中华人民共和国中医药法(中英文对照版)

《中华人民共和国中医药法》已由中华人民共和国第十二届全国人民代表大会常务委员会第二十五次会议于2016年12月25日通过,现予公布,自2017年7月1日起施行。

法律文本

中华人民共和国中医药法

Laws of the PRC on Traditional Chinese Medicine

主席令第五十九号

Presidential Decree No. 59

《中华人民共和国中医药法》已由中华人民共和国第十二届全国人民代表大会常务委员会第二十五次会议于20161225日通过,现予公布,自201771日起施行。

The Traditional Chinese Medicine Law of the People's Republic of China, adopted at the 25th Session of the Standing Committee of the 12th National People's Congress on 25 December 2016, is hereby promulgated, effective as of 1 July 2017.

中华人民共和国主席 习近平

President Xi Jinping

20161225

December 25, 2016

20161225日第十二届全国人民代表大会常务委员会第二十五次会议通过)

(Adopted at the 25th Session of the Standing Committee of the 12th National People's Congress on December 25, 2016)

第一章

Chapter 1 General Provisions

第一条   为了继承和弘扬中医药,保障和促进中医药事业发展,保护人民健康,制定本法。

Article 1 This Law is enacted in order to inherit and carry forward traditional Chinese medicine (TCM), ensure and promote the development of TCM undertaking and protect the health of the people.

第二条   本法所称中医药,是包括汉族和少数民族医药在内的我国各民族医药的统称,是反映中华民族对生命、健康和疾病的认识,具有悠久历史传统和独特理论及技术方法的医药学体系。

Article 2 For the purpose of this Law, TCM refers to the general designation of medicines of all ethnicities in China, including those of Han and minority ethnicities, which reflects the knowledge of the Chinese nation about life, health and diseases, and has a long historical tradition and unique theories and technical methods.

第三条   中医药事业是我国医药卫生事业的重要组成部分。国家大力发展中医药事业,实行中西医并重的方针,建立符合中医药特点的管理制度,充分发挥中医药在我国医药卫生事业中的作用。

Article 3 TCM undertaking is an important part of China's medicine and health undertakings. The State exerts every effort to develop the TCM undertaking, follows the principle of attaching equal importance to TCM and Western medicine (WM), and sets up the administrative system in line with the characteristics of TCM to bring the role of TCM in the development of China's medicine and health undertakings into full play.

发展中医药事业应当遵循中医药发展规律,坚持继承和创新相结合,保持和发挥中医药特色和优势,运用现代科学技术,促进中医药理论和实践的发展。

To develop TCM undertaking, we shall comply with the development rules of TCM, insist on combining inheritance with innovation, maintain and give play to the characteristics and advantages of TCM, apply modern science and technology, and promote the development of TCM theories and practice.

国家鼓励中医西医相互学习,相互补充,协调发展,发挥各自优势,促进中西医结合。

The State encourages the mutual learning and supplementation between TCM and WM, the coordinated development of them and the application of their respective advantages, to promote the integration between TCM and WM.

第四条   县级以上人民政府应当将中医药事业纳入国民经济和社会发展规划,建立健全中医药管理体系,统筹推进中医药事业发展。

Article 4 People's governments at the county level or above shall incorporate the TCM undertaking into their national economic and social development plans, establish and improve TCM administration systems, and promote the development of the TCM undertaking under overall planning.

第五条   国务院中医药主管部门负责全国的中医药管理工作。国务院其他有关部门在各自职责范围内负责与中医药管理有关的工作。

Article 5 The competent TCM department under the State Council shall take charge of TCM administration nationwide. Other relevant departments under the State Council shall, within the scope of their respective responsibilities, take charge of the affairs in connection with TCM administration.

县级以上地方人民政府中医药主管部门负责本行政区域的中医药管理工作。县级以上地方人民政府其他有关部门在各自职责范围内负责与中医药管理有关的工作。

The competent TCM departments under the local people's governments at the county level or above shall take charge of TCM administration within their respective administrative regions. Other relevant departments under the local people's governments at the county level or above shall, within the scope of their respective responsibilities, take charge of the affairs in connection with TCM administration.

第六条   国家加强中医药服务体系建设,合理规划和配置中医药服务资源,为公民获得中医药服务提供保障。

Article 6 The State will strengthen the building of a TCM service system, reasonably make plans for and allocate TCM service resources, and provide a guarantee for citizens' access to TCM services.

国家支持社会力量投资中医药事业,支持组织和个人捐赠、资助中医药事业。

The State supports private capitals to invest in the TCM undertaking, and supports organizations and individuals to donate to and fund the TCM undertaking.

第七条   国家发展中医药教育,建立适应中医药事业发展需要、规模适宜、结构合理、形式多样的中医药教育体系,培养中医药人才。

Article 7 The State will develop TCM education, establish a system for TCM education that complies with the requirements of the development of the TCM undertaking and has proper scale, reasonable structure and diverse forms to cultivate TCM talents.

第八条   国家支持中医药科学研究和技术开发,鼓励中医药科学技术创新,推广应用中医药科学技术成果,保护中医药知识产权,提高中医药科学技术水平。

Article 8 The State supports TCM scientific research and technological development, encourages innovation in TCM science and technology, promotes the application of achievements in TCM science and technology, protects TCM intellectual property rights, and improves the level of TCM science and technology.

第九条   国家支持中医药对外交流与合作,促进中医药的国际传播和应用。

Article 9 The State supports foreign exchange and cooperation in regard to TCM to promote the dissemination and application of TCM internationally.

第十条   对在中医药事业中做出突出贡献的组织和个人,按照国家有关规定给予表彰、奖励。

Article 10 Commendation, honors or awards shall be granted to organizations and individuals making outstanding contributions to the development of the TCM undertaking in accordance with the relevant national provisions.

第二章 中医药服务

Chapter 2 TCM Services

第十一条   县级以上人民政府应当将中医医疗机构建设纳入医疗机构设置规划,举办规模适宜的中医医疗机构,扶持有中医药特色和优势的医疗机构发展。

Article 11 People's governments at the county level or above shall incorporate the building of TCM medical institutions into the planning related to the establishment of medical institutions, set up TCM medical institutions of proper scale, and support the development of medical institutions with TCM characteristics and advantages.

合并、撤销政府举办的中医医疗机构或者改变其中医医疗性质,应当征求上一级人民政府中医药主管部门的意见。

For merging or canceling a TCM medical institution set up by the government or changing its TCM medical nature, opinions shall be sought from the competent TCM department under the people's government at the next higher level.

第十二条   政府举办的综合医院、妇幼保健机构和有条件的专科医院、社区卫生服务中心、乡镇卫生院,应当设置中医药科室。

Article 12 General hospitals, maternity and child care institutions, as well as qualified specialized hospitals, community health service centers and township health centers sponsored by the government shall set up a TCM department.

县级以上人民政府应当采取措施,增强社区卫生服务站和村卫生室提供中医药服务的能力。

People's governments at and above county level shall take measures to enhance the ability of community health service stations and village health clinics to provide TCM services.

第十三条   国家支持社会力量举办中医医疗机构。

Article 13 The State supports the establishment of TCM medical institutions with private capital.

社会力量举办的中医医疗机构在准入、执业、基本医疗保险、科研教学、医务人员职称评定等方面享有与政府举办的中医医疗机构同等的权利。

TCM medical institutions established with private capital are entitled to the same rights as those established by the government in respect of access, practice, basic medical insurance, scientific research and teaching, and medical personnel title assessment.

第十四条   举办中医医疗机构应当按照国家有关医疗机构管理的规定办理审批手续,并遵守医疗机构管理的有关规定。

Article 14 The establishment of a TCM medical institution shall, according to the national provisions on the administration of medical institutions, be subject to examination and approval procedures and the provisions concerning the administration of medical institutions.

举办中医诊所的,将诊所的名称、地址、诊疗范围、人员配备情况等报所在地县级人民政府中医药主管部门备案后即可开展执业活动。中医诊所应当将本诊所的诊疗范围、中医医师的姓名及其执业范围在诊所的明显位置公示,不得超出备案范围开展医疗活动。具体办法由国务院中医药主管部门拟订,报国务院卫生行政部门审核、发布。

For the establishment of a TCM clinic, the clinic may carry out practicing activities after reporting its name, address, diagnosis and treatment scope, and staffing to the competent TCM department under the people's government at the county level of the place where the clinic is located for filing. The TCM clinic shall publicize its diagnosis and treatment scope, TCM physicians' names and their practice scopes at an eye-catching position of the clinic and shall not conduct medical treatment activities beyond the scope as filed. The specific measures shall be drafted by the competent TCM department under the State Council and submitted to the health administrative department under the State Council for review and issuance.

第十五条   从事中医医疗活动的人员应当依照《中华人民共和国执业医师法》的规定,通过中医医师资格考试取得中医医师资格,并进行执业注册。中医医师资格考试的内容应当体现中医药特点。

Article 15 The personnel engaging in TCM medical activities shall, in accordance with the Law of the People's Republic of China on Medical Practitioners, be qualified as TCM physicians after passing the TCM physician qualification examination, and go through the practice registration. The content of the TCM physician qualification examination shall reflect the characteristics of TCM.

以师承方式学习中医或者经多年实践,医术确有专长的人员,由至少两名中医医师推荐,经省、自治区、直辖市人民政府中医药主管部门组织实践技能和效果考核合格后,即可取得中医医师资格;按照考核内容进行执业注册后,即可在注册的执业范围内,以个人开业的方式或者在医疗机构内从事中医医疗活动。国务院中医药主管部门应当根据中医药技术方法的安全风险拟订本款规定人员的分类考核办法,报国务院卫生行政部门审核、发布。

A person studying TCM from a master as a disciple or acquiring specialized knowledge of medicine through years' practice may be qualified as a TCM physician with recommendations from at least two TCM physicians and after passing the examination on practice skills and effects organized by the competent TCM department under the local people's government of the province, autonomous region, or municipality directly under the Central Government; and upon practice registration in compliance with the assessment content, the person may, within the registered scope of practice, engage in TCM medical treatment activities in self-employment or in medical institutions. The competent TCM department under the State Council shall, according to the safety risks of TCM technical methods, draw up classified examination measures for the person set out in this paragraph, and submit the same to the health administrative department under the State Council for review and issuance.

第十六条   中医医疗机构配备医务人员应当以中医药专业技术人员为主,主要提供中医药服务;经考试取得医师资格的中医医师按照国家有关规定,经培训、考核合格后,可以在执业活动中采用与其专业相关的现代科学技术方法。在医疗活动中采用现代科学技术方法的,应当有利于保持和发挥中医药特色和优势。

Article 16 TCM medical institutions shall be staffed by medical personnel who are mainly TCM professionals and mainly provide TCM services; TCM physicians who have obtained the physician qualification upon examination may, in accordance with the relevant provisions of the State, adopt modern scientific and technological methods relating to their specialties in practice activities after receiving training and passing the examination. The modern scientific methods adopted in medical activities shall be favorable to maintain and give play to the characteristics and advantages of traditional Chinese medicine.

社区卫生服务中心、乡镇卫生院、社区卫生服务站以及有条件的村卫生室应当合理配备中医药专业技术人员,并运用和推广适宜的中医药技术方法。

Community health service centers, township health centers, community health service stations and qualified village health clinics shall be reasonably staffed by TCM professionals to apply and popularize appropriate TCM technical methods.

第十七条   开展中医药服务,应当以中医药理论为指导,运用中医药技术方法,并符合国务院中医药主管部门制定的中医药服务基本要求。

Article 17 TCM services shall be performed with the TCM theories as the guidance and the application of TCM technical methods, as well as in line with the basic requirements on TCM services formulated by the competent TCM department under the State Council.

第十八条   县级以上人民政府应当发展中医药预防、保健服务,并按照国家有关规定将其纳入基本公共卫生服务项目统筹实施。

Article 18 People's governments at the county level or above shall develop TCM precaution and healthcare services and, in accordance with the relevant national provisions, include them in the basic public health service items for implementation under overall arrangement.

县级以上人民政府应当发挥中医药在突发公共卫生事件应急工作中的作用,加强中医药应急物资、设备、设施、技术与人才资源储备。

People's governments at the county level or above shall give play to the role of TCM in the emergency response to sudden public health incidents and strengthen the reserves of TCM emergency supplies, equipment, facilities, technologies and talent resources.

医疗卫生机构应当在疾病预防与控制中积极运用中医药理论和技术方法。

Medical and health institutions shall apply TCM theories and technical methods actively in disease prevention and control.

第十九条   医疗机构发布中医医疗广告,应当经所在地省、自治区、直辖市人民政府中医药主管部门审查批准;未经审查批准,不得发布。发布的中医医疗广告内容应当与经审查批准的内容相符合,并符合《中华人民共和国广告法》的有关规定。

Article 19 Medical institutions shall publish TCM medical advertisements subject to the examination and approval by the competent TCM departments under the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where the medical institutions are located; and without the examination and approval, no TCM medical advertisement shall be published. The content of any TCM advertisement shall conform to the content examined and approved and the relevant provisions of the Advertising Law of the People's Republic of China.

第二十条   县级以上人民政府中医药主管部门应当加强对中医药服务的监督检查,并将下列事项作为监督检查的重点:

Article 20 The competent TCM departments under the people's governments at the county level or above shall strengthen the supervision and inspection of TCM services with the following matters as the focuses:

(一)中医医疗机构、中医医师是否超出规定的范围开展医疗活动;

1. whether a TCM medical institution or a TCM physician carries out medical treatment activities beyond the scope as prescribed;

(二)开展中医药服务是否符合国务院中医药主管部门制定的中医药服务基本要求;

2. whether the TCM services provided meet the basic requirements on TCM services formulated by the competent TCM department under the State Council; and

(三)中医医疗广告发布行为是否符合本法的规定。

3. whether the publishing of TCM advertisements meets the provisions hereof.

中医药主管部门依法开展监督检查,有关单位和个人应当予以配合,不得拒绝或者阻挠。

Relevant entities and individuals shall cooperate with and shall not refuse or obstruct the supervision and inspection launched by the competent TCM departments according to the law.

第三章 中药保护与发展

Chapter 3 Protection and Development of CHMs

第二十一条   国家制定中药材种植养殖、采集、贮存和初加工的技术规范、标准,加强对中药材生产流通全过程的质量监督管理,保障中药材质量安全。

Article 21 The State will formulate the technical specifications and standards on the cultivation, breeding, storage and initial processing of CHMs, and strengthen the quality supervision and management of the whole process of production and circulation of CHMs to guarantee the quality and safety of CHMs.

第二十二条   国家鼓励发展中药材规范化种植养殖,严格管理农药、肥料等农业投入品的使用,禁止在中药材种植过程中使用剧毒、高毒农药,支持中药材良种繁育,提高中药材质量。

Article 22 The State encourages the development of standardized plantation and cultivation of CHMs, strictly controls the use of agricultural inputs such as pesticides and fertilizers, prohibits the use of extremely toxic or highly toxic pesticides on a CHM plantation, and supports the breeding of fine varieties to raise the quality of CHMs.

第二十三条   国家建立道地中药材评价体系,支持道地中药材品种选育,扶持道地中药材生产基地建设,加强道地中药材生产基地生态环境保护,鼓励采取地理标志产品保护等措施保护道地中药材。

Article 23 The State will establish an evaluation system for genuine CHMs, support the breeding of genuine CHM varieties, assist in the building of production bases for genuine CHMs, enhance the eco-environmental protection of the production bases for genuine CHMs, and encourage the protection of genuine CHMs through measures such as the protection of geographical indication products.

前款所称道地中药材,是指经过中医临床长期应用优选出来的,产在特定地域,与其他地区所产同种中药材相比,品质和疗效更好,且质量稳定,具有较高知名度的中药材。

For the purpose of the preceding paragraph, genuine CHMs refer to CHMs that are selected based on the TCM clinical application for the long term, have better quality and efficacy compared with those produced in other regions, and have reliable quality and high reputation.

第二十四条   国务院药品监督管理部门应当组织并加强对中药材质量的监测,定期向社会公布监测结果。国务院有关部门应当协助做好中药材质量监测有关工作。

Article 24 The department of drug supervision and administration under the State Council shall organize and strengthen the CHM quality monitoring and publish the monitoring results to the public periodically. Relevant departments under the State Council shall assist in effectively handling affairs in connection with CHM quality monitoring.

采集、贮存中药材以及对中药材进行初加工,应当符合国家有关技术规范、标准和管理规定。

The collection, storage and preliminary processing of CHMs shall comply with the relevant national technical specifications, standards and administrative provisions.

国家鼓励发展中药材现代流通体系,提高中药材包装、仓储等技术水平,建立中药材流通追溯体系。药品生产企业购进中药材应当建立进货查验记录制度。中药材经营者应当建立进货查验和购销记录制度,并标明中药材产地。

The State encourages the development of a modern CHM circulation system, the improvement of the packaging, storage and other technologies, and the establishment of a traceability system for CHM circulation. Drug manufacturers shall establish a system of entry inspection and record for the purchase of CHMs. CHM operators shall establish a system of entry inspection and record of purchase and sales, and mark the origins of CHMs.

第二十五条   国家保护药用野生动植物资源,对药用野生动植物资源实行动态监测和定期普查,建立药用野生动植物资源种质基因库,鼓励发展人工种植养殖,支持依法开展珍贵、濒危药用野生动植物的保护、繁育及其相关研究。

Article 25 The State protects officinal resources of wild animals and plants under a dynamic monitoring and periodical census system, has set up a germplasm gene bank, encourages the development of artificial plantation and cultivation, and supports activities related to the protection and reproduction of precious and endangered officinal wild animals and plants as well as relevant research.

第二十六条   在村医疗机构执业的中医医师、具备中药材知识和识别能力的乡村医生,按照国家有关规定可以自种、自采地产中药材并在其执业活动中使用。

Article 26 TCM physicians practicing in village medical institutions and village doctors who have CHM knowledge and identification ability may grow and collect genuine CHMs themselves and use them in their practicing activities in accordance with the relevant state provisions.

第二十七条   国家保护中药饮片传统炮制技术和工艺,支持应用传统工艺炮制中药饮片,鼓励运用现代科学技术开展中药饮片炮制技术研究。

Article 27 The State protects the traditional preparation technology and processes of Chinese herbal pieces, supports the application of traditional processes to prepare Chinese herbal pieces and encourages the research on the preparation technology for Chinese herbal pieces by using modern scientific technologies.

第二十八条   对市场上没有供应的中药饮片,医疗机构可以根据本医疗机构医师处方的需要,在本医疗机构内炮制、使用。医疗机构应当遵守中药饮片炮制的有关规定,对其炮制的中药饮片的质量负责,保证药品安全。医疗机构炮制中药饮片,应当向所在地设区的市级人民政府药品监督管理部门备案。

Article 28 For Chinese herbal pieces not available on the market, a medical institution may, according to the prescription issued by its physicians, prepare and use the Chinese herbal pieces itself. The medical institution shall comply with relevant provisions on the preparation of Chinese herbal pieces, be liable for the quality of the Chinese herbal pieces it prepares and ensure their safety. If any medical institution prepares Chinese herbal pieces, it shall file a record with the department of drug supervision and administration under the people's government of the city divided into districts where it is located.

根据临床用药需要,医疗机构可以凭本医疗机构医师的处方对中药饮片进行再加工。

A medical institution may reprocess Chinese herbal pieces by virtue of prescriptions issued by its physicians to satisfy its needs in clinical medication.

第二十九条   国家鼓励和支持中药新药的研制和生产。

Article 29 The State encourages and supports the research, development and production of new CHMs.

国家保护传统中药加工技术和工艺,支持传统剂型中成药的生产,鼓励运用现代科学技术研究开发传统中成药。

The State protects the processing technologies and techniques for traditional Chinese medicine, supports the production of traditional Chinese patent medicines in dosage forms and encourages the research and development thereof by using modern scientific technologies.

第三十条   生产符合国家规定条件的来源于古代经典名方的中药复方制剂,在申请药品批准文号时,可以仅提供非临床安全性研究资料。具体管理办法由国务院药品监督管理部门会同中医药主管部门制定。

Article 30 For the production of a CHM combination preparation in compliance with requirements prescribed by the State and based on a classical prescription, the relevant drug manufacturer may, when applying for a drug approval number, provide materials on non-clinical safety research only. The specific administrative measures shall be formulated by the drug regulatory department under the State Council in concert with the competent TCM department under the State Council.

前款所称古代经典名方,是指至今仍广泛应用、疗效确切、具有明显特色与优势的古代中医典籍所记载的方剂。具体目录由国务院中医药主管部门会同药品监督管理部门制定。

For the purpose of the preceding paragraph, a classical prescription refers to any prescription recorded in ancient TCM classics that has been widely applied up to the present and has definite curative effects as well as remarkable characteristics and advantages. The specific catalogue shall be formulated by the competent TCM department under the State Council in concert with the department of drug supervision and administration under the State Council.

第三十一条   国家鼓励医疗机构根据本医疗机构临床用药需要配制和使用中药制剂,支持应用传统工艺配制中药制剂,支持以中药制剂为基础研制中药新药。

Article 31 The State encourages medical institutions to prepare and use CHM preparations according to their clinical medication needs, supports the application of traditional processes to prepare CHM preparations as well as the research and development of new CHMs on the basis of CHM preparations.

医疗机构配制中药制剂,应当依照《中华人民共和国药品管理法》的规定取得医疗机构制剂许可证,或者委托取得药品生产许可证的药品生产企业、取得医疗机构制剂许可证的其他医疗机构配制中药制剂。委托配制中药制剂,应当向委托方所在地省、自治区、直辖市人民政府药品监督管理部门备案。

Any medical institution intending to prepare CHM preparations shall, in accordance with the Drug Administration Law of the People's Republic of China, acquire the pharmaceutical preparation certificate for medical institutions or commission a drug manufacturing enterprise acquiring the drug manufacturing certificate or any other medical institution acquiring the pharmaceutical preparation certificate for medical institutions to prepare the CHM preparations. In the case of commissioned preparation of CHM preparations, the commissioning institution shall file the commissioned preparation for record with the department of drug supervision and administration under the people's government of the province, autonomous region or municipality directly under the Central Government where it is located.

医疗机构对其配制的中药制剂的质量负责;委托配制中药制剂的,委托方和受托方对所配制的中药制剂的质量分别承担相应责任。

A medical institution shall be responsible for the quality of its dispensed traditional Chinese medicine preparations. Where a traditional Chinese medicine preparation is dispensed under entrustment, both the client and the entrusted shall take their respective responsibilities for the quality of the dispensed preparation.

第三十二条   医疗机构配制的中药制剂品种,应当依法取得制剂批准文号。但是,仅应用传统工艺配制的中药制剂品种,向医疗机构所在地省、自治区、直辖市人民政府药品监督管理部门备案后即可配制,不需要取得制剂批准文号。

Article 32 A medical institution shall acquire according to law a registered number of preparation approvals for the CHM preparation varieties it prepares. However, for the varieties of CHM preparation for which only traditional techniques are applied, no registered number of preparation approvals is required and the institution may prepare them by filing a record at the department of drug supervision and administration under the people's government of the province, autonomous region, or municipality directly under the Central Government of the place where the institution is located.

医疗机构应当加强对备案的中药制剂品种的不良反应监测,并按照国家有关规定进行报告。药品监督管理部门应当加强对备案的中药制剂品种配制、使用的监督检查。

Any medical institution shall strengthen monitoring on the adverse drug reactions of the filed CHM preparation varieties and make a report according to the relevant national provisions. All departments of drug supervision and administration shall strengthen the supervision and inspection on the preparation and use of the filed CHM preparation varieties.

第四章 中医药人才培养

Chapter 4 Training of TCM Personnel

第三十三条   中医药教育应当遵循中医药人才成长规律,以中医药内容为主,体现中医药文化特色,注重中医药经典理论和中医药临床实践、现代教育方式和传统教育方式相结合。

Article 33 TCM education shall comply with the rules of growth of TCM talents, with the TCM content as the core to represent the characteristics of TCM culture, as well as emphasis on the combination of classical TCM theories and clinical TCM practice, modern education means and traditional education means.

第三十四条   国家完善中医药学校教育体系,支持专门实施中医药教育的高等学校、中等职业学校和其他教育机构的发展。

Article 34 The State will improve the education systems of TCM schools and support the development of higher-education schools, secondary vocational schools and other educational institutions that specially implement TCM education.

中医药学校教育的培养目标、修业年限、教学形式、教学内容、教学评价及学术水平评价标准等,应当体现中医药学科特色,符合中医药学科发展规律。

The cultivation objectives, required schooling years, teaching forms, teaching content, teaching evaluation and academic evaluation standards for academic level of the TCM schools' education shall reflect the characteristics of the discipline of TCM and comply with the law of development of the discipline.

第三十五条   国家发展中医药师承教育,支持有丰富临床经验和技术专长的中医医师、中药专业技术人员在执业、业务活动中带徒授业,传授中医药理论和技术方法,培养中医药专业技术人员。

Article 35 The State will develop the TCM master-disciple education, support TCM physicians and HCM professionals with rich clinical experience and expertise to guide students in practice and business activities, and teach TCM theories and technical methods, to cultivate TCM professionals.

第三十六条   国家加强对中医医师和城乡基层中医药专业技术人员的培养和培训。

Article 36 The State strengthens the cultivation and training for TCM physicians and TCM professionals at grassroots level in urban and rural areas.

国家发展中西医结合教育,培养高层次的中西医结合人才。

The State promotes the education of integrated traditional Chinese medicine and Western medicine to cultivate high-level talents of integrated traditional Chinese medicine and Western medicine.

第三十七条   县级以上地方人民政府中医药主管部门应当组织开展中医药继续教育,加强对医务人员,特别是城乡基层医务人员中医药基本知识和技能的培训。

Article 37 The competent TCM departments under the local people's governments at the county level or above shall organize and launch the continuing education on TCM and strengthen the training on basic TCM knowledge and skills for medical personnel, especially for those at grassroots level in urban and rural areas.

中医药专业技术人员应当按照规定参加继续教育,所在机构应当为其接受继续教育创造条件。

TCM professionals shall participate in continuing education as required and the institutions where they work shall create conditions for them to accept continuing education.

第五章 中医药科学研究

Chapter 5 Research on TCM Science

第三十八条   国家鼓励科研机构、高等学校、医疗机构和药品生产企业等,运用现代科学技术和传统中医药研究方法,开展中医药科学研究,加强中西医结合研究,促进中医药理论和技术方法的继承和创新。

Article 38 The State encourages research institutions, institutions of higher education, medical institutions and drug manufacturers to conduct scientific research on TCM and strengthen the research on the integration of TCM and WM to promote the inheritance and innovation regarding TCM theories and technical methods by applying modern science and technology as well as traditional TCM research methodologies.

第三十九条   国家采取措施支持对中医药古籍文献、著名中医药专家的学术思想和诊疗经验以及民间中医药技术方法的整理、研究和利用。

Article 39 The State will take measures to support the sorting, research and utilization regarding ancient TCM books and literature, academic thoughts and experience in diagnosis and treatment of well-known TCM experts, as well as folk TCM technical methods.

国家鼓励组织和个人捐献有科学研究和临床应用价值的中医药文献、秘方、验方、诊疗方法和技术。

The State encourages organizations and individuals to donate TCM literature, secret prescriptions, proved prescriptions, diagnosis methods and technologies having the value of scientific research and clinical application.

第四十条   国家建立和完善符合中医药特点的科学技术创新体系、评价体系和管理体制,推动中医药科学技术进步与创新。

Article 40 The State will establish and improve systems of scientific and technological innovation, evaluation and management that comply with the characteristics of TCM to advance the progress and innovation in TCM science and technology.

第四十一条   国家采取措施,加强对中医药基础理论和辨证论治方法,常见病、多发病、慢性病和重大疑难疾病、重大传染病的中医药防治,以及其他对中医药理论和实践发展有重大促进作用的项目的科学研究。

Article 41 The State will take measures to strengthen the scientific research on basic TCM theories and methods of syndrome identification and treatment, TCM prevention and treatment in respect of common and frequently occurring diseases, chronic diseases and serious refractory diseases, and serious infectious diseases, as well as other projects that will significantly facilitate the development of TCM theories and practices.

第六章 中医药传承与文化传播

Chapter 6 Traditional Chinese Medicine Inheritance and Cultural Communication

第四十二条   对具有重要学术价值的中医药理论和技术方法,省级以上人民政府中医药主管部门应当组织遴选本行政区域内的中医药学术传承项目和传承人,并为传承活动提供必要的条件。传承人应当开展传承活动,培养后继人才,收集整理并妥善保存相关的学术资料。属于非物质文化遗产代表性项目的,依照《中华人民共和国非物质文化遗产法》的有关规定开展传承活动。

Article 42 For TCM theories and technical methods of important academic value, the competent TCM departments under the people's governments at the provincial level or above shall organize and select TCM academic inheritance projects and inheritors within their administrative regions and provide the necessary conditions for the inheritance activities. The inheritors shall conduct inheritance activities, cultivate successors, collect, sort out and properly keep relevant academic materials. For a representative project of intangible cultural heritage, inheritance activities shall be conducted in accordance with the Intangible Cultural Heritage Law of the People's Republic of China.

第四十三条   国家建立中医药传统知识保护数据库、保护名录和保护制度。

Article 43 The State establishes the protection database, protection catalogue and protection system for traditional TCM knowledge.

中医药传统知识持有人对其持有的中医药传统知识享有传承使用的权利,对他人获取、利用其持有的中医药传统知识享有知情同意和利益分享等权利。

Persons having traditional TCM knowledge are entitled to inherit and use the knowledge they have, and have the right of informed consent and interest sharing on their traditional TCM knowledge acquired and used by others.

国家对经依法认定属于国家秘密的传统中药处方组成和生产工艺实行特殊保护。

The State exercises special protection of the composition and production process of TCM prescriptions that are legally recognized as national secrets.

第四十四条   国家发展中医养生保健服务,支持社会力量举办规范的中医养生保健机构。中医养生保健服务规范、标准由国务院中医药主管部门制定。

Article 44 The State promotes TCM health care services, and supports private efforts in organizing standardized TCM health care institutions. The specifications and standards for TCM health care services shall be formulated by the competent TCM department under the State Council.

第四十五条   县级以上人民政府应当加强中医药文化宣传,普及中医药知识,鼓励组织和个人创作中医药文化和科普作品。

Article 45 People's governments at the county level or above shall strengthen the publicity of TCM culture, popularize TCM knowledge, and encourage organizations and individuals to create works on TCM culture and science.

第四十六条   开展中医药文化宣传和知识普及活动,应当遵守国家有关规定。任何组织或者个人不得对中医药作虚假、夸大宣传,不得冒用中医药名义牟取不正当利益。

Article 46 TCM culture publicity and knowledge popularization shall comply with the relevant national provisions. No organization or individual may make false or exaggerated publicity or seek improper benefits in the name of TCM.

广播、电视、报刊、互联网等媒体开展中医药知识宣传,应当聘请中医药专业技术人员进行。

Where knowledge on TCM is to be publicized via any medium, such as radio, TV, journal or the internet, TCM professionals shall be employed to do so.

第七章 保障措施

Chapter 7 Guarantee Measures

第四十七条   县级以上人民政府应当为中医药事业发展提供政策支持和条件保障,将中医药事业发展经费纳入本级财政预算。

Article 47 People's governments at the county level or above shall provide supporting policies and conditions for the development of the TCM undertaking, and include the expenses on the development of the TCM undertaking in the financial budget at the corresponding level.

县级以上人民政府及其有关部门制定基本医疗保险支付政策、药物政策等医药卫生政策,应当有中医药主管部门参加,注重发挥中医药的优势,支持提供和利用中医药服务。

The people's governments at the county level or above, and the relevant departments thereunder, shall formulate medicine and health policies, such as the policy on payment of basic medical insurance and the drug policy, with the participation of competent TCM departments, and give play to the advantages of TCM to support the provision and utilization of TCM services.

第四十八条   县级以上人民政府及其有关部门应当按照法定价格管理权限,合理确定中医医疗服务的收费项目和标准,体现中医医疗服务成本和专业技术价值。

Article 48 The people's governments at the county level or above and their departments concerned shall reasonably determine the charging items and standards for TCM medical services in light of their statutory price management authority, so as to reflect the cost and professional and technical value of TCM medical services.

第四十九条   县级以上地方人民政府有关部门应当按照国家规定,将符合条件的中医医疗机构纳入基本医疗保险定点医疗机构范围,将符合条件的中医诊疗项目、中药饮片、中成药和医疗机构中药制剂纳入基本医疗保险基金支付范围。

Article 49 Relevant departments under the local people's governments at the county level or above shall, in accordance with the national policies, include the eligible TCM medical institutions in the scope of designated medical institutions covered by the basic medical insurance and the eligible TCM diagnosis and treatment items, Chinese herbal pieces, traditional Chinese patent medicines and the TCM preparations of medical institutions in the payment scope of the basic medical insurance funds.

第五十条   国家加强中医药标准体系建设,根据中医药特点对需要统一的技术要求制定标准并及时修订。

Article 50 The State will enhance the development of the standard TCM system and formulate and revise from time to time standards for technological requirements that need to be unified according to the characteristics of TCM.

中医药国家标准、行业标准由国务院有关部门依据职责制定或者修订,并在其网站上公布,供公众免费查阅。

Relevant departments under the State Council shall, according to their responsibilities, formulate or revise and issue national standards or industrial standards for TCM on their websites for reference by the public free of charge.

国家推动建立中医药国际标准体系。

The State promotes the establishment of an international standard system for TCM.

第五十一条   开展法律、行政法规规定的与中医药有关的评审、评估、鉴定活动,应当成立中医药评审、评估、鉴定的专门组织,或者有中医药专家参加。

Article 51 Special organizations for reviewing, evaluating and identifying TCM shall be established for, or TCM experts shall participate in, the review, evaluation and identification concerning TCM as stipulated in laws and administrative regulations.

第五十二条   国家采取措施,加大对少数民族医药传承创新、应用发展和人才培养的扶持力度,加强少数民族医疗机构和医师队伍建设,促进和规范少数民族医药事业发展。

Article 52 The State will take measures to intensify the support for the inheritance, innovation, application development and personnel training for the medicines of ethnic minorities, and strengthen the construction of medical institutions and doctor teams of ethnic minorities to promote and regulate the development of the undertaking of the medicines thereof.

第八章 法律责任

Chapter 8 Legal Liabilities

第五十三条   县级以上人民政府中医药主管部门及其他有关部门未履行本法规定的职责的,由本级人民政府或者上级人民政府有关部门责令改正;情节严重的,对直接负责的主管人员和其他直接责任人员,依法给予处分。

Article 53 Where the competent TCM department under a people's government at the county level or above, or another relevant department fails to perform the duties as stipulated in the Law, the people's government at corresponding or higher level shall order it to make corrections; in the case of gross violation, the directly responsible supervisor and other directly liable persons shall be subject to sanctions in accordance with the law.

第五十四条   违反本法规定,中医诊所超出备案范围开展医疗活动的,由所在地县级人民政府中医药主管部门责令改正,没收违法所得,并处一万元以上三万元以下罚款;情节严重的,责令停止执业活动。

Article 54 Where a TCM clinic conducts medical treatment activities beyond its scope as filed in violation of the Law, the competent TCM department under the people's government at the county level of the place where the clinic is located shall order it for correction, confiscate its illegal gains and impose a fine of not less than CNY10,000 but not more than CNY30,000; in the case of gross violation, the clinic shall be ordered to cease its practicing activities.

中医诊所被责令停止执业活动的,其直接负责的主管人员自处罚决定作出之日起五年内不得在医疗机构内从事管理工作。医疗机构聘用上述不得从事管理工作的人员从事管理工作的,由原发证部门吊销执业许可证或者由原备案部门责令停止执业活动。

Where a TCM clinic is ordered to cease its practicing activities, the person in direct charge of the clinic shall, within five years of the date on which the punishment decision is made, not engage in administration in any medical institution. If a medical institution employs such person to engage in administration, the original certificate issuance department shall revoke the practice license or the original record-filing department shall order it to cease its practicing activities.

第五十五条   违反本法规定,经考核取得医师资格的中医医师超出注册的执业范围从事医疗活动的,由县级以上人民政府中医药主管部门责令暂停六个月以上一年以下执业活动,并处一万元以上三万元以下罚款;情节严重的,吊销执业证书。

Article 55 Where a TCM physician obtaining the corresponding qualification upon assessment engages in medical treatment activities beyond the practice scope as registered in violation of the Law, the competent TCM department under the people's government at the county level or above shall order him/her to suspend his/her practicing activities for no less than six months but no more than one year and impose a fine of not less than CNY10,000 but not more than CNY30,000; in the case of gross violation, the practice certificate shall be revoked.

第五十六条   违反本法规定,举办中医诊所、炮制中药饮片、委托配制中药制剂应当备案而未备案,或者备案时提供虚假材料的,由中医药主管部门和药品监督管理部门按照各自职责分工责令改正,没收违法所得,并处三万元以下罚款,向社会公告相关信息;拒不改正的,责令停止执业活动或者责令停止炮制中药饮片、委托配制中药制剂活动,其直接责任人员五年内不得从事中医药相关活动。

Article 56 Where an organization or individual, in violation of this Law, establishes a traditional Chinese medicine clinic, processes prepared slices of Chinese crude drugs, or entrusts others to dispense traditional Chinese medicine preparations without filing for record, or provides false materials when filing for record, traditional Chinese medicine authorities and drug regulators shall, based on their respective duties, order it to make corrections, confiscate its illegal gains, and impose a fine of not more than 30,000 yuan, and shall make public the relevant information. Where the offender refuses to correct, it shall be ordered to suspend professional activities, or to stop processing slices of Chinese crude drugs, or entrusting others to dispense traditional Chinese medicine preparations, and the person in charge directly liable therefor shall not engage in any traditional Chinese medicine- related activities within five years.

医疗机构应用传统工艺配制中药制剂未依照本法规定备案,或者未按照备案材料载明的要求配制中药制剂的,按生产假药给予处罚。

Where a medical institution applies traditional techniques to prepare TCM preparations and fails to perform the record-filing in accordance with the Law, or fails to prepare a TCM preparation in accordance with the requirements specified by the filed materials, the medical institution will be punished as the production of counterfeit drugs.

第五十七条   违反本法规定,发布的中医医疗广告内容与经审查批准的内容不相符的,由原审查部门撤销该广告的审查批准文件,一年内不受理该医疗机构的广告审查申请。

Article 57 Where a medical institution releases a TCM medical advertisement with content inconsistent with that approved upon review in violation of the Law, the original review department shall revoke the review and approval document in relation to the advertisement and not accept any application for review of advertisements filed by the medical institution within one year.

违反本法规定,发布中医医疗广告有前款规定以外违法行为的,依照《中华人民共和国广告法》的规定给予处罚。

Any medical institution which commits any illegal acts other than the act specified in the preceding paragraph in violation of this Law when publishing a TCM medical advertisement shall be punished in accordance with the Advertising Law of the People's Republic of China.

第五十八条   违反本法规定,在中药材种植过程中使用剧毒、高毒农药的,依照有关法律、法规规定给予处罚;情节严重的,可以由公安机关对其直接负责的主管人员和其他直接责任人员处五日以上十五日以下拘留。

Article 58 Where extremely toxic or highly toxic pesticides are used on a CHM plantation, a punishment will be imposed according to the relevant laws and regulations; if the circumstances are serious, the person directly in charge and other persons directly liable will be detained by the public security organ for not less than five days but not more than 15 days.

第五十九条   违反本法规定,造成人身、财产损害的,依法承担民事责任;构成犯罪的,依法追究刑事责任。

Article 59 Whoever violates this Law and thereby causes any personal or property damage shall bear civil liability in accordance with the law; and shall be subject to criminal liability in accordance with the law if the violation constitutes a crime.

第九章

Chapter 9 Supplementary Provisions

第六十条   中医药的管理,本法未作规定的,适用《中华人民共和国执业医师法》、《中华人民共和国药品管理法》等相关法律、行政法规的规定。

Article 60 For matters on TCM administration not covered herein, the Law of the People's Republic of China on Medical Practitioners, the Drug Administration Law of the People's Republic of China and other relevant laws and administrative regulations shall apply.

军队的中医药管理,由军队卫生主管部门依照本法和军队有关规定组织实施。

TCM administration applicable to the army shall be organized and implemented in accordance with the Law and the relevant provisions of the army by competent army health departments.

第六十一条   民族自治地方可以根据《中华人民共和国民族区域自治法》和本法的有关规定,结合实际,制定促进和规范本地方少数民族医药事业发展的办法。

Article 61 Ethnic autonomous areas may, in accordance with the Law of the People's Republic of China on Regional Ethnic Autonomy and the Law, formulate measures to promote and regulate the development of the TCM undertaking of ethnic minorities in their respective areas in light of their actual conditions.

第六十二条   盲人按照国家有关规定取得盲人医疗按摩人员资格的,可以以个人开业的方式或者在医疗机构内提供医疗按摩服务。

Article 62 A blind person who has acquired the qualification for blind medical massage workers may provide medical massage services either in his own clinic or in a medical institution.

第六十三条   本法自201771日起施行。

Article 63 This Law shall come into force as of July 1, 2017.

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