to the role of Chinese medicine in medical and health undertakings.

Article 4 The development of traditional Chinese medicine should follow its own laws and establish a management system that conforms to the characteristics of traditional Chinese medicine. Adhere to inheritance and innovation, maintain and give play to the characteristics and advantages of traditional Chinese medicine; Adhere to overall planning and promote the comprehensive and coordinated development of traditional Chinese medicine; Adhere to the mutual learning of Chinese and western medicine, encourage western medicine to learn Chinese medicine, and promote the integration of Chinese and western medicine.

Article 5 The State encourages and supports social forces to invest in Chinese medicine, and takes measures to support organizations and individuals to donate Chinese medicine.

Article 6 The State encourages and supports foreign exchanges and cooperation of traditional Chinese medicine, and promotes the international spread and application of traditional Chinese medicine.

Article 7 The State develops the culture of traditional Chinese medicine and incorporates the construction of traditional Chinese medicine culture into the national cultural development plan.

Every year, 65438+ 10 month 1 1 is "Chinese medicine day".

Article 8 The competent department of traditional Chinese medicine in the State Council is responsible for the administration of traditional Chinese medicine throughout the country. Other relevant departments in the State Council are responsible for the work related to the management of traditional Chinese medicine within their respective functions and duties.

The competent departments of traditional Chinese medicine of local people's governments at or above the county level shall be responsible for the administration of traditional Chinese medicine within their respective administrative areas. Other relevant departments of the local people's governments at or above the county level shall be responsible for the work related to the administration of traditional Chinese medicine within the scope of their respective duties.

Ninth people's governments at or above the county level shall establish a coordination mechanism for the work of traditional Chinese medicine to solve major problems in the development of traditional Chinese medicine.

Tenth organizations and individuals that have made outstanding contributions to the development of Chinese medicine shall be commended and rewarded in accordance with the relevant provisions of the state.

Chapter II Traditional Chinese Medicine Services

Eleventh to carry out Chinese medicine prevention, health care, medical care and rehabilitation services, should be guided by the theory of Chinese medicine, the use of Chinese medicine technology.

Article 12 The State shall establish a service system of traditional Chinese medicine covering urban and rural areas, and guarantee citizens' right to receive Chinese medicine services.

Thirteenth local people's governments at or above the county level shall rationally plan and allocate Chinese medicine service resources, and incorporate the construction of Chinese medicine medical institutions into the planning for the establishment of medical institutions in their respective administrative regions.

Article 14 The local people's governments at or above the county level and their relevant departments shall strengthen the capacity building of Chinese medicine services in medical institutions, set up Chinese medicine medical institutions of appropriate scale, set up Chinese medicine departments in general hospitals and qualified specialized hospitals run by the government, and set up Chinese medicine departments in community health service centers and township hospitals to ensure that community health service stations and village clinics can provide Chinese medicine services.

Article 15 The State encourages and supports social forces to set up medical institutions of traditional Chinese medicine. Medical institutions run by social forces in China enjoy the same rights as medical institutions run by the government in terms of access and practice.

Sixteenth the establishment of Chinese medicine medical institutions shall go through the relevant procedures in accordance with the Regulations on the Administration of Medical Institutions. However, Chinese medicine clinics that only provide Chinese medicine services can practice after being filed by the competent department of Chinese medicine of the local people's government at the county level. Measures for the filing, supervision and management of Chinese medicine clinics shall be formulated by the competent department of traditional Chinese medicine in the State Council.

Chinese medicine services referred to in this Law include Chinese medicine services such as syndrome differentiation and treatment, Chinese medicine treatment, Chinese medicine dispensing and Chinese medicine decoction, as well as non-drug therapies such as acupuncture, cupping and massage.

Seventeenth Chinese medical institutions organized by the government shall not be merged, revoked or changed at will; If it is really necessary to merge, cancel or change the medical nature of traditional Chinese medicine, it shall be approved by the competent department of traditional Chinese medicine of the people's government at the next higher level where the medical institution is held.

Eighteenth medical institutions to carry out traditional Chinese medicine services, should meet the basic requirements of traditional Chinese medicine services formulated by the competent department of traditional Chinese medicine in the State Council.

Nineteenth medical institutions of traditional Chinese medicine should be equipped with medical personnel, mainly providing Chinese medicine services; The application of modern scientific and technological methods should be conducive to maintaining and giving play to the characteristics and advantages of traditional Chinese medicine.

Twentieth community health service centers, township hospitals, community health service stations, village clinics should rationally allocate Chinese medicine technicians, and popularize and apply appropriate technologies of Chinese medicine.

The competent department of traditional Chinese medicine of the people's government at or above the county level shall establish a training base for the popularization of appropriate technology of traditional Chinese medicine with medical institutions with technical advantages of traditional Chinese medicine as the main support.

Twenty-first people's governments at or above the county level shall develop preventive health care services of traditional Chinese medicine and incorporate them into basic public health services.

Medical and health institutions should actively use Chinese medicine technology and methods to prevent and control diseases.

Article 22 People's governments at or above the county level shall give full play to the role of traditional Chinese medicine in the emergency work of public health emergencies, strengthen the reserve of emergency materials, equipment, facilities, technology and human resources of traditional Chinese medicine, and formulate emergency plans, including the use of traditional Chinese medicine technology to prevent and respond to public health emergencies.

The competent department of traditional Chinese medicine of the people's government at or above the provincial level may, according to the needs of responding to public health emergencies or controlling the epidemic situation of infectious diseases, issue technical plans for the prevention and control of traditional Chinese medicine. Medical and health institutions can take preparation measures such as mixing or decocting decoction according to the technical scheme of prevention and treatment of traditional Chinese medicine.

Article 23 The State implements classified management for medical personnel of traditional Chinese medicine. Chinese medicine personnel are divided into Chinese medicine and Chinese medicine.

The qualification and scope of practice of TCM doctors shall be implemented in accordance with the provisions of the Law of People's Republic of China (PRC) Municipality on Medical Practitioners.

Chinese medicine is only engaged in Chinese medicine services. Practitioners of traditional Chinese medicine shall be examined and registered by the competent department of traditional Chinese medicine of the people's government at the county level, and carry out relevant medical activities of traditional Chinese medicine within the registered geographical scope and practice scope. The specific measures shall be formulated by the competent department of traditional Chinese medicine in the State Council.

Twenty-fourth general practitioners should learn and use Chinese medicine technology to prevent and treat common diseases and frequently-occurring diseases.

Rural doctors should be able to use appropriate techniques of traditional Chinese medicine to prevent and treat common and frequently-occurring diseases.

Twenty-fifth Chinese medical advertisements shall be examined and approved by the competent departments of Chinese medicine of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government where the medical institutions are located. Without approval, advertisements of traditional Chinese medicine shall not be published.

Article 26 The State strengthens the construction of the standard system of traditional Chinese medicine, and clarifies the technical requirements of matters that need to be unified in the service of traditional Chinese medicine. The national standards and industrial standards of traditional Chinese medicine are formulated and published by the relevant departments of the State Council in accordance with the division of responsibilities, and the public can consult them free of charge.

Twenty-seventh people's governments at or above the county level shall strengthen the supervision and inspection of Chinese medicine services. The inspected entity shall cooperate with it and shall not refuse or obstruct it.

Chapter III Development of Traditional Chinese Medicine

Article 28 The State protects medicinal wildlife resources, conducts dynamic monitoring and regular investigation on medicinal wildlife resources, establishes a gene bank of medicinal wildlife resources, delineates nature reserves, encourages artificial cultivation and reproduction of medicinal wildlife, and supports the breeding of rare and endangered medicinal wildlife and related research.

Article 29 The State encourages the development of standardized cultivation and breeding of Chinese medicinal materials, supports the breeding of fine varieties of Chinese medicinal materials and improves the quality of Chinese medicinal materials.

Article 30 The State establishes an evaluation system for authentic Chinese herbal medicines, supports the breeding of authentic Chinese herbal medicines and improved varieties, supports the construction of authentic Chinese herbal medicine production bases, and encourages the adoption of measures such as the protection of geographical indication products to protect authentic Chinese herbal medicines.

Article 31 The collection, storage and primary processing of Chinese medicinal materials shall conform to the national drug standards.

Thirty-second rural doctors and Chinese medicine practitioners who plant, collect and use Chinese herbal medicines for their own use should have the knowledge and identification ability of Chinese herbal medicines.

Thirty-third the State Council traditional Chinese medicine departments regularly organize quality monitoring of Chinese herbal medicines, and publish the monitoring results to the public.

Article 34 The State protects the processing technology of traditional Chinese medicine decoction pieces, supports the production of traditional Chinese medicine decoction pieces and encourages the development of traditional Chinese medicine decoction pieces by using modern science and technology.

Article 35 Medical institutions may, according to clinical needs, process Chinese herbal pieces that are not available in the market and use them in their own institutions according to prescriptions issued by their own doctors. Medical institutions processing Chinese herbal pieces shall file with the pharmaceutical supervisory and administrative department of the local people's government at the county level.

Article 36 Medical institutions may, according to clinical needs, reprocess Chinese herbal pieces with prescriptions issued by their doctors.

Article 37 The State encourages the research and production of new Chinese medicine, and supports the research and development of safe and effective new Chinese medicine with independent intellectual property rights.

The state protects the processing technology and technology of traditional Chinese medicine, supports the production of traditional Chinese medicine, and encourages the application of modern science and technology to research and develop traditional Chinese medicine.

Article 38 The State encourages medical institutions to prepare and use traditional Chinese medicine preparations, and supports the preparation of traditional Chinese medicine preparations.

Thirty-ninth medical institutions to prepare traditional Chinese medicine preparations, should be in accordance with the provisions of the "drug administration law" of People's Republic of China (PRC), to obtain the "medical institutions preparation license". Medical institutions that have not obtained the Pharmaceutical Preparation License for Medical Institutions may entrust pharmaceutical production enterprises that have obtained the Pharmaceutical Production License or other medical institutions that have obtained the Pharmaceutical Preparation License for Medical Institutions to prepare traditional Chinese medicine preparations. Entrusted preparation of traditional Chinese medicine preparations shall be filed with the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the entrusting party is located.

The varieties of traditional Chinese medicine preparations prepared by medical institutions shall obtain the preparation approval number. However, only the varieties of traditional Chinese medicine preparations prepared by traditional techniques can be prepared after being filed by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.

Medical institutions are responsible for the quality of Chinese medicine preparations prepared by them; Where a traditional Chinese medicine preparation is entrusted, the entrusting party shall be responsible for the quality of the prepared traditional Chinese medicine preparation.

Article 40 The development, production, marketing and use of traditional Chinese medicines are not regulated in this Law, and the provisions of the Drug Administration Law of People's Republic of China (PRC) shall apply.

The pharmaceutical supervisory and administrative department shall strengthen the supervision and management of the development, production, management and use of traditional Chinese medicines.

Article 41 The State supports the international trade of traditional Chinese medicines and promotes the development of service trade. Where the import and export of medicinal wild animals and plants and their products are involved, the provisions of relevant laws and administrative regulations shall be observed.

Chapter IV Training of Talents

Article 42 The state develops Chinese medicine education and establishes a Chinese medicine education system with appropriate scale, reasonable structure and various forms to meet the needs of career development. Strengthen the training of general practitioners, specialists and basic Chinese medicine technicians in urban and rural areas, and encourage high-level education of integrated traditional Chinese and western medicine.

Article 43 Chinese medicine education should follow the growth law of Chinese medicine talents, focus on the content of Chinese medicine, pay attention to the theoretical education and clinical practice of Chinese medicine, pay attention to the combination of modern education methods and traditional education methods, and pay attention to embodying the culture with Chinese medicine characteristics.

Article 44 The State strengthens the education of Chinese medicine colleges and universities.

The training objectives, years of study, teaching forms, teaching contents and teaching evaluation of Chinese medicine colleges should reflect the characteristics of Chinese medicine and conform to its development law.

Chinese medicine education institutions and Chinese medicine professional setting standards, formulated by the competent department of education in the State Council in conjunction with the competent department of Chinese medicine in the State Council.

The establishment of a Chinese medicine education institution shall establish a clinical teaching base, and the standards for the establishment of the base shall be formulated by the competent education department of the State Council in conjunction with the competent Chinese medicine department of the State Council.

Article 45 The state develops the apprenticeship education of Chinese medicine practitioners, encourages Chinese medicine doctors and technicians to practice and engage in business activities with apprentices, teaches Chinese medicine theories and technical methods, and trains Chinese medicine technicians.

Article 46 The State develops continuing education of Chinese medicine.

The competent department of traditional Chinese medicine of the local people's government at or above the county level shall improve the continuing education network, formulate continuing education plans and organize continuing education. Strengthen the basic knowledge and skills training of Chinese medicine for urban and rural primary medical and health service personnel.

Technical personnel of traditional Chinese medicine should participate in continuing education in accordance with the regulations, and the institutions where they work should create conditions for them to receive continuing education.

Article 47 The state develops vocational education of traditional Chinese medicine.

The people's governments at or above the county level and their relevant departments shall take measures to support the development of vocational education of traditional Chinese medicine and cultivate practical talents.

Chapter V Inheritance, Innovation and Cultural Communication

Article 48 The state supports the inheritance and innovation of theories and technical methods of traditional Chinese medicine, encourages scientific research and academic contention of traditional Chinese medicine, and supports the development of academic schools.

The people's governments at or above the county level shall support the development of medical institutions or departments of traditional Chinese medicine with the characteristics and advantages of traditional Chinese medicine, and play its main role in the inheritance and innovation of traditional Chinese medicine.

Article 49 The State protects the traditional knowledge of traditional Chinese medicine. The obligee of TCM knowledge has the right of inheritance and use, and the right of informed consent and benefit sharing for others to acquire and use traditional knowledge. The specific measures shall be formulated by the intellectual property administrative department of the State Council in conjunction with the competent department of traditional Chinese medicine of the State Council.

Article 50 The state supports the inheritance of theories and technical methods of traditional Chinese medicine with important academic value. The competent department of traditional Chinese medicine of the people's government at or above the provincial level shall organize the selection of academic heritage projects and inheritors of traditional Chinese medicine within their respective administrative areas, and provide necessary conditions for them to carry out heritage activities.

Inheritors should carry out inheritance activities, train successors, summarize, collect and properly preserve relevant academic materials.

Fifty-first people's governments at or above the county level shall support the collation, research and utilization of ancient Chinese medicine literature, academic thoughts and diagnosis and treatment experience of famous and old Chinese medicine experts, and folk Chinese medicine diagnosis and treatment methods and technologies.

Encourage organizations and individuals to donate Chinese medicine literature, secret recipes, prescriptions, diagnosis and treatment methods and technologies with research and application value.

Fifty-second people's governments at or above the county level shall incorporate the scientific research of traditional Chinese medicine into the development plan of science and technology, and invest funds through various channels to strengthen and promote the scientific research of traditional Chinese medicine.

The state encourages cross-industry, cross-regional and interdisciplinary cooperation in scientific research of traditional Chinese medicine, and supports the integration of scientific and technological resources of traditional Chinese medicine, multi-disciplinary integration and Industry-University-Research integration.

Fifty-third scientific and technological innovation of traditional Chinese medicine should be guided by the theory of traditional Chinese medicine, with the improvement of clinical efficacy as the core, and pay attention to the application of modern science and technology.

Fifty-fourth people's governments at or above the county level shall improve the transformation mechanism of scientific and technological achievements of traditional Chinese medicine, take measures to encourage and support technology transfer and technology popularization, and improve the scientific and technological service system of traditional Chinese medicine.

Article 55 People's governments at or above the county level shall strengthen the publicity and knowledge popularization of Chinese medicine culture, establish multi-channel and multi-form platforms for spreading Chinese medicine culture and knowledge, and encourage organizations and individuals to create Chinese medicine culture and popular science works.

Fifty-sixth to carry out traditional Chinese medicine cultural propaganda and knowledge popularization activities, should abide by the relevant provisions of the state, adhere to the scientific spirit. No organization or individual may make false or exaggerated propaganda on Chinese medicine, and may not seek illegitimate interests in the name of Chinese medicine.

Fifty-seventh Chinese medicine books or other Chinese medicine publications, publishing units shall organize Chinese medicine technicians to examine and approve, and bear the publishing responsibility for the contents of the publications.

Radio, television, newspapers, Internet and other media should employ TCM technicians when promoting TCM health care knowledge.

Chapter VI Safeguard Measures

Fifty-eighth people's governments at or above the county level shall provide policy support and conditions for the development of traditional Chinese medicine and improve the management system of traditional Chinese medicine. The people's governments at or above the county level and their relevant departments shall encourage the provision and utilization of Chinese medicine services when formulating medical and health policies.

Article 59 The social insurance administrative department of the local people's government at or above the county level shall include qualified Chinese medical institutions into the scope of designated medical institutions for urban workers' basic medical insurance, urban residents' basic medical insurance and new rural cooperative medical care, and include qualified Chinese medical treatment items, Chinese herbal pieces, Chinese patent medicines and Chinese medicinal preparations into the scope of payment of the basic medical insurance fund.

The relevant departments of the State Council shall formulate the basic medical insurance payment policy and the basic drug policy, and should give full play to the advantages of Chinese medicine and support the provision of Chinese medicine services.

Article 60 Where the following matters are involved, a special organization for evaluation, evaluation and appraisal of traditional Chinese medicine shall be established or experts of traditional Chinese medicine shall participate in the evaluation, evaluation and appraisal:

(a) review and evaluation of Chinese medicine medical, health care, education and scientific research institutions;

(two) the quality evaluation of Chinese medical care services;

(three) qualification evaluation of professional and technical positions in traditional Chinese medicine;

(4) Evaluation of new technologies of traditional Chinese medicine;

(five) technical appraisal of medical damage in traditional Chinese medicine and evaluation of adverse reactions of traditional Chinese medicine;

(six) the establishment and evaluation of scientific research projects of traditional Chinese medicine;

(seven) the qualification evaluation of institutions, personnel and technology of traditional Chinese medicine and the identification of professional skills of traditional Chinese medicine;

(eight) other matters that need to be evaluated, evaluated and identified by experts in traditional Chinese medicine.

To carry out the above evaluation, review or appraisal activities, it should reflect the characteristics of traditional Chinese medicine and follow its own laws.

The qualification evaluation of professional and technical positions of traditional Chinese medicine and the identification of professional skills of traditional Chinese medicine should be based on the practical skills of traditional Chinese medicine.

Chapter VII Legal Liability

Article 61 If the competent department of traditional Chinese medicine and relevant departments of the people's government at or above the county level fail to perform their duties in accordance with the provisions of this Law, the people's government at the same level or the competent department of traditional Chinese medicine and relevant departments at a higher level shall order them to make corrections; If the circumstances are serious, the responsible leaders and persons directly responsible shall be punished according to law.

Sixty-second Chinese medicine clinics provide Chinese medicine services beyond the scope, and the competent department of Chinese medicine of the local people's government at the county level shall order it to make corrections and confiscate its illegal income; If the circumstances are serious, it shall be ordered to stop practicing.

The main person in charge and the directly responsible person in charge of a Chinese medicine clinic ordered to stop practicing shall not engage in the management of medical institutions within five years from the date of making the decision. If a medical institution employs personnel who are not allowed to engage in the management of medical institutions to engage in management work, the original license issuing department shall revoke the license or the original practice filing department shall order them to stop practicing.

Sixty-third Chinese medicine practitioners practice outside the registered geographical scope or carry out clinical activities outside the registered scope of practice, and the registered Chinese medicine authorities shall order them to suspend their practice activities for more than six months but less than one year; If the circumstances are serious, the registration certificate shall be revoked.

Article 64 Whoever, in violation of the provisions of Article 17 of this Law, merges, cancels or changes the medical nature of Chinese medicine institutions organized by the government without the approval of the competent department of Chinese medicine of the people's government at a higher level shall be ordered by the competent department of Chinese medicine of the people's government at a higher level to make corrections; If serious consequences are caused, the responsible leaders and persons directly responsible shall be punished according to law.

Chapter VIII Supplementary Provisions

Article 65 National autonomous areas may, in accordance with the Law of People's Republic of China (PRC) on Regional National Autonomy and the relevant provisions of this Law, formulate measures to promote the development of local Chinese medicine.

Article 66 This Law shall come into force on 1 month 1 day, 2004.