Order of the  President of the People's Republic of China

(No. 59)

The Law of the People's  Republic 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.