Order of the State Council of the People’s Republic of China (No. 374)
The Regulation of the People’s Republic of China on Traditional Chinese Medicines, which was adopted at the 3rd executive meeting of the State Council on April 2, 2003, is hereby
promulgated, and shall come into force on October 1, 2003.
Wen Jiabao, Premier
April 7, 2003
Regulation of the People’s Republic of China on Traditional Chinese Medicines
Chapter I General Provisions
Article 1 The present regulation is enacted with a view to inheriting and developing the traditional Chinese pharmacology, guaranteeing and promoting the development of the undertaking of traditional Chinese medicines, and protecting the health of human bodies.
Article 2 The entities or individuals engaging in the services of traditional Chinese medical treatment, prevention, care and recovery, the education, scientific research and foreign exchanges on traditional Chinese medicines, and in the administrative activities of the undertaking of traditional Chinese medicines inside the territory of the People’s Republic of China, shall abide by the present regulation.
The research and development, production, operation, use, supervision and administration of traditional Chinese medicines shall be in compliance with the Pharmaceutical Administration Law of the People’s Republic of China.
Article 3 The state protects, supports and develops the undertaking of traditional Chinese medicines, implements the guideline of stressing both traditional Chinese medicine and Western medicine, encourages the mutual study and supplements as well as the common improvement of traditional Chinese medicine and Western medicine, urges the organic combination of traditional Chinese medical science and Western medical science, and completely develops China’s undertaking of traditional Chinese medicines.
Article 4 For the development of the undertaking of traditional Chinese medicines, we shall comply with the principle of combining succession with innovations, maintain and carry forward the characteristics and advantages of traditional Chinese medicines, actively make use of modern science and technology, promote the development of the theories and practices of traditional Chinese medicines, and enhance the modernization of traditional Chinese medicines.
Article 5 The people’s governments at or above the county level shall include the undertaking of traditional Chinese medicines into the plans of national economic and social development, and harmonize the development of the undertaking of traditional Chinese medicines with the economy and society.
The local people’s government at or above the county level shall, when making the regional sanitation planning, arrange the overall establishment and distribution of medical institutions of traditional Chinese medicines as well as improve the network of urban and rural services of traditional Chinese medicines in light of the situation of social and economic development in this region and the residents’ needs in medical treatment.
Article 6 The administrative department for traditional Chinese medicines under the State Council shall be responsible for the administration of traditional Chinese medicines nationwide. The relevant departments under the State Council shall, within the scope of their respective duties, be responsible for the work related to traditional Chinese medicines.
The department for traditional Chinese medicines under the local people’s government at or above the county level shall be responsible for the administration of traditional Chinese medicines within its own administrative division. The relevant departments under the local people’s government at or above the county level shall, within the scope of their respective duties, be responsible for the work related to traditional Chinese medicines.
Article 7 The people’s governments at or above the county level shall grant awards to the entities and individuals who have made remarkable contributions to the succession and development of the undertaking of traditional Chinese medicines or have made prominent achievements in their work of traditional Chinese medicines in remote regions.
Chapter II Medical Institutions and Practitioners of Traditional Chinese Medicines
Article 8 Whoever intends to open a medical institution of traditional Chinese medicines shall meet the standards for setting up medical institutions of traditional Chinese medicines and the local regional sanitation planning, which are made by the administrative department of health under the State Council, and shall go through the formalities for approval in accordance with the Regulation on the Administration of Medical Institutions, but shall not engage in the activities of traditional Chinese medical treatment until having obtained the practicing permit of medical institution.
Article 9 The medical institutions of traditional Chinese medicines shall, when undertaking the activities of medical treatment service, bring the characteristics and advantages of traditional Chinese medicines into full play, follow the law of the development of traditional Chinese medicines, make full use of the functions of traditional Chinese medicines in prevention of diseases, health care and recovery, etc. by using traditional theories and methods and in combination with modern scientific and technological means, and provide the masses with services of traditional Chinese medicines at reasonable prices and good quality.
Article 10 Lawfully established urban or rural sanitary service institutions at the basic level such as community sanitary service centers (stations), town and township hospitals, etc., shall be able to provide services of traditional Chinese medical treatment.
Article 11 Practitioners of traditional Chinese medicines shall, in accordance with the relevant provisions in laws, administrative regulations and departmental rules on sanitary administration,
pass the qualification examination, and shall not engage in the service activities of traditional Chinese medicines until having been registered and having obtained the practicing certificate.
Those who have learned traditional Chinese medical science from masters and those who do specialize in this field shall, in accordance with the provisions of the administrative department of health under the State Council, pass the qualification assessment of practicing physicians or practicing assistant physicians, and shall not engage in the service activities of traditional Chinese medicines until having been registered and having obtained the practicing certificate.
Article 12 Practitioners of traditional Chinese medicines shall comply with the corresponding principles of diagnosis and treatment, standards of medical treatment techniques and technical operation rules on traditional Chinese medicines.
Generalist physicians and rural doctors shall have basic knowledge of traditional Chinese medicines, knowledge and techniques of using traditional Chinese medical science for diagnosis and treatment, and the basic skills in dealing with common diseases and frequently occurring diseases.
Article 13 A medical institution that intends to make an advertisement of traditional Chinese medical treatment shall, in accordance with the provisions, apply to and submit the relevant documents to the department responsible for the administration of traditional Chinese medicines under the people’s government of the province, autonomous region or municipality directly under the Central Government where it is located. The department responsible for the administration of traditional Chinese medicines under the people’s government of the province, autonomous region or municipality directly under the Central Government shall, within 10 working days as of the receipt of the relevant documents, examine them and make a decision on whether to issue the registered document of approval for advertising traditional Chinese medical treatment. To the medical institution meeting the prescribed requirements, the registered document of approval for advertising traditional Chinese medical treatment shall be issued. The medical institution failing to obtain the registered document of approval for advertising traditional Chinese medical treatment shall not make advertisements of traditional Chinese medical treatment.
The contents published in an advertisement of traditional Chinese medical treatment shall be consistent with those that have been examined and approved for publishing.
Chapter III Education and Scientific Research on Traditional Chinese Medicines
Article 14 The state takes measures to develop the undertaking of education on traditional Chinese medicines.
Various educational institutions of traditional Chinese medicines shall strengthen the teaching of basic theories of traditional Chinese medicines, stress the combination of the basic theories with the clinical practices of traditional Chinese medicines, and advance the quality education.
Article 15 Whoever intends to establish any of the various educational institutions of traditional
Chinese medicines shall meet the standards prescribed by the state for such establishment, and shall establish a clinical teaching base conforming to the standards prescribed by the state.
The standards for the establishment of educational institutions of traditional Chinese medicines shall be made by the administrative department of health under the State Council jointly with the administrative department of education under the State Council; the standards for clinical teaching bases of educational institutions of traditional Chinese medicines shall be made by the administrative department of health under the State Council.
Article 16 The state encourages the succession of academic experiences and technical specialties of traditional Chinese medicine experts, and educates senior clinical talents of traditional Chinese medical science and technical talents of traditional Chinese medicines.
Article 17 A tutor who undertakes the instruction of succession of academic experiences and technical specialties of traditional Chinese medicine experts shall meet the following conditions:
(a) having high academic level and rich practicing experiences, technical specialties and good occupational virtues;
(b) having worked in the field of traditional Chinese medicines for no less than 30 years and have held a senior professional post for no less than 10 years.
Article 18 A successor who is to succeed the academic experiences and technical specialties of traditional Chinese medicine experts shall meet the following conditions:
(a) having the academic qualification of regular course education or above in a higher educational institution and have good occupational virtues;
(b) being employed by a medical and sanitary institution or by an educational or scientific research institution of medical science to work in the field of traditional Chinese medicines, and to hold a professional post of intermediate level or above.
Article 19 The measures on the administration of the tutors and successors for the succession of academic experiences and technical specialties of traditional Chinese medicine experts shall be formulated by the administrative department for traditional Chinese medicines under the State Council jointly with other relevant departments.
Article 20 The department responsible for the administration of traditional Chinese medicines under the people’s government of the province, autonomous region or municipality directly under the Central Government shall, in accordance with the relevant provisions of the state, improve the system in its own region for the continuing education of persons in the field of traditional Chinese medicines, and make plans on training such persons.
The department responsible for the administration of traditional Chinese medicines under the local people’s government at or above the county level shall, upon the requirements of the planning on training persons in the field of traditional Chinese medicines, hold trainings of basic
knowledge and skills on traditional Chinese medicines for persons providing urban and rural sanitary services at the basic level.
A medical institution shall create conditions for the professionals of traditional Chinese medicines to accept the continuing education.
Article 21 The state develops the science and technology of traditional Chinese medicines, includes them into the scientific and technological development planning, and strengthens the construction of key scientific research institutions of traditional Chinese medicines.
The local people’s government at or above the county level shall make full use of the resources of traditional Chinese medicines, stress the scientific research and technical development of traditional Chinese medicines, take measures to develop, extend and apply technical achievements of traditional Chinese medicines, and promote the scientific and technological development of traditional Chinese medicines.
Article 22 For the scientific research of traditional Chinese medicines, it shall be stressed that both traditional and modern ways shall be used to carry out the basic theory research and clinical research of traditional Chinese medicines, and that traditional Chinese medical theories and modern science and technology shall be used to carry out the research on prevention and treatment of common diseases, frequently occurring diseases, as well as difficult and complicated diseases.
The scientific research institutions, higher educational institutions and medical institutions of traditional Chinese medicines shall make efforts at tackling the key problems in the scientific research of traditional Chinese medicines and extending and applying scientific and technological achievements of traditional Chinese medicines, and educate the academic leaders and middle-aged and young technical backbones of traditional Chinese medicines.
Article 23 Those who donate diagnostic and treatment methods of traditional Chinese medicines as well as literatures, esoteric recipes and proved recipes of traditional Chinese medicines, which are of great significance to the scientific and technological development of traditional Chinese medicines, shall be granted awards with reference to the Regulation on Scientific and Technological Awards of the State.
Article 24 The state supports the foreign exchange and cooperation in respect of traditional Chinese medicines, and enhances the international dissemination of traditional Chinese medicines.
The extension, transfer, foreign exchange of major scientific research achievements of traditional Chinese medicines, and the Chinese-foreign cooperative research of traditional Chinese medical technologies, shall be approved by the department responsible for the administration of traditional Chinese medicines under the people’s government at or above the provincial level, so as to prevent the loss of major traditional Chinese medical resources.
If any scientific research achievement of traditional Chinese medicines belongs to the scientific
and technological secrets of the state but is indeed necessary for transfer or foreign exchange, the provisions in laws, administrative regulations and departmental rules on maintenance of state secrets shall be abided by.
Chapter IV Guaranty Measures
Article 25 The local people’s government at or above the county level shall, in light of the needs in the development of the undertaking of traditional Chinese medicines and the situation of the local national economic and social development, gradually increase the input to the undertaking of traditional Chinese medicines, and shall support the development of the undertaking of traditional Chinese medicines.
No entity or individual shall misappropriate the expenses for the undertaking of traditional Chinese medicines for other use.
The state encourages domestic and overseas organizations and individuals to support the development of the undertaking of traditional Chinese medicines by means of donating or contributing investments, etc..
Article 26 Non-profit medical institutions of traditional Chinese medicines may, in accordance with the relevant provisions of the state, enjoy fiscal subsidies, tax reduction and exemption, and other preferential policies.
Article 27 The medical institutions designated and determined by the administrative department for labor security under the local people’s government at or above the county level to treat patients of urban and town employees enjoying basic medical insurances, shall include the qualified medical institutions of traditional Chinese medicines.
The medical institutions of traditional Chinese medicines qualified for the designation shall provide basic medical treatment services as prescribed to those who enjoy the insurances.
Article 28 The people’s governments at or above the county level shall take measures to strengthen the collection, neatening, research and protection of the literatures of traditional Chinese medicines.
The relevant entities and medical institutions of traditional Chinese medicines shall strengthen the management, protection and utilization of important literatures of traditional Chinese medicines.
Article 29 The state protects wild resources of traditional Chinese medicinal materials, supports the research, development and utilization of artificial substitutes of endangered animal and plant of traditional Chinese medicinal materials.
The local people’s government at or above the county level shall strengthen the reasonable development and utilization of traditional Chinese medicinal materials, encourage the establishment of bases for planting and cultivating traditional Chinese medicinal materials, and
promote the development and production of scarce traditional Chinese medicinal materials.
Article 30 The evaluating and appraising activities related to traditional Chinese medicines shall embody the characteristics of traditional Chinese medicines, and follow the development law of the traditional Chinese medicines.
For the purpose of appraising the qualification for holding the professional posts of traditional Chinese medicines, appraising and evaluating traditional Chinese medical treatment institutions, or educational or scientific research institutions of traditional Chinese medicines, initiating projects of or appraising achievements on scientific research topics of traditional Chinese medicines, a special appraising and evaluating organization of traditional Chinese medicines shall be established, or the experts of traditional Chinese medicines shall participate in the appraisal and evaluation.
Chapter V Legal Liabilities
Article 31 If any functionary in the department responsible for the administration of traditional Chinese medicines violates the present regulation in his administration of traditional Chinese medicines, by taking advantage of his post to accept the properties of others or to obtain other’s benefits, by abusing his power or neglecting his duty, or by failing to investigate the illegal acts he has found, and thus causing severe consequences, if a crime has been constituted, he shall be investigated for criminal liabilities in accordance with the law; if the consequences are not serious enough for criminal punishment, he shall be imposed upon the administrative sanction of demotion or dismission from his post in accordance with the law.
Article 32 If a medical institution of traditional Chinese medicines violates the present regulation and is under any of the following circumstances, it shall be ordered by the department responsible for the administration of traditional Chinese medicines under the local people’s government at or above the county level to make a correction within a time limit; if it fails to make a correction before the expiry of the time limit, it shall be ordered to cease its business for rectification, or its practicing permit of medical institution shall be revoked and its qualification as a medical institution designated to treat patients of urban and town employees enjoying basic medical insurances shall be cancelled by the original approving organ, and the liable persons in charge and other directly liable persons shall be imposed upon disciplinary sanctions in accordance with the law:
(a) it does not meet the standards for the establishment of medical institutions of traditional Chinese medicines;
(b) it has acquired the qualifications as a medical institution designated to treat patients of urban and town employees enjoying basic medical insurances, but fails to provide those who have bought insurances with basic medical treatment services as prescribed.
Article 33 Whoever, without authorization, opens a medical institution of traditional Chinese medicines without the approval or engages in the traditional Chinese medical treatment activities by failing to pass the examination for the qualification of practicing physician or practicing
assistant physician as prescribed to obtain the practicing permit, shall be punished in accordance with the relevant provisions in the Law of the People’s Republic of China on Practicing Physicians and the Regulation on the Administration of Medical Institutions.
Article 34 If an educational institution of traditional Chinese medicines violates the present regulation and is under any of the following circumstances, it shall be ordered by the department responsible for the administration of traditional Chinese medicines under the local people’s government at or above the county level to make a correction within a time limit; if it fails to make a correction before the expiry of the time limit, it shall be revoked by the original approving organ:
(a) it does not meet the prescribed standards for the establishment;
(b) it has not established a clinical teaching base conforming to the prescribed standards.
Article 35 Whoever violates the present regulation, and thus causing heavy losses to the resources of traditional Chinese medicines or divulging scientific and technological secrets of the state, and the case is severe, and a crime is constituted, he shall be investigated for criminal liabilities in accordance with the law; if the consequences are not serious enough for criminal punishment, he shall be ordered by the department responsible for the administration of traditional Chinese medicines under the local people’s government at or above the county level to make a correction, and the liable persons in charge and other directly liable persons shall be imposed upon disciplinary sanctions in accordance with the law.
Article 36 Whoever violates the present regulation by damaging or destroying the literatures of traditional Chinese medicines shall be ordered by the department responsible for the administration of traditional Chinese medicines under the local people’s government at or above the county level to make a correction, and the liable persons in charge and other directly liable persons shall be imposed upon disciplinary sanctions in accordance with the law; whoever damages or destroys the literatures of traditional Chinese medicines which belong to cultural relics under protection of the state, and the case is severe, and a crime is constituted, he shall be investigated for criminal liabilities in accordance with the law.
Article 37 If any medical institution of traditional Chinese medicines alters the approved contents in an advertisement of traditional Chinese medical treatment, its registered document of approval for advertisements shall be revoked by the original approving department, and its application for approval of advertisements shall not be accepted within 1 year.
The department responsible for the administration of traditional Chinese medicines shall, after revoking the registered document of approval for advertising traditional Chinese medical treatment, notify the supervisory and administrative organ for advertisements within 5 working days as of the date when it makes the decision on administrative disposal. The supervisory and administrative organ for advertisements shall, within 15 working days as of the receipt of the notification from the department responsible for the administration of traditional Chinese medicines, investigate and deal with the matter in accordance with the relevant provisions in the Advertising Law of the People’s Republic of China.
Chapter VI Supplementary Provisions
Article 38 The medical institutions of traditional Chinese medicines mentioned in the present regulation shall mean the hospitals and clinics of traditional Chinese medicines or those of traditional Chinese medicines in combination with Western medicines, which have obtained the practicing permit of medical institution in accordance with the law.
The administration of national minorities medicines shall be implemented with reference to the present regulation.
Article 39 The present regulation shall come into force on October 1, 2003.
中华人民共和国国务院令 （第374号）
《中华人民共和国中医药条例》已经2003年4月2日国务院第3次常务会议通过，现予公布，自2003年10月1日起施行。 总理 温家宝 2003年4月7日 中华人民共和国中医药条例
第一章 总则
第一条 为了继承和发展中医药学，保障和促进中医药事业的 发展，保护人体健康，制定本条例。
第二条 在中华人民共和国境内从事中医医疗、预防、保健、康复服务和中医药教育、科研、对外交流以及中医药事业管理活动的单位或者个人，应当遵守本条例。 中药的研制、生产、经营、使用和监督管理依照《中华人民共和国药品管理法》执行。
第三条 国家保护、扶持、发展中医药事业，实行中西医并重的方针，鼓励中西医相互学习、相互 补充、共同提高，推动中医、西医两种医学体系的有机结合，全面发展我国中医药事业。
第四条 发展中医药事业应当遵循继承与创新相结合的原则，保持和发扬中医药特色和优势，积极 利用现代科学技术，促进中医药理论和实践的发展，推进中医药现代化。
第五条 县级以上各级人民政府应当将中医药事业纳入国民经济和社会发展计划，使中医药事业与 经济、社会协调发展。 县级以上地方人民政府在制定区域卫生规划时，应当根据本地区社会、经济发展状况和居民医疗需求，统筹安排中医医疗机构的 设置和布局，完善城乡中医服务网络。
第六条 国务院中医药管理部门负责全国中医药管理工作。国务院有关部门在各自的职责范围内负责与中医药有关的工作。 县级以上地方人民政府负责中医药管 理的部门负责本行政区域内的中医药管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与中医药有关的工作。
第七条 对在继承和发展中医药事业中做出显著贡献和在边远地 区从事中医药工作做出突出成绩的单位和个人，县级以上各级人民政府应当给予奖励。
第二章 中医医疗机构与从业人员
第八条 开办中医医疗机构，应当符合国务院卫生行政部门制定的中医医疗机构设置标准和当地区 域卫生规划，并按照《医疗机构管理条例》的规定办理审批手续，取得医疗机构执业许可证后，方可从事中医医疗活动。
第九条 中医医疗机构从事医疗服务活动，应当充分发挥中医药 特色和优势，遵循中医药自身发展规律，运用传统理论和方法，结合现代科学技术手段，发挥中医药在防治疾病、保健、康复中的作用，为群众提供价格合理、质量 优良的中医药服务。
第十条 依法设立的社区卫生服务中心(站)、乡镇卫生院等城乡基层卫生服务机构，应当能够提供中医医疗服务。
第十一条 中医从业人员，应当依照有关卫生管理的法律、行政法规、部门规章的规定通过资格 考试，并经注册取得执业证书后，方可从事中医服务活动。 以师承方式学习中医学的人员以及确有专长的人员，应当按照国务院卫生行政部门的规定， 通过执业医师或者执业助理医师资格考核考试，并经注册取得医师执业证书后，方可从事中医医疗活动。
第十二条 中医从业人员应当遵守相应的中医诊断治疗原则、医疗技术标准和技术操作规范。 全科医师和乡村医生应当具备中医药基本知识以及运用中医诊疗知识、技术，处理常见病和多发病的基本技能。
第十三条 发布中医医疗广告，医疗机构应当按照规定向所在 地省、自治区、直辖市人民政府负责中医药管理的部门申请并报送有关材料。省、自治区、直辖市人民政府负责中医药管理的部门应当自收到有关材料之日起10个 工作日内进行审查，并作出是否核发中医医疗广告批准文号的决定。对符合规定要求的，发给中医医疗广告批准文号。未取得中医医疗广告批准文号的，不得发布中 医医疗广告。 发布的中医医疗广告，其内容应当与审查批准发布的内容一致。
第三章 中医药教育与科研
第十四条 国家采取措施发展中医药教育事业。 各类中医药教育机构应当加强中医药 基础理论教学，重视中医药基础理论与中医药临床实践相结合，推进素质教育。
第十五条 设立各类中医药教育机构，应当符合国家规定的设置标准，并建立符合国家规定标准的 临床教学基地。 中医药教育机构的设置标准，由国务院卫生行政部门会同国务院教育行政部门制定；中医药教育机构临床教学基地标准，由国务院卫生 行政部门制定。
第十六条 国 家鼓励开展中医药专家学术经验和技术专长继承工作，培养高层次的中医临床人才和中药技术人才。
第十七条 承担中医药专家学术经验和技术专长继承工作的指导老师应当具备下列条件： (一)具有较高学术水平和丰富的实践经验、技术专长和良好的职业品德； (二)从事中医药专业工作30年以上并担任高级专业技术职务10年以 上。
第十八条 中医药专家学 术经验和技术专长继承工作的继承人应当具备下列条件： (一)具有大学本科以上学历和良好的职业品德； (二)受聘于医疗卫生机构或 者医学教育、科研机构从事中医药工作，并担任中级以上专业技术职务。
第十九条 中医药专家学术经验和技术专长继承工作的指导老师以及继承人的管理办法，由国务院 中医药管理部门会同有关部门制定。
第二十条 省、自治区、直辖市人民政府负责中医药管理的部门应当依据国家有关规定，完善本地区中医药人员继续教育制度，制定中医药人员培训规划。 县级以 上地方人民政府负责中医药管理的部门应当按照中医药人员培训规划的要求，对城乡基层卫生服务人员进行中医药基本知识和基本技能的培训。 医疗机 构应当为中医药技术人员接受继续教育创造条件。
第二 十一条 国家发展中医药科学技术，将其纳入科学技术发展规划，加强重点中医药科研机构建设。