Law of China on Traditional Chinese Medicine

· Document Number：Order No. 59 of the President

· Area of Law： Health and Sanitation

· Level of Authority： Laws

· Date issued：12-25-2016

· Effective Date：07-01-2017

· Status： Effective

· Issuing Authority： Standing Committee of the National People's Congress

Order of the President of China
(No. 59)
Law of China on Traditional Chinese Medicine, as adopted at the 25th Session of the Standing Committee of the Twelfth National People's Congress of the People's Republic of China on December 25, 2016, is hereby issued and shall come into force on July 1, 2017.
President of the People's Republic of China: Xi Jinping
December 25, 2016
Law of the People's Republic of China on Traditional Chinese Medicine
(Adopted at the 25th Session of the Standing Committee of the Twelfth National People's Congress of the People's Republic of China on December 25, 2016)
Table of Content
Chapter I General Provisions
Chapter II Traditional Chinese Medicine Services
Chapter III Traditional Chinese Medicine Protection and Development
Chapter IV Cultivation of Traditional Chinese Medicine Talents
Chapter V Traditional Chinese Medicine Scientific Research
Chapter VI Traditional Chinese Medicine Inheritance and Cultural Transmission
Chapter VII Guarantee Measures
Chapter VIII Legal Liability
Chapter IX Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is developed for purposes of inheriting and carrying forward traditional Chinese medicine, guaranteeing and promoting the development of the traditional Chinese medicine undertaking, and protecting the health of the people.
Article 2 For the purpose of this Law, “traditional Chinese medicine” (TCM) is the general term of medicine of all Chinese ethnic groups including the Han ethnic group and minority ethnic groups, reflects the understanding of the Chinese nation on life, health and diseases, and is a medicine and pharmacology system with long historical traditions and unique theories and technical methods.
Article 3 The TCM undertaking is an important part of the medicine and health undertaking of the state. The state shall vigorously develop the TCM undertaking, carry out the principle of giving equal emphasis to TCM and western medicine, establish the management rules in compliance with TCM features, and maximize the role of TCM in the medicine and health undertaking of the state.
In the development of the TCM undertaking, the TCM development rule shall be observed, the integration of inheritance and innovation shall be adhered to, TCM features and advantages shall be maintained and maximized, and modern scientific technologies shall be utilized, so as to promote the development of TCM theories and practice.
The state shall encourage the mutual learning from each other between, mutual supplementation, and coordinated development of TCM and western medicine, maximize their advantages, and promote the integration of TCM and western medicine.
Article 4 The people's government at or above the county level shall include TCM undertaking in the national economic and social development plan, establish and improve the TCM management system, and make overall planning on and promote the development of the TCM undertaking.
Article 5 The competent TCM department of the State Council shall take charge of TCM administration nationwide. Other relevant departments of the State Council shall take charge of TCM administration within the scope of their respective functions.
The competent TCM department of the local people's government at or above the county level shall take charge of TCM administration within its administrative region. Other relevant departments of the local people's government at or above the county level shall be responsible for the work relating to TCM administration within the scope of their respective functions.
Article 6 The state shall strengthen the building of a TCM service system, make rational planning on and allocate TCM service resources, and provide guarantee for citizens' obtainment of TCM services.
The state encourages social forces to invest in the TCM undertaking and gives supports to them, and encourages organizations and individuals to make donation for and support the TCM undertaking and gives supports to them.
Article 7 The state shall develop TCM education, establish a TCM education system which satisfies the requirements for the development of the TCM undertaking and has a proper scale, rational structure, and diversified forms to cultivate TCM talents.
Article 8 The state supports TCM scientific research and technical development, encourages innovation in TCM science and technologies, shall popularize and apply TCM scientific and technological achievements, protect TCM intellectual property rights, and enhance TCM scientific and technical level.
Article 9 The state shall support TCM foreign exchange and cooperation, and promote international transmission and application of TCM.
Article 10 The organizations and individuals that have made prominent contributions to the TCM undertaking shall be commended and rewarded in accordance with the relevant provisions of the state.
Chapter II TCM Services
Article 11 The people's government at or above the county level shall include the construction of TCM medical institutions in the plan on the setup of medical institutions, launch TCM medical institutions with proper scale, and support the development of medical institutions with TCM features and advantages.
To merge or cancel a TCM medical institution launched by the government or change the nature as a TCM medical institution, the opinion of the competent TCM department of the people's government at the next higher level shall be solicited.
Article 12 Comprehensive hospitals and maternity and child care institutions launched by governments as well as qualified specialized hospitals, community health service centers and township health centers shall set TCM departments and clinics.
Local people's governments at or above the county level shall take measures to enhance the capability of community health service stations and village clinics in the provision of TCM services.
Article 13 The state supports social forces in their launching TCM medical institutions.
TCM medical institutions launched by social forces shall enjoy equal rights in such aspects as access, practice, basic medical insurance, scientific research and teaching, and the assessment of title of medical personnel with TCM medical institutions launched by governments.
Article 14 To launch a TCM medical institution, approval formalities shall be undergone according to the provisions of the state on the administration of medical institutions, and the provisions on the administration of medical institutions shall be observed.
A TCM clinic launched may conduct practice activities after the name, address, treatment scope and staffing of the clinic, and other information are reported to the competent TCM department of the local county people's government for recordation. The TCM clinic shall publicize the clinic's treatment scope, the name and practice scope of the TCM physicians in a conspicuous position of the clinic, and shall not conduct medical activities beyond the scope granted recordation. The specific measures shall be drafted by the competent TCM department of the State Council, and be reported to the health administrative department of the State Council for examination and issuance.
Article 15 A person who conducts TCM medical activities shall, in accordance with the provisions of the Law of the People's Republic of China on Practicing Physicians, obtain the qualification as a TCM physician through the TCM physician qualification test, and conduct practice registration. The content of the TCM physician qualification test shall reflect TCM features.
A person who learns TCM through a teacher or indeed has specialty in medical skills through many years of practice shall be recommended by at least two TCM physicians, and may be qualified as a TCM physician after passing the examination of practice skills and effects organized by the competent TCM department of the people's government of the province, autonomous region or municipality directly under the Central Government, and after he or she conducts practice registration according to the examination content, he or she may conduct TCM medical activities in the form of conducting individual business operation or working in medical institutions within the registered scope of practice. The competent TCM department of the State Council shall draft the measures for the categorized examination of personnel prescribed in this paragraph according to the safety risks of TCM technical methods, and report the measures to the health administrative department of the State Council for examination and issuance.
Article 16 A TCM medical institution shall mainly assign professional TCM personnel as medical personnel to mainly provide TCM services. TCM physicians who have obtained the physician qualification upon examination may, according to the relevant provisions of the state, adopt modern scientific and technical methods relating to their specialties in practice activities after receiving training and passing the examination. The modern scientific and technical methods adopted in medical activities shall be conductive to maintaining and enhancing TCM features and advantages.
Community health service centers, township health centers, community health service stations and qualified village clinics shall rationally assign professional TCM technicians, and utilize and popularize appropriate TCM technical methods.
Article 17 TCM services shall be provided by taking TCM theories as the guidance, apply TCM technical methods, and comply with the basic requirements for TCM services determined by the competent TCM department of the State Council.
Article 18 The people's government at or above the county level shall develop TCM prevention and health care services, and include them in basic public health service items for overall planning and implementation according to the relevant provisions of the state.
The people's government at or above the county level shall bring into play the role of TCM in emergency response to public health incidents, and strengthen the reserves of TCM emergency response materials, equipment, facilities, technologies and talents.
Medical and health institutions shall actively utilize TCM theories and technical methods in disease prevention and control.
Article 19 A medical institution that plans to release a TCM medical advertisement shall be subject to the examination and approval of the competent TCM department of the people's government of the province, autonomous region or municipality directly under the Central Government; and shall not issue the advertisement without examination and approval. The content of the issued TCM medical advertisement shall be consistent with the content approved upon examination, and comply with the relevant provisions of the Advertising Law of the People's Republic of China.
Article 20 The competent TCM department of the people's government at or above the county level shall strengthen the supervision and inspection of TCM services, and take the following matters as the focus of supervision and inspection:
(1) Whether the TCM medical institution or TCM physician conducts medical activities beyond the prescribed scope.
(2) Whether the provision of TCM services complies with the basic requirements for TCM services determined by the competent TCM department of the State Council.
(3) Whether the release of TCM medical advertisements complies with the provisions of this Law.
The competent TCM department shall conduct supervision and inspection in accordance with the law, and relevant institutions and individuals shall cooperate and shall not refuse to accept or obstruct the supervision and inspection.
Chapter III TCM Protection and Development
Article 21 The state shall develop technical rules and standards on TCM material planting and breeding, collection, storage and primary processing, strengthen quality supervision and administration of the entire process of TCM production and circulation, and guarantee TCM quality safety.
Article 22 The state shall encourage the development of standardized TCM material planting and breeding, strictly administer the use of pesticides, fertilizers and other agricultural inputs, prohibit the use of highly toxic and toxic pesticides in TCM material planting, support the cultivation of improved TCM material varieties, and enhance TCM material quality.
Article 23 The state shall establish a genuine regional TCM material evaluation system, support the cultivation of genuine regional TCM material varieties, support the construction of genuine regional TCM material production bases, strengthen the ecological environmental protection of genuine regional TCM material production bases, and encourage the adoption of geographical indication product protection and other measures to protect genuine regional TCM materials.
“Genuine regional TCM material” as mentioned in the preceding paragraph means TCM materials which are selected by TCM physicians in long-term clinic application, produced in specific regions, and have better quality and treatment effects, more stable quality and higher degree of popularity in comparison with the same kind of TCM materials produced in other regions.
Article 24 The drug administrative department of the State Council shall organize and strengthen the monitoring of TCM material quality, and release the monitoring result to the public on a periodical basis. Relevant departments of the State Council shall offer assistance in effectively conducting the work relating to the monitoring of TCM material quality.
The collection and storage of TCM materials and primary processing of TCM materials shall comply with the relevant technical rules, standards and administrative provisions of the state.
The state shall encourage the development of a modern TCM material circulation system, enhance the technical level of TCM material and storage, among others, and establish a traceable TCM material circulation system. Drug production enterprises that purchase TCM materials shall establish a check record system for purchased goods. TCM materials dealers shall establish check record systems for purchased goods, and indicate the places of production of TCM materials.
Article 25 The state shall protect wild fauna and flora resources for drug use, conduct dynamic monitoring and regular inspection of wild fauna and flora resources for drug use, establish the genetic database of wild fauna and flora resources, encourage the development of genetic database of wild fauna and flora resources for drug use, encourage the development of artificial planting and breeding, and support the legal protection and cultivation of precious and endangering wild fauna and flora for drug use and relevant research thereof.
Article 26 TCM physicians who practice in village medical institutions and village doctors who have TCM knowledge and recognition capability may grow and pick genuine regional TCM by themselves and use them in practice activities according to the relevant provisions of the state.
Article 27 The state shall protect the traditional technologies and techniques for making small pieces of ready-for-use TCM, support the application of traditional techniques in making small pieces of ready-for-use TCM, and encourage the application of modern scientific technologies to conduct technical research for making small pieces of ready-for-use TCM.
Article 28 For small pieces of ready-for-use TCM not supplied on the market, a medical institution may make and use them within its institution according to the requirements of prescription of physicians of the medical institution. The medical institution shall abide by the provisions on making small pieces of ready-for-use TCM, be responsible for the quality of small pieces of ready-for-use TCM made by it, and guarantee the safety of drugs. A medical institution that makes small pieces of ready-for-use TCM shall report to the drug administrative department of the local people's government at the level of a districted city for recordation.
According to the requirements for clinic drug use, a medical institution may reprocess small pieces of ready-for-use TCM based on the prescription of physicians of the medical institution.
Article 29 The state encourages and supports the research and production of new TCM.
The state shall protect traditional TCM processing technologies and techniques, support the production of Chinese patent drugs of traditional preparation, and encourage the use of modern scientific and technological research to develop Chinese patent drugs of traditional preparation.
Article 30 In the production of compound TCM preparations originating from famous ancient prescriptions and meeting the conditions prescribed by the state, when an application for the drug approval document number is filed, only non-clinic safety research materials may be provided. The specific administrative measures shall be developed by the drug administrative department together with the competent TCM department of the State Council.
“Famous ancient prescriptions” as mentioned in the preceding paragraph mean the prescriptions recorded in ancient TCM books which are still widely applied nowadays, have definite treatment effects, and have distinctive features and advantages. The specific catalogue shall be developed by the competent TCM department together with the drug administrative department of the State Council.
Article 31 The state encourages medical institutions to make and use TCM preparations according to their requirements for using drugs for clinic use, supports the application of traditional techniques in preparing TCM preparations, and supports the research and development of new TCM based on TCM preparations.
A medical institution that makes TCM preparations shall obtain the preparation license of medical institutions according to the Drug Administration Law of the People's Republic of China, or entrust a drug production enterprise which has obtained the drug production license or any other medical institution that has obtained the preparation license of medical institutions with the making of TCM preparations. For the entrustment of TCM preparations, recordation formalities shall be undergone at the drug administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government at the place where the entrusting party is located.
The medical institution shall be responsible for the quality of TCM preparations made by it, and if it entrusts the making of TCM preparations, the entrusting party and the entrusted party shall assume the corresponding liability respectively for the quality of TCM preparations made.
Article 32 The approval document number of preparations shall be obtained in accordance with the law for the varieties of TCM preparations made by medical institutions. However, the varieties of TCM preparations made merely by applying traditional techniques may be made after recordation formalities are undergone at the drug administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government at the place where the medical institution is located, and no preparation approval document number is required.
The medical institution shall strengthen the monitoring of adverse reactions of varieties of TCM preparations granted recordation, and make reports according to relevant provisions of the state. The drug administrative department shall strengthen the supervision and inspection of the preparation and use of varieties of TCM preparations granted recordation.
Chapter IV Cultivation of TCM Talents
Article 33 TCM education shall observe the law of growth of TCM talents, focus on TCM content, reflect the features of TCM culture, and pay attention to the integration of classic TCM theories and TCM clinic practice, modern education methods and traditional education methods.
Article 34 The state shall improve the TCM school education system, and support the development of institutions of higher learning, intermediary vocational schools and other educational institutions which specially provide TCM education.
The cultivation objectives, years of schooling, education forms, teaching content, and standards for teaching evaluation and evaluation of academic level, among others, of TCM school education shall reflect the features of TCM specialties, and comply with the development law of TCM specialties.
Article 35 The state shall develop TCM inheritance and education, support TCM physicians and professional TCM technicians with rich clinical experience and technical specialty to teach students in practice and business activities, teach TCM theories and technical methods, and cultivate professional TCM technicians.
Article 36 The state shall strengthen the cultivation and training of TCM physicians and grassroots professional TCM technicians in urban and rural areas.
The state shall develop the education on the integration of TCM and western medicine, and cultivate high-level TCM and western medicine integration talents.
Article 37 The competent TCM department of the local people's government at or above the county level shall organize TCM continuing education, and provide more training on basic TCM knowledge and skills to medical personnel, especially grassroots medical physicians in urban and rural areas.
Professional TCM technicians shall participate in continuing education as required, and the institutions where they work shall create conditions for them to receive continuing education.
Chapter V TCM Scientific Research
Article 38 The state encourages scientific research institutions, institutions of higher learning, medical institutions, and drug production enterprises, among others, to adopt modern scientific technologies and traditional TCM research methods to conduct TCM scientific research, strengthen the research on the integration of TCM and western medicine, and promote the inheritance and innovation of TCM theories and technical methods.
Article 39 The state shall take measures to support the review, research and utilization of academic thoughts and treatment experiences of ancient TCM documents and famous TCM experts as well as folk TCM technical methods.
The state encourages organizations and individuals to donate TCM documents, secret prescriptions, proved prescriptions, treatment methods and technologies with the value of scientific research and clinic application.
Article 40 The state shall establish and improve the scientific and technological innovation system, evaluation system and management mechanism commensurate with TCM features, and promote TCM scientific and technological progress and innovation.
Article 41 The state shall take measures to strengthen TCM basic theories and treatment methods based on syndrome differentiation, strengthen the TCM prevention and treatment of common diseases, frequently-occurring diseases, major refractory diseases and major infectious diseases, and the scientific research of other projects which play the major role of promoting the development of TCM theories and practice.
Chapter VI TCM Inheritance and Cultural Transmission
Article 42 With respect to TCM theories and technical methods with important academic value, the competent TCM department of the people's government at or above the provincial level shall organize the selection of TCM academic inheritance projects and inheritors within its administrative region, and provide necessary conditions for inheritance activities. The inheritors shall conduct inheritance activities, cultivate successors, and collect, review and appropriately preserve relevant academic materials. If they fall under representative items of intangible culture heritage, inheritance activities shall be conducted in accordance with the relevant provisions of the Intangible Cultural Heritage Law of the People's Republic of China.
Article 43 The state shall establish a TCM traditional knowledge protection database, protection catalogue and protection rules.
The right-holders of TCM traditional knowledge shall enjoy the rights to inherit and use TCM traditional knowledge held by them, and enjoy the rights such as informed consent and interest sharing of TCM traditional knowledge.
The state shall offer particular protection to the composition and production techniques of traditional TCM prescriptions falling under state secrets as legally recognized by the state.
Article 44 The state shall develop TCM health care services and support social forces in launching standardized TCM health care institutions. TCM health care service rules and standards shall be developed by the competent TCM department of the State Council.
Article 45 The people's government at or above the county level shall strengthen the publicity of TCM culture, popularize TCM knowledge, and encourage organizations and individuals to create TCM culture and science popularization works.
Article 46 TCM cultural publicity and knowledge publicity activities shall be conducted in accordance with the relevant provisions of the state. No organization or individual may make fraudulent or exaggerated publicity of TCM or seek illicit benefits in the name of TCM.
Radio, television, newspapers and journals, Internet and other media shall retain professional TCM technicians to publicize TCM knowledge.
Chapter VII Guarantee Measures
Article 47 The people's government at or above the county level shall provide policy support and guarantee conditions for the development of the TCM undertaking, and include the funds for the development of the TCM undertaking in the fiscal budget at the same level.
Where the people's government at or above the county level and its relevant departments develop basic medical insurance payment policies, drug policies and other medicine and health policies, the competent TCM department shall participate, pay attention to maximizing the advantages of TCM, and support the provision and utilization of TCM services.
Article 48 The people's government at or above the county level and its relevant departments shall, according to the statutory price management authority, rationally determine the charging items and standards of TCM medical services, reflecting the cost of TCM medical services and value of professional technologies.
Article 49 Relevant departments of the local people's government at or above the county level shall, according to the provisions of the state, include qualified TCM medical institutions in the scope of designated medical institutions covered by basic medical insurance, and include qualified TCM treatment items, small pieces of ready-for-use TCM, Chinese patent drugs and TCM preparations of medical institutions in the scope of payment of basic medical insurance funds.
Article 50 The state shall strengthen the construction of the TCM standard system, and formulate standards and revise in a timely manner the technical requirements that shall be unified according to TCM features.
TCM national standards and industry standards shall be developed or revised by the relevant departments of the State Council according their functions, and be released on their websites for the free reference of the public.
The state shall promote the establishment of an international TCM standard system.
Article 51 To conduct review, appraisal or identification activities relating to TCM as prescribed by laws and administrative regulations, a special organization for TCM review, appraisal and identification shall be formed, or TCM experts shall participate in it.
Article 52 The state shall take measures to provide more support to the medicine inheritance and innovation, application and development and talent cultivation of minority ethnic groups, strengthen the building of medical institutions and physicians of minority ethnic groups, and promote and regulate the development of the medicine undertaking of minority ethnic groups.
Chapter VIII Legal Liability
Article 53 Where the competent TCM department of the people's government at or above the county level or any other relevant department fails to perform the functions prescribed in this Law, the people's government at the same level or the relevant department of the people's government at a higher level shall order the violator to take corrective action; and if the circumstances are serious, shall take disciplinary actions against the directly responsible person in charge and other directly liable persons in accordance with the law.
Article 54 Where a TCM clinic conducts medical activities beyond the scope granted recordation in violation of the provisions of this Law, the competent TCM department of the local county people's government shall order the clinic to take corrective action, confiscate its illegal income, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on it; and if the circumstances are serious, shall order it to cease practice activities.
Where the TCM clinic is ordered to cease practice activities, its directly responsible person in charge shall not conduct administration within a medical institution within five years as of the date when the penalty decision is made. If a medical institution retains any of the aforesaid persons, who is prohibited from administration, to conduct administration, the original license issuer shall revoke the practice license or the original department granting its recordation shall order it to cease practice activities.
Article 55 Where a TCM physician who is qualified as a physician upon examination conducts medical activities beyond the registered scope of practice in violation of the provisions of this Law, the competent TCM department of the people's government at or above the county level shall order him or her to suspend practice activities for not less than six months but not more than one year, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on him or her, and if the circumstances are serious, shall revoke his or her practice license.
Article 56 In the case of failing to undergo recordation formalities in launching a TCM clinic, making small pieces of ready-for-use TCM, or entrusting the making of TCM preparations, or in the case of providing any false materials at the time of recordation, the competent TCM department and the drug administrative department shall order the violator to take corrective action according to their respective functions, confiscate the illegal income, impose a fine of not more than 30,000 yuan, and announce the relevant information to the public; and if the violator refuses to take corrective action, shall order the violator to cease practice activities or order the violator to cease the making of small pieces of ready-for-use TCM or entrusted making of TCM preparations, and its directly responsible persons shall not conduct TCM-related activities within five years.
A medical institution that fails to conduct recordation in accordance with the provisions of this Law in making TCM preparations by applying traditional techniques, or fails to make TCM preparations according to the requirements indicated in recordation materials shall be punished as producing fake drugs.
Article 57 Where the content of an issued TCM medical advertisement is inconsistent with the content approved upon examination in violation of the provisions of this Law, the original examination department shall revoke the examination approval document of the advertisement, and shall not accept the application for examining the advertisement of the medical institution within one year.
A violator that commits any violation of law in the release of TCM medical advertisements other than those prescribed in the preceding paragraph in violation of the provisions of this Law shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China.
Article 58 Where anyone uses any highly toxic or toxic pesticide in TCM planting in violation of the provisions of this Law, the violator shall be punished in accordance with the provisions of relevant laws and regulations; and if the circumstances are serious, the public security authority may detain its directly responsible person in charge and other directly liable persons for not less than five days but not more than 15 days.
Article 59 Anyone that causes any personal or property damage in violation of the provisions of this Law shall assume civil liability in accordance with the law; and shall be subject to criminal liability in accordance with the law if any crime is constituted.
Chapter IX Supplementary Provisions
Article 60 The provisions of the Law of the People's Republic of China on Practicing Physicians, the Drug Administration Law of the People's Republic of China and other relevant laws and administrative regulations shall apply to TCM administration in the absence of provisions in this Law.
Competent health departments of armies shall organize TCM administration of armies in accordance with this Law and relevant provisions of armies.
Article 61 Autonomous regions may, in accordance with the relevant provisions of the Law of the People's Republic of China on Regional National Autonomy and this Law, and in light of actual circumstances, develop measures for promoting and regulating the development of medical and drug undertaking of minority ethnic groups of their areas.
Article 62 Blind personnel who are qualified as blind medical massage personnel in accordance with the relevant provisions of the state may provide medical massage services in the form of individual business operation or working in medical institutions.
Article 63 This Law shall come into force on July 1, 2017.