中華人民共和國中醫藥法(中英文對照版)
《中華人民共和國中醫藥法》已由中華人民共和國第十二屆全國人民代表大會常務委員會第二十五次會議於2016年12月25日通過,現予公布,自2017年7月1日起施行。
法律文本
中華人民共和國中醫藥法
Laws of the PRC on Traditional Chinese Medicine
主席令第五十九號
Presidential Decree No. 59
《中華人民共和國中醫藥法》已由中華人民共和國第十二屆全國人民代表大會常務委員會第二十五次會議於2016年12月25日通過,現予公布,自2017年7月1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.
中華人民共和國主席 習近平
President Xi Jinping
2016年12月25日
December 25, 2016
(2016年12月25日第十二屆全國人民代表大會常務委員會第二十五次會議通過)
(Adopted at the 25th Session of the Standing Committee of the 12th National People's Congress on December 25, 2016)
第一章 總 則
Chapter 1 General Provisions
第一條 為了繼承和弘揚中醫藥,保障和促進中醫藥事業發展,保護人民健康,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.
第二條 本法所稱中醫藥,是包括漢族和少數民族醫藥在內的我國各民族醫藥的統稱,是反映中華民族對生命、健康和疾病的認識,具有悠久曆史傳統和獨特理論及技術方法的醫藥學體系。
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.
第三條 中醫藥事業是我國醫藥衛生事業的重要組成部分。國家大力發展中醫藥事業,實行中西醫並重的方針,建立符合中醫藥特點的管理制度,充分發揮中醫藥在我國醫藥衛生事業中的作用。
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.
發展中醫藥事業應當遵循中醫藥發展規律,堅持繼承和創新相結合,保持和發揮中醫藥特色和優勢,運用現代科學技術,促進中醫藥理論和實踐的發展。
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.
國家鼓勵中醫西醫相互學習,相互補充,協調發展,發揮各自優勢,促進中西醫結合。
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.
第四條 縣級以上人民政府應當將中醫藥事業納入國民經濟和社會發展規劃,建立健全中醫藥管理體系,統籌推進中醫藥事業發展。
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.
第五條 國務院中醫藥主管部門負責全國的中醫藥管理工作。國務院其他有關部門在各自職責範圍內負責與中醫藥管理有關的工作。
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.
縣級以上地方人民政府中醫藥主管部門負責本行政區域的中醫藥管理工作。縣級以上地方人民政府其他有關部門在各自職責範圍內負責與中醫藥管理有關的工作。
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.
第六條 國家加強中醫藥服務體系建設,合理規劃和配置中醫藥服務資源,為公民獲得中醫藥服務提供保障。
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.
國家支持社會力量投資中醫藥事業,支持組織和個人捐贈、資助中醫藥事業。
The State supports private capitals to invest in the TCM undertaking, and supports organizations and individuals to donate to and fund the TCM undertaking.
第七條 國家發展中醫藥教育,建立適應中醫藥事業發展需要、規模適宜、結構合理、形式多樣的中醫藥教育體系,培養中醫藥人才。
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.
第八條 國家支持中醫藥科學研究和技術開發,鼓勵中醫藥科學技術創新,推廣應用中醫藥科學技術成果,保護中醫藥知識產權,提高中醫藥科學技術水平。
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.
第九條 國家支持中醫藥對外交流與合作,促進中醫藥的國際傳播和應用。
Article 9 The State supports foreign exchange and cooperation in regard to TCM to promote the dissemination and application of TCM internationally.
第十條 對在中醫藥事業中做出突出貢獻的組織和個人,按照國家有關規定給予表彰、獎勵。
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 中醫藥服務
Chapter 2 TCM Services
第十一條 縣級以上人民政府應當將中醫醫療機構建設納入醫療機構設置規劃,舉辦規模適宜的中醫醫療機構,扶持有中醫藥特色和優勢的醫療機構發展。
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.
合並、撤銷政府舉辦的中醫醫療機構或者改變其中醫醫療性質,應當征求上一級人民政府中醫藥主管部門的意見。
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.
第十二條 政府舉辦的綜合醫院、婦幼保健機構和有條件的專科醫院、社區衛生服務中心、鄉鎮衛生院,應當設置中醫藥科室。
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.
縣級以上人民政府應當采取措施,增強社區衛生服務站和村衛生室提供中醫藥服務的能力。
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.
第十三條 國家支持社會力量舉辦中醫醫療機構。
Article 13 The State supports the establishment of TCM medical institutions with private capital.
社會力量舉辦的中醫醫療機構在準入、執業、基本醫療保險、科研教學、醫務人員職稱評定等方面享有與政府舉辦的中醫醫療機構同等的權利。
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.
第十四條 舉辦中醫醫療機構應當按照國家有關醫療機構管理的規定辦理審批手續,並遵守醫療機構管理的有關規定。
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.
舉辦中醫診所的,將診所的名稱、地址、診療範圍、人員配備情況等報所在地縣級人民政府中醫藥主管部門備案後即可開展執業活動。中醫診所應當將本診所的診療範圍、中醫醫師的姓名及其執業範圍在診所的明顯位置公示,不得超出備案範圍開展醫療活動。具體辦法由國務院中醫藥主管部門擬訂,報國務院衛生行政部門審核、發布。
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.
第十五條 從事中醫醫療活動的人員應當依照《中華人民共和國執業醫師法》的規定,通過中醫醫師資格考試取得中醫醫師資格,並進行執業注冊。中醫醫師資格考試的內容應當體現中醫藥特點。
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.
以師承方式學習中醫或者經多年實踐,醫術確有專長的人員,由至少兩名中醫醫師推薦,經省、自治區、直轄市人民政府中醫藥主管部門組織實踐技能和效果考核合格後,即可取得中醫醫師資格;按照考核內容進行執業注冊後,即可在注冊的執業範圍內,以個人開業的方式或者在醫療機構內從事中醫醫療活動。國務院中醫藥主管部門應當根據中醫藥技術方法的安全風險擬訂本款規定人員的分類考核辦法,報國務院衛生行政部門審核、發布。
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.
第十六條 中醫醫療機構配備醫務人員應當以中醫藥專業技術人員為主,主要提供中醫藥服務;經考試取得醫師資格的中醫醫師按照國家有關規定,經培訓、考核合格後,可以在執業活動中采用與其專業相關的現代科學技術方法。在醫療活動中采用現代科學技術方法的,應當有利於保持和發揮中醫藥特色和優勢。
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.
社區衛生服務中心、鄉鎮衛生院、社區衛生服務站以及有條件的村衛生室應當合理配備中醫藥專業技術人員,並運用和推廣適宜的中醫藥技術方法。
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.
第十七條 開展中醫藥服務,應當以中醫藥理論為指導,運用中醫藥技術方法,並符合國務院中醫藥主管部門制定的中醫藥服務基本要求。
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.
第十八條 縣級以上人民政府應當發展中醫藥預防、保健服務,並按照國家有關規定將其納入基本公共衛生服務項目統籌實施。
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.
縣級以上人民政府應當發揮中醫藥在突發公共衛生事件應急工作中的作用,加強中醫藥應急物資、設備、設施、技術與人才資源儲備。
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.
醫療衛生機構應當在疾病預防與控制中積極運用中醫藥理論和技術方法。
Medical and health institutions shall apply TCM theories and technical methods actively in disease prevention and control.
第十九條 醫療機構發布中醫醫療廣告,應當經所在地省、自治區、直轄市人民政府中醫藥主管部門審查批準;未經審查批準,不得發布。發布的中醫醫療廣告內容應當與經審查批準的內容相符合,並符合《中華人民共和國廣告法》的有關規定。
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.
第二十條 縣級以上人民政府中醫藥主管部門應當加強對中醫藥服務的監督檢查,並將下列事項作為監督檢查的重點:
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)中醫醫療機構、中醫醫師是否超出規定的範圍開展醫療活動;
1. whether a TCM medical institution or a TCM physician carries out medical treatment activities beyond the scope as prescribed;
(二)開展中醫藥服務是否符合國務院中醫藥主管部門制定的中醫藥服務基本要求;
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)中醫醫療廣告發布行為是否符合本法的規定。
3. whether the publishing of TCM advertisements meets the provisions hereof.
中醫藥主管部門依法開展監督檢查,有關單位和個人應當予以配合,不得拒絕或者阻撓。
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 中藥保護與發展
Chapter 3 Protection and Development of CHMs
第二十一條 國家制定中藥材種植養殖、采集、貯存和初加工的技術規範、標準,加強對中藥材生產流通全過程的質量監督管理,保障中藥材質量安全。
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.
第二十二條 國家鼓勵發展中藥材規範化種植養殖,嚴格管理農藥、肥料等農業投入品的使用,禁止在中藥材種植過程中使用劇毒、高毒農藥,支持中藥材良種繁育,提高中藥材質量。
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.
第二十三條 國家建立道地中藥材評價體系,支持道地中藥材品種選育,扶持道地中藥材生產基地建設,加強道地中藥材生產基地生態環境保護,鼓勵采取地理標志產品保護等措施保護道地中藥材。
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.
前款所稱道地中藥材,是指經過中醫臨床長期應用優選出來的,產在特定地域,與其他地區所產同種中藥材相比,品質和療效更好,且質量穩定,具有較高知名度的中藥材。
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.
第二十四條 國務院藥品監督管理部門應當組織並加強對中藥材質量的監測,定期向社會公布監測結果。國務院有關部門應當協助做好中藥材質量監測有關工作。
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、貯存中藥材以及對中藥材進行初加工,應當符合國家有關技術規範、標準和管理規定。
The collection, storage and preliminary processing of CHMs shall comply with the relevant national technical specifications, standards and administrative provisions.
國家鼓勵發展中藥材現代流通體系,提高中藥材包裝、倉儲等技術水平,建立中藥材流通追溯體系。藥品生產企業購進中藥材應當建立進貨查驗記錄制度。中藥材經營者應當建立進貨查驗和購銷記錄制度,並標明中藥材產地。
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.
第二十五條 國家保護藥用野生動植物資源,對藥用野生動植物資源實行動態監測和定期普查,建立藥用野生動植物資源種質基因庫,鼓勵發展人工種植養殖,支持依法開展珍貴、瀕危藥用野生動植物的保護、繁育及其相關研究。
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.
第二十六條 在村醫療機構執業的中醫醫師、具備中藥材知識和識別能力的鄉村醫生,按照國家有關規定可以自種、自采地產中藥材並在其執業活動中使用。
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.
第二十七條 國家保護中藥飲片傳統炮制技術和工藝,支持應用傳統工藝炮制中藥飲片,鼓勵運用現代科學技術開展中藥飲片炮制技術研究。
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.
第二十八條 對市場上沒有供應的中藥飲片,醫療機構可以根據本醫療機構醫師處方的需要,在本醫療機構內炮制、使用。醫療機構應當遵守中藥飲片炮制的有關規定,對其炮制的中藥飲片的質量負責,保證藥品安全。醫療機構炮制中藥飲片,應當向所在地設區的市級人民政府藥品監督管理部門備案。
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.
根據臨床用藥需要,醫療機構可以憑本醫療機構醫師的處方對中藥飲片進行再加工。
A medical institution may reprocess Chinese herbal pieces by virtue of prescriptions issued by its physicians to satisfy its needs in clinical medication.
第二十九條 國家鼓勵和支持中藥新藥的研制和生產。
Article 29 The State encourages and supports the research, development and production of new CHMs.
國家保護傳統中藥加工技術和工藝,支持傳統劑型中成藥的生產,鼓勵運用現代科學技術研究開發傳統中成藥。
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.
第三十條 生產符合國家規定條件的來源於古代經典名方的中藥複方制劑,在申請藥品批準文號時,可以僅提供非臨床安全性研究資料。具體管理辦法由國務院藥品監督管理部門會同中醫藥主管部門制定。
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.
前款所稱古代經典名方,是指至今仍廣泛應用、療效確切、具有明顯特色與優勢的古代中醫典籍所記載的方劑。具體目錄由國務院中醫藥主管部門會同藥品監督管理部門制定。
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.
第三十一條 國家鼓勵醫療機構根據本醫療機構臨床用藥需要配制和使用中藥制劑,支持應用傳統工藝配制中藥制劑,支持以中藥制劑為基礎研制中藥新藥。
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.
醫療機構配制中藥制劑,應當依照《中華人民共和國藥品管理法》的規定取得醫療機構制劑許可證,或者委托取得藥品生產許可證的藥品生產企業、取得醫療機構制劑許可證的其他醫療機構配制中藥制劑。委托配制中藥制劑,應當向委托方所在地省、自治區、直轄市人民政府藥品監督管理部門備案。
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.
醫療機構對其配制的中藥制劑的質量負責;委托配制中藥制劑的,委托方和受托方對所配制的中藥制劑的質量分別承擔相應責任。
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.
第三十二條 醫療機構配制的中藥制劑品種,應當依法取得制劑批準文號。但是,僅應用傳統工藝配制的中藥制劑品種,向醫療機構所在地省、自治區、直轄市人民政府藥品監督管理部門備案後即可配制,不需要取得制劑批準文號。
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.
醫療機構應當加強對備案的中藥制劑品種的不良反應監測,並按照國家有關規定進行報告。藥品監督管理部門應當加強對備案的中藥制劑品種配制、使用的監督檢查。
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 中醫藥人才培養
Chapter 4 Training of TCM Personnel
第三十三條 中醫藥教育應當遵循中醫藥人才成長規律,以中醫藥內容為主,體現中醫藥文化特色,注重中醫藥經典理論和中醫藥臨床實踐、現代教育方式和傳統教育方式相結合。
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.
第三十四條 國家完善中醫藥學校教育體系,支持專門實施中醫藥教育的高等學校、中等職業學校和其他教育機構的發展。
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.
中醫藥學校教育的培養目標、修業年限、教學形式、教學內容、教學評價及學術水平評價標準等,應當體現中醫藥學科特色,符合中醫藥學科發展規律。
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.
第三十五條 國家發展中醫藥師承教育,支持有豐富臨床經驗和技術專長的中醫醫師、中藥專業技術人員在執業、業務活動中帶徒授業,傳授中醫藥理論和技術方法,培養中醫藥專業技術人員。
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.
第三十六條 國家加強對中醫醫師和城鄉基層中醫藥專業技術人員的培養和培訓。
Article 36 The State strengthens the cultivation and training for TCM physicians and TCM professionals at grassroots level in urban and rural areas.
國家發展中西醫結合教育,培養高層次的中西醫結合人才。
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.
第三十七條 縣級以上地方人民政府中醫藥主管部門應當組織開展中醫藥繼續教育,加強對醫務人員,特別是城鄉基層醫務人員中醫藥基本知識和技能的培訓。
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.
中醫藥專業技術人員應當按照規定參加繼續教育,所在機構應當為其接受繼續教育創造條件。
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 中醫藥科學研究
Chapter 5 Research on TCM Science
第三十八條 國家鼓勵科研機構、高等學校、醫療機構和藥品生產企業等,運用現代科學技術和傳統中醫藥研究方法,開展中醫藥科學研究,加強中西醫結合研究,促進中醫藥理論和技術方法的繼承和創新。
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.
第三十九條 國家采取措施支持對中醫藥古籍文獻、著名中醫藥專家的學術思想和診療經驗以及民間中醫藥技術方法的整理、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.
國家鼓勵組織和個人捐獻有科學研究和臨床應用價值的中醫藥文獻、秘方、驗方、診療方法和技術。
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.
第四十條 國家建立和完善符合中醫藥特點的科學技術創新體系、評價體系和管理體制,推動中醫藥科學技術進步與創新。
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.
第四十一條 國家采取措施,加強對中醫藥基礎理論和辨證論治方法,常見病、多發病、慢性病和重大疑難疾病、重大傳染病的中醫藥防治,以及其他對中醫藥理論和實踐發展有重大促進作用的項目的科學研究。
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 中醫藥傳承與文化傳播
Chapter 6 Traditional Chinese Medicine Inheritance and Cultural Communication
第四十二條 對具有重要學術價值的中醫藥理論和技術方法,省級以上人民政府中醫藥主管部門應當組織遴選本行政區域內的中醫藥學術傳承項目和傳承人,並為傳承活動提供必要的條件。傳承人應當開展傳承活動,培養後繼人才,收集整理並妥善保存相關的學術資料。屬於非物質文化遺產代表性項目的,依照《中華人民共和國非物質文化遺產法》的有關規定開展傳承活動。
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.
第四十三條 國家建立中醫藥傳統知識保護數據庫、保護名錄和保護制度。
Article 43 The State establishes the protection database, protection catalogue and protection system for traditional TCM knowledge.
中醫藥傳統知識持有人對其持有的中醫藥傳統知識享有傳承使用的權利,對他人獲取、利用其持有的中醫藥傳統知識享有知情同意和利益分享等權利。
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.
國家對經依法認定屬於國家秘密的傳統中藥處方組成和生產工藝實行特殊保護。
The State exercises special protection of the composition and production process of TCM prescriptions that are legally recognized as national secrets.
第四十四條 國家發展中醫養生保健服務,支持社會力量舉辦規範的中醫養生保健機構。中醫養生保健服務規範、標準由國務院中醫藥主管部門制定。
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.
第四十五條 縣級以上人民政府應當加強中醫藥文化宣傳,普及中醫藥知識,鼓勵組織和個人創作中醫藥文化和科普作品。
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.
第四十六條 開展中醫藥文化宣傳和知識普及活動,應當遵守國家有關規定。任何組織或者個人不得對中醫藥作虛假、誇大宣傳,不得冒用中醫藥名義牟取不正當利益。
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.
廣播、電視、報刊、互聯網等媒體開展中醫藥知識宣傳,應當聘請中醫藥專業技術人員進行。
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
第四十七條 縣級以上人民政府應當為中醫藥事業發展提供政策支持和條件保障,將中醫藥事業發展經費納入本級財政預算。
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.
縣級以上人民政府及其有關部門制定基本醫療保險支付政策、藥物政策等醫藥衛生政策,應當有中醫藥主管部門參加,注重發揮中醫藥的優勢,支持提供和利用中醫藥服務。
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.
第四十八條 縣級以上人民政府及其有關部門應當按照法定價格管理權限,合理確定中醫醫療服務的收費項目和標準,體現中醫醫療服務成本和專業技術價值。
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.
第四十九條 縣級以上地方人民政府有關部門應當按照國家規定,將符合條件的中醫醫療機構納入基本醫療保險定點醫療機構範圍,將符合條件的中醫診療項目、中藥飲片、中成藥和醫療機構中藥制劑納入基本醫療保險基金支付範圍。
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.
第五十條 國家加強中醫藥標準體系建設,根據中醫藥特點對需要統一的技術要求制定標準並及時修訂。
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.
中醫藥國家標準、行業標準由國務院有關部門依據職責制定或者修訂,並在其網站上公布,供公眾免費查閱。
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.
國家推動建立中醫藥國際標準體系。
The State promotes the establishment of an international standard system for TCM.
第五十一條 開展法律、行政法規規定的與中醫藥有關的評審、評估、鑒定活動,應當成立中醫藥評審、評估、鑒定的專門組織,或者有中醫藥專家參加。
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.
第五十二條 國家采取措施,加大對少數民族醫藥傳承創新、應用發展和人才培養的扶持力度,加強少數民族醫療機構和醫師隊伍建設,促進和規範少數民族醫藥事業發展。
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 法律責任
Chapter 8 Legal Liabilities
第五十三條 縣級以上人民政府中醫藥主管部門及其他有關部門未履行本法規定的職責的,由本級人民政府或者上級人民政府有關部門責令改正;情節嚴重的,對直接負責的主管人員和其他直接責任人員,依法給予處分。
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.
第五十四條 違反本法規定,中醫診所超出備案範圍開展醫療活動的,由所在地縣級人民政府中醫藥主管部門責令改正,沒收違法所得,並處一萬元以上三萬元以下罰款;情節嚴重的,責令停止執業活動。
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.
中醫診所被責令停止執業活動的,其直接負責的主管人員自處罰決定作出之日起五年內不得在醫療機構內從事管理工作。醫療機構聘用上述不得從事管理工作的人員從事管理工作的,由原發證部門吊銷執業許可證或者由原備案部門責令停止執業活動。
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.
第五十五條 違反本法規定,經考核取得醫師資格的中醫醫師超出注冊的執業範圍從事醫療活動的,由縣級以上人民政府中醫藥主管部門責令暫停六個月以上一年以下執業活動,並處一萬元以上三萬元以下罰款;情節嚴重的,吊銷執業證書。
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.
第五十六條 違反本法規定,舉辦中醫診所、炮制中藥飲片、委托配制中藥制劑應當備案而未備案,或者備案時提供虛假材料的,由中醫藥主管部門和藥品監督管理部門按照各自職責分工責令改正,沒收違法所得,並處三萬元以下罰款,向社會公告相關信息;拒不改正的,責令停止執業活動或者責令停止炮制中藥飲片、委托配制中藥制劑活動,其直接責任人員五年內不得從事中醫藥相關活動。
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.
醫療機構應用傳統工藝配制中藥制劑未依照本法規定備案,或者未按照備案材料載明的要求配制中藥制劑的,按生產假藥給予處罰。
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.
第五十七條 違反本法規定,發布的中醫醫療廣告內容與經審查批準的內容不相符的,由原審查部門撤銷該廣告的審查批準文件,一年內不受理該醫療機構的廣告審查申請。
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.
違反本法規定,發布中醫醫療廣告有前款規定以外違法行為的,依照《中華人民共和國廣告法》的規定給予處罰。
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.
第五十八條 違反本法規定,在中藥材種植過程中使用劇毒、高毒農藥的,依照有關法律、法規規定給予處罰;情節嚴重的,可以由公安機關對其直接負責的主管人員和其他直接責任人員處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.
第五十九條 違反本法規定,造成人身、財產損害的,依法承擔民事責任;構成犯罪的,依法追究刑事責任。
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 附 則
Chapter 9 Supplementary Provisions
第六十條 中醫藥的管理,本法未作規定的,適用《中華人民共和國執業醫師法》、《中華人民共和國藥品管理法》等相關法律、行政法規的規定。
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.
軍隊的中醫藥管理,由軍隊衛生主管部門依照本法和軍隊有關規定組織實施。
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.
第六十一條 民族自治地方可以根據《中華人民共和國民族區域自治法》和本法的有關規定,結合實際,制定促進和規範本地方少數民族醫藥事業發展的辦法。
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.
第六十二條 盲人按照國家有關規定取得盲人醫療按摩人員資格的,可以以個人開業的方式或者在醫療機構內提供醫療按摩服務。
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.
第六十三條 本法自2017年7月1日起施行。
Article 63 This Law shall come into force as of July 1, 2017.
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