Adopted at the 25th Session of the Standing Committee of the Twelfth National People’s Republic of China on December 25th, 2016, the publication of Law of the People’s Republic of China on Traditional Chinese Medicine Legally ensures the development of Chinese medicine Chinese, and boosts morale of overseas TCM practitioners. The Law provides a useful reference for TCM administration and development by the government of other countries and regions, with a significant impact on the TCM development all over the world.
In order to have all the member groups. Relevant organizations and the vast majority of TCM practitioners involving in activities organized by World Federation of Chinese Medicine Societies (hereafter shorted as WFCMS) easily acquire the Law and accurately understand the content, the WFCMS International Standardization Department organized the translation work and Specialty Committee of Translation of WFCMS, Working Committee of Promoting the Regulation of Chinese Medicine of WFCMS and the WFCMS International Liaison Department participated in and gave great support. Experts and member groups from Australia, Brazil, Canada, Spain, the United States and other countries and professors in universities in China, actively involved in the review and editing of the translation. Zhang Ke, the editor of People’s Medical Publishing House, gave great support to our work when he knew the publication plan. The enthusiasm and selfless dedication of these experts and scholars towards TCM undertaking moved us a lot.
By interpreting the original content and meanings as accurately a possible, this English translation version fully took foreign language readers’ expression way into consideration. Though WFCMS has much experience in TCM translation and tried to translate as accurate as possible, mistakes and omissions can hardly be avoided. Please feel free to contact us for further discussion.
Statement: This translation version by WFCMS has no legal validity, simply for reference. The copyright of this translation is reserved by WFCMS and please give credit to the original author when you use it elsewhere. WFCMS reserves all the rights for final interpretation.
Law of People’s Republic of China on Traditional Chinese Medicine….1
Notes for Several Terms……………………………………………………2
(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 25th, 2016)
Chapter I General Provisions……..
Chapter II TCM Services……..
Chapter III Protection and Development of TCM
Chapter 4 Education and Training of Traditional Chinese Medicine
Chapter 5 Scientific Research of TCM
Chapter 6 Inheritance and Cultural Communication of TCM
Chapter 7 Safeguard Measures
Chapter 8 Legal Liability
Chapter 9 Supplementary Provisions
Chapter I General Provisions
The law is enacted for the purpose of inher- iting and carrying forward traditional Chinese medicine, ensuring and promoting the development of traditional Chi- nese medicine for the health of the people.
Traditional Chinese medicine ( hereafter referred to as TCM ) in this law is a general term for the medicine of all ethnic groups including the Han nationality and ethnic minorities in China. It is a medical and pharmacological science system that reflects Chinese people's understanding of life, health and disease, with a long history and unique theories and techniques.
TCM undertaking is an important part of medicine and healthcare fields in China. The state shall vigorously develop TCM undertaking, carrying out the principle of balance between Chinese and Western medicine, establishing an administrative system that conforms to TCM features and giving TCM full play in the medical and healthcare affairs in China.
In the development of the TCM undertaking, the core value and laws of TCM development shall be followed, the integration of inheritances and innovation adhered to, TCM features and advantages preserved and maximized, and modem scientific technologies utilized, so as to promote the development of TCM theories and practice.
The stat shall encourage Chinese and Western medicine to Learn and Complement one another, develop with coordination and maximize their own advantages so as to promote the integration of Chinese and Western medicines.
The people’s governments at or above the county level shall incorporate TCM into their national economic and social development plans, to establish a sound TCM management system and make overall plans for the promotion and development of TCM.
The competent TCM administration department under the State Council shall take charge of the nationwide administration for TCM within its administrative region. Other relevant departments under the State Council shall take charge of other affairs related to TCM administration within their respective authority.
The competent TCM department under the local people’s government at or above the county level shall be responsible for the administration of TCM in their respective administrative regions. Other relevant departments of the local people’s governments at or above the county level shall be responsible for the affairs related to TCM administration within the scope of their respective functions.
Article 6 The state shall strengthen the construction of TCM service system, rationally plan and allocate TCM service resources and guarantee available access for citizens to TCM services.
China encourages social forces to invest in the TCM undertaking and supports organizations and individuals to make donation and provide fund for TCM undertaking.
The state shall promote TCM education to establish a TCM education system satisfying the needs during the developmental progress of TCM undertaking with proper scale, rational structure and different forms to cultivate TCM talents.
The state shall support the scientific research and technological development of TCM, encouraging innovation in TCM science and technologies, promote the application of scientific and technological achievements of TCM, protecting TCM intellectual property and promoting scientific and technological level of TCM.
The state shall support international exchange and cooperation to promote international transmission and application of TCM.
Organizations and individuals that have made outstanding contributions to the TCM undertaking shall be commended and rewarded in accordance with relevant provisions of China.
Chapter II TCM Services
The people’s governments or above the county level shall include the launch of TCM medical institutions into the plan on the setup of medical institutions, launching proper scaled TCM medical institutions, and supporting the development of medical institutions with distinct TCM features and advantages.
To merge or cancel a TCM medical institution launched by the government or convert it into a TCM institution, opinions shall be solicited from the competent TCM department under the people’s government at the next higher level.
The comprehensive hospitals and maternal and child care institutions and qualified specialized hospitals, community health service centers and township health centers launched by the government should set up TCM departments and clinics.
The people’s governments at or above the county level shall take measures to strengthen the capability of community health service stations and village clinics to provide TCM services.
The state supports non-governmental investment to launch Chinese medical institutions.
Chinese medical institutions launched by non-government investment shall enjoy the same rights as those organized by the government related to permission, practice, basic medical insurance, scientific research and teaching, the evaluation of titles for medical personnel, etc.
To launch a TCM medical institution, the 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.
To launch a TCM clinic, name, address, scope of service and staffing of the clinic shall be reported to the competent TCM department under the local people’s government at the county level and registered before starting medical practice. The TCM clinic shall publicize its medical treatment scope and the names of TCM practitioners and their practice scope in a visible position of the clinic. The clinic shall not conduct medical activities beyond the registered scope. The specific provisions shall be formulated by the competent TCM department under the State Council and be submitted to the administrative department of public health under the State Council for review and issuance.
Personnel engaged in medical activities of TCM shall, in accordance with the provisions of the Law of the People’s Republic of China on Medical Practitioners, obtain the qualification as a TCM physician through the TCM medical qualification examination, and conduct practice registration. The content of the qualificatio0n examination for TCM physician shall reflect TCM features.
A person who has been learning TCM from a teacher in form of apprenticeship, 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 by at least two TCM physicians, and may be qualified as a TCM physician after passing the appraisal and examination for the qualification of a licensed doctor under the auspices of the competent TCM department of the people’s government of the provinces, autonomous regions or municipalities directly under the Central Government. After conducting practice registration according to the examination content, he or she may be engaged in TCM medical activities in the form of 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 the personnel described in this paragraph according to the safety risks of TCM techniques and report the measures to the health administration department of the State Council for review and issuance.
A TCM institution shall mainly equipped with TCM professionals and technicians, mainly providing TCM services. TCM practitioners who have obtained physician qualification upon examinations may, in accordance with relevant provisions of China, adopt modern scientific and technological methods related to their professions in their medical practice after obtaining training and passing the examination. The modern scientific and technological methods applied in the medical activities shall be conductive to preserving and giving full play of TCM features and advantages.
The community health service centers, township health centers, community health service stations and qualified village clinics shall reasonably assign TCM professional technicians, and apply and promote appropriate TCM techniques.
TCM service shall be carried out by taking TCM theories as the guidance and applying TCM techniques and comply with basic requirements for TCM services formulated by the competent TCM department under the State Council.
The people’s government at or above the county level shall develop TCM in services of prevention and health care and incorporate them onto basic public health service items for overall planning and implementation in accordance with the relevant provisions of China.
The people’s governments at or above the county level shall allow TCM to fully play its role in emergency response to sudden public health events, and strengthen the reserves of TCM emergency response supplies, equipment, facilities, technologies and talents.
Medical and health institutions shall actively apply TCM theories and techniques in disease prevention and control.
A medical institution that plans to release a TCM medical advertisement shall be subject to the revision and approval of the competent TCM department of the people’s government without revision and approval. The content of the issued TCM medical advertisement shall be consistent with the content approved upon revision and comply with the relevant provisions of Advertising Law of the People’s Republic of China.
The competent TCM department under the people’s government at or above the county level shall strengthen the supervision and inspection of TCM service, and make the following items as the focus of the supervision and inspection:
The state shall improve the education system for TCM universities and vocational schools, and support the development of higher education institutions, secondary vocational schools and other educational institutions that specialize in the implementation of TCM education.
The training objectives, length of schooling, teaching mode, teaching content, teaching evaluation, and academic evaluation standard of TCM schools shall reflect the features of TCM disciplines and conform to the developmental rules of TCM disciplines.
The state shall develop TCM master-disciple education and support TCM physicians and technical TCM personnel with rich clinical experience and technical expertise to impart theories and technical methods to disciples to impart theories and technical methods to disciples in practice and medical activities to train professional towards medical personnel, especially those TCM technicians at the grass-root level in urban and rural areas.
The state shall strengthen the education and training for TCM physicians and professional TCM technical TCM personnel of the grass- root level in urban and rural areas.
The state shall develop education for integrated Chinese and Western medicine to cultivate high-level talents integrating TCM and Western medicine.
The competent TCM departments under the local people’s governments at or above the county level shall organize and develop TCM continuing education plans and strengthen basic TCM knowledge and skills training towards medical personnel, especially those TCM technicians at the grass-root level in urban and rural areas.
Professional TCM technician personnel shall participate in further education in accordance with the provisions, and local institutions shall create favorable conditions to support them.
Chapter V Scientific Research of TCM
The stat shall encourage scientific research institutions, higher education schools, medical institutions and pharmaceutical manufacturers to carry out scientific research on TCM by applying both modern scientific and techniques, strengthen the study on integration of Chinese and Western medicine, so as to promote the inheritance and innovation of TCM theories and technical methods.
The state shall take measures to support the collation, study and use of the ancient TCM literature, academic thoughts and diagnostics and treatment experience of famous TCM experts, and folk TCM technical techniques.
The state shall establish and improve the scientific and technological innovation system, evaluation system and administrative system that conform to TCM features so as to promote TCM scientific and technological progress and innovation.
The state shall take measures to strengthen the scientific research of basic TCM theories and treatment according to syndrome differentiation methods, prevention and treatment for common diseases, frequently occurring diseases, chronic diseases, major difficult diseases and major difficult diseases by means of TCM, and research projects, playing significant roles in the promotion pf theoretical and practical TCM development.
Chapter VI Inheritance and Cultural Communication of TCM
The competent TCM departments under the people's governments at or above the provincial level should organize the selection of academic heritage projects and successors of TCM within their respective administrative regions to carry forward TCM theories and technical methods with significant academic values and create favorable conditions for the inheritance. The inheritors shall carry out heritance activities to cultivate successors, and collect, collate and properly preserve relevant academic materials. The inheritance activities for representative projects of intangible cultural heritage, the inheritance activities shall be carried out in accordance with the relevant provisions of the Law of the people’s Republic of China on the Protection of Intangible Cultural Heritage.
The state shall establish the database, list and system for the protection of traditional knowledge of TCM.
Practitioners possessing TCM knowledge shall have the right to inherit and use their own knowledge. They shall have informed consent and shared interest for their TCM knowledge to be obtained and applied by others.
The state shall implement special protection for the composition and manufacturing of China secret prescriptions of traditional TCM identified according to law.
The state shall encourage the development of TCM health care and health preservation services and support non-governmental investments to launch standardized TCM health care institutions. The standards and criteria of TCM health care services shall be formulated by the competent TCM department under the State Council.
The people’s governments at or above the county level should strengthen the Public education of TCM knowledge and culture and encourage organizations and individuals to create TCM cultural and popular works.
Article 46 The activities for publicity and populari- zation TCM culture and knowledge should be carried out in compliance with the relevant provisions of the state. No or- ganization or individual shall make any false or exaggerated TCM publicity, nor shall they make fraudulent use of TCM to seek illegitimate interests.
The radio, television, newspaper, internet and other media shall employ professional TCM technical personnel when promoting TCM knowledge.
Chapter VII Safeguard Measures
The people’s governments at or above the county level should provide policy and material support for the TCM development, and incorporate the funds for the TCM development in the financial budgets of the governments at corresponding levels.
The people’s governments at or above the county level and relevant government authorities should invite the competent TCM department in drafting and developing policies for basic medical insurance payment, drug administration and other medical and health issues, so as to fully exploit TCM advantages to encourage practice and application of TCM services.
The people’s government at or above the county level and their relevant departments shall rationally set the charge items and standards of TCM services according to the statutory authority for price management, and reflect the cost of services and professional and technical values of TCM services。
In accordance with the provisions of the state, the relevant departments of the people’s governments at above the county level shall incorporate qualified TCM institutions of into the medical institution designated for basic medical insurance with the inclusion of qualified TCM diagnostic and treatment projects, TCM decoction pieces, Chinese patent medicine and self-made TCM preparation into the scope of basic medical insurance payment.
The state shall strengthen the construction of TCM standard system, develop standards for the technical requirements that need to be unified according to the TCM features and revise them in times.
The national and industrial TCM standards shall be formulated or revised by the relevant departments under the State Council in accordance with their responsibilities and be published on their websites for free-access to the public.
The state shall promote the establishment of the TCM international standard system.
The evaluation, assessment and appraisal of TCM required by the law and the administrative regulations shall be carried out with the launch of special organizations or the participation of TCM experts.
The state shall take measures to strengthen support towards ethnic minority medicine in inheritance and innovation, application- oriented development and talent cultivation and enhance the launch of medical institutions and establishment of physician team, so as to promote and standardize the development of ethnic minority medicine.
Chapter VIII Legal Liability
The competent TCM department of the people’s government at or above the county level and other relevant departments that fails to perform their duties as required by this Law shall be instructed for rectification by the people’s government at the same level or the relevant levels. If the circumstances are serious, the person directly in charge and other persons directly responsible shall be penalized according to law.
Any TCM clinic, in violation of the provisions of this Law, that carries out medical activities beyond the registered practice scope shall be instructed to rectify by the competent TCM department under the local people’s government at the county level, and the illegal gains shall be confiscated and impose with a fine of not less than RMB 10,000 yuan but not more than RMB 30,000 yuan. If the circumstances are serious, it shall be instructed to cease the practice.
For any TCM clinic instructed to cease the practice, the person directly in charge shall be barred from being engaged in the management of medical institutions within five years from the issuance date of the penalty decision, For any medical institution that hires the above-mentioned persons to engage in the management work, the medical practice license shall be revoked by the former license issuance department or the institution shall be instructed to cease the practice by the former registration department.
Any TCM physician obtained qualification of a licensed doctor after passing the examination who is engaged in medical activities beyond the registered practice scope, in violation of the provision of this Law, shall be instructed to suspend the practice for not less than six months but not more than one year by the competent TCM departments under the people’s governments at or above the county level and impose a five of not less than RMB 10,000 yuan but not more than RMB 30,000 yuan. If the circumstances are serious, his/her medical practice license shall be revoked.
In case of failure in record keeping of filling with false materials in launching TCM clinic, processing decoction pieces or entrusting others to prepare Chinese medicinal preparation in violation of the provisions of this Law, offenders shall be instructed to rectify by the competent TCM department and pharmaceutical supervision and administrative department according to their respective responsibilities. The illegal gains shall be confiscated sand impose a fine of not more than RMB 30,000 yuan and the relevant information should be publicized. If offenders refuse to rectify, they shall be instructed to cease the practice or the processing for TCM decoction pieces and the entrusted TCM preparation, and the person directly responsible shall be barred from being engaged in any TCM activities within five years from the date of the issuance of the penalty decision.
Any TCM institution fails to record on files when applying traditional process to prepare Chinese medicinal preparation in violation of the provision of this Law, or ails to make Chinese medicinal preparation on accordance with the requirements stated clearly in the record files shall be penalized as producing counterfeit.
In case of releasing a TCM advertisement not in conformity with the reviewed and approved edition, in violation of the provisions of this Law, the regulatory department responsible for the approval will revoke the approval document for the advertisement and dismiss the application for advertising review submitted by this medical institution within one year.
In violation of the provisions of this Law, other illegal actions when releasing TCM advertisement, offenders shall be penalized in accordance with the provisions of the Advertising Law of the People’s Republic of China.
In case of using high-toxic pesticides in the process of planting Chinese materia medica, in violation of the provision of this Law, offenders shall be penalized in accordance with the relevant laws and administrative regulations; If the circumstances are serious, the person directly in charge or other persons directly responsible may be detained by the public security organ for not less than five days but not more than 15 days.
In the case of causing personal of property damage in violation of the relevant provisions of this Law, the offender shall bear civil liability in accordance with the Law. In case of violation this Law involving criminal offenses, the offenders shall be prosecuted in accordance with the law.
Chapter IX Supplementary Provisions
The administration of TCM that is not specified by this Law shall apply to the provisions of relevant law and administrative regulations such as the Law of the People’s Republic of China on Medical Practitioners and the Drug Administration Law of the People’s Republic if China.
The administration of TCM in the armed forces shall be organized and implemented by the military health authorities in accordance with this Law and the relevant provisions of the armed forces.
Autonomous regions of ethnic minorities may formulate measures to promote and standardize the development of local ethnic minority medicine based on their practical situations, in accordance with the Law of the People’s Republic of China on Regional National Autonomy and the relevant provisions of this Law.
If the blind obtain qualification for braille medical massage personnel in accordance with the relevant provisions of China, medical massage services could be provided in the form of an individual business or within a medical institution.
The law shall come into force as the July 1,2017
Notes for Several Terms
1 中医药 (traditional Chinese medicine)
Experts share different views on the translation of “中医药”. Experts abroad prefer to translate the term into “Chinese medicine”. They feel that Chinese medicine is not traditional at all and it has been developing all the time. The term, Chinese medicine, is more favorable in promoting the application and spread of Chinese medicine, However, experts and scholars in China point out that traditional Chinese medicine (TCM) is acknowledged and accepted by the world without any meaning pertaining to tradition or not developing. After searching relevant literature, the compile group found that “中医药” in White Paper: Traditional Chinese Medicine in China issued by China’s State Council Information Office and Regulations of the People’s Republic of China on Traditional Chinese Medicine issued by the Stated Council of the People’s Republic of China is translated as “traditional Chinese medicine”. Upon overall consideration on the above reasons, “中医药”in WFCMS’s version finally is translated into “traditional Chinese medicine(TCM)”.
2. 中药材 （Chinese crude drug）
In the reference materials, the terms of “中药” and “中药材” have a variety of translation, For instance, Regulations of the People’s Republic of China on Traditional Chinese Medicine issued by the State Council of the People’s Republic of China translates “中药材”into “Chinese medical substances”, however this translation is not commonly used and also let the reader misunderstand what it is referred to; “中药材” is translated as “Chinese Materia Medica” in standards of ISO/TC249, but it is often used to express the concept of the discipline of pharmacy; while “中药材”also is translated into ”Chinese crude drug” in several TCM standards, which is specifically clear and easy for understanding. Therefore, in order to avoid the repetition of using the same term to express different Chinese terms, we translate “中药”as “Chinese Materia Medica”, “中药材”as “Chinese crude drug” and “道地药材”as “genuine regional crude drug”, in order to avoid ambiguousness.
3.中医药人才培养 （Education and Training of Traditional Chinese Medicine）
By literal translation, the title of the third chapter “中医药人才培养” should be translated as “Cultivation of Traditional Chinese Medicine Talents”. Many overseas experts feel this translation is too blunt. In order to better convey the connotation of the Law, “中医药人才培养” is translated as “Education and Training of Traditional Chinese Medicine”, based on the specific content of the third chapter, in order to adhere to the reading habits of targeted readers and ensure the effective convey of contents and cultural connotation.
4.社会力量 (non-government sectors)
By literal translation, “社会力量” should be translated as “social forces” and the definition given in the English dictionary is that an element of society which has the capability of causing cultural change or influences people. However, the term in the Law has different meaning. According to Interpretation to Law of the People’s Republic of China on Traditional Chinese Medicine, “社会力量” refers to the non-government social capitals, and then the translation of “non-government sectors” is adopted, as we found this expression in UN documents and many English native-language news.
 http: //www.scio.gov.cn/zfbps/32832/Document/1534713/1534713.htm
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 UNITED NATIONS POPULATION INFORMATION NETWORK (POPIN) UN Populaltion Division, Department of Economic Social Affairs, with support from the UN Population Fund (UNFPA) http: //www.un.org/popin/icpd/prepcomm/official/rap/RAP14.html
 Database of Law and Regulations
 Law of the People’s Republic of China on Traditional Chinese Medicine
http: //www.lawinfochina.com/display.aspx? id = 22978&lib =law#