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Medicinal Product Administration Law of the People's Republic of China (2019 Revision) [Effective]
中华人民共和国药品管理法(2019修订) [现行有效]
【法宝引证码】

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

中华人民共和国主席令

(No. 31) (第三十一号)

The Medicinal Product Administration Law of the People's Republic of China, as revised and adopted at the 12th Session of the Standing Committee of the Thirteenth National People's Congress of the People's Republic of China on August 26, 2019, is hereby issued, and shall come into force on December 1, 2019. 《中华人民共和国药品管理法》已由中华人民共和国第十三届全国人民代表大会常务委员会第十二次会议于2019年8月26日修订通过,现予公布,自2019年12月1日起施行。
Xi Jinping, President of the People's Republic of China 中华人民共和国主席 习近平
August 26, 2019 2019年8月26日
Medicinal Product Administration Law of the People's Republic of China 中华人民共和国药品管理法
(Adopted at the 7th Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984; revised for the first time at the 20th Session of the Ninth National People's Congress on February 28, 2001; amended for the first time in accordance with the Decision to Amend Seven Laws Including the Marine Environment Protection Law of the People's Republic of China at the 6th Session of the Standing Committee of the Twelfth National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision to Amend the Medicinal Product Administration Law of the People's Republic of China at the 14th Session of the Standing Committee of the Twelfth National People's Congress of the People's Republic of China on April 24, 2015; and revised for the second time at the 12th Session of the Standing Committee of the Thirteenth National People's Congress on August 26, 2019) (1984年9月20日第六届全国人民代表大会常务委员会第七次会议通过 2001年2月28日第九届全国人民代表大会常务委员会第二十次会议第一次修订 根据2013年12月28日第十二届全国人民代表大会常务委员会第六次会议《关于修改〈中华人民共和国海洋环境保护法〉等七部法律的决定》第一次修正 根据2015年4月24日第十二届全国人民代表大会常务委员会第十四次会议《关于修改〈中华人民共和国药品管理法〉的决定》第二次修正 2019年8月26日第十三届全国人民代表大会常务委员会第十二次会议第二次修订)
Contents 目  录
Chapter I General Provisions 第一章 总  则
Chapter II Research, Development, and Registration of Medicinal Products 第二章 药品研制和注册
Chapter III Holders of Marketing Authorization for Medicinal Products 第三章 药品上市许可持有人
Chapter IV Manufacture of Medicinal Products 第四章 药品生产
Chapter V Distribution of Medicinal Products 第五章 药品经营
Chapter VI Pharmaceutical Affairs Management of Medical Institutions 第六章 医疗机构药事管理
Chapter VII Post-market Management of Medicinal Products 第七章 药品上市后管理
Chapter VIII Prices and Advertising of Medicinal Products 第八章 药品价格和广告
Chapter IX Reserves and Supply of Medicinal Products 第九章 药品储备和供应
Chapter X Supervision and Administration 第十章 监督管理
Chapter XI Legal Liability 第十一章 法律责任
Chapter XII Supplemental Provisions 第十二章 附  则
Chapter I General Provisions 

第一章 总  则

Article 1 This Law is enacted for the purposes of enhancing medicinal product administration, ensuring medicinal product quality, maintaining the medication safety and lawful rights and interests of the public, and protecting and promoting public health.   第一条 为了加强药品管理,保证药品质量,保障公众用药安全和合法权益,保护和促进公众健康,制定本法。
Article 2 This Law shall apply to the research, development, manufacturing, distribution, use, supervision, and administration of medicinal products in the territory of the People's Republic of China.   第二条 在中华人民共和国境内从事药品研制、生产、经营、使用和监督管理活动,适用本法。
For the purposes of this Law, “medicinal product” means a substance for the prevention, treatment, or diagnosis of disease in human beings to effect the intended regulation of human physiological functions with the approved therapeutic indications or actions and indications, usage, and dosage, including but not limited to traditional Chinese medicines, chemical medicines, and biological products. 本法所称药品,是指用于预防、治疗、诊断人的疾病,有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质,包括中药、化学药和生物制品等。
Article 3 Medicinal product administration shall center around people's health, adhere to the principles of risk management, whole process management and control, and social co-governance, and by establishment of a scientific and strict regulatory regime, comprehensively improve medicinal product quality, and guarantee the safety, efficacy, and accessibility of medicinal products.   第三条 药品管理应当以人民健康为中心,坚持风险管理、全程管控、社会共治的原则,建立科学、严格的监督管理制度,全面提升药品质量,保障药品的安全、有效、可及。
Article 4 The state shall develop both modern and traditional medicines to maximize their roles in prevention, medical care, and health protection.   第四条 国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。
The state shall protect the natural resources of medicinal materials and the varieties of traditional Chinese medicines, and encourage the cultivation of traditional Chinese medicinal materials of recognized quality and efficacy. 国家保护野生药材资源和中药品种,鼓励培育道地中药材。
Article 5 The state shall encourage the research and invention of new medicinal products, and protect the lawful rights and interests of citizens, legal persons, and other organizations in the research and development of new medicinal products.   第五条 国家鼓励研究和创制新药,保护公民、法人和其他组织研究、开发新药的合法权益。
Article 6 In medicinal product administration, the state shall implement a marketing authorization holder system for medicinal products. Marketing authorization holders shall be responsible for the safety, efficacy, and quality controllability of medicinal products during the whole process of research, development, manufacture, distribution, and use of medicinal products in accordance with the law.   第六条 国家对药品管理实行药品上市许可持有人制度。药品上市许可持有人依法对药品研制、生产、经营、使用全过程中药品的安全性、有效性和质量可控性负责。
Article 7 The research, development, manufacture, distribution, and use of medicinal products shall comply with laws, regulations, rules, standards, and specifications, and the authenticity, accuracy, integrity, and traceability of information during the whole process shall be ensured.   第七条 从事药品研制、生产、经营、使用活动,应当遵守法律、法规、规章、标准和规范,保证全过程信息真实、准确、完整和可追溯。
Article 8 The medicinal product regulatory department of the State Council shall be responsible for the national supervision and administration of medicinal products. The other relevant departments of the State Council shall be responsible for supervision and administration related to medicinal products within their respective functions. The medicinal product regulatory department of the State Council shall cooperate with the relevant departments of the State Council in implementing national general plans for pharmaceutical industry development and industry policies.   第八条 国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自职责范围内负责与药品有关的监督管理工作。国务院药品监督管理部门配合国务院有关部门,执行国家药品行业发展规划和产业政策。
The medicinal product regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government shall be responsible for the supervision and administration of medicinal products within their respective administrative regions. The department of a people's government at or above the districted city or the county level charged with the function of supervision and administration of medicinal products (“medicinal product regulatory department”) shall be responsible for the supervision and administration of medicinal products within its administrative region. The relevant departments of a local people's government at or above the county level shall be responsible for supervision and administration related to medicinal products within their respective functions. 省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。设区的市级、县级人民政府承担药品监督管理职责的部门(以下称药品监督管理部门)负责本行政区域内的药品监督管理工作。县级以上地方人民政府有关部门在各自职责范围内负责与药品有关的监督管理工作。
Article 9 Local people's governments at and above the county level shall be responsible for the supervision and administration of medicinal products within their respective administrative regions, lead, organize, and coordinate in a unified manner the supervision and administration of medicinal products as well as medicinal product safety emergency response work within their respective administrative regions, and establish and improve their supervision and administration working mechanisms and information sharing mechanisms for medicinal products.   第九条 县级以上地方人民政府对本行政区域内的药品监督管理工作负责,统一领导、组织、协调本行政区域内的药品监督管理工作以及药品安全突发事件应对工作,建立健全药品监督管理工作机制和信息共享机制。
Article 10 Local people's governments at and above the county level shall include medicinal product safety work in the national economic and social development plans at their respective levels, list the funding for medicinal product safety work in their respective budgets, strengthen their capacity building for supervision and administration of medicinal products, and provide guarantees for medicinal product safety work.   第十条 县级以上人民政府应当将药品安全工作纳入本级国民经济和社会发展规划,将药品安全工作经费列入本级政府预算,加强药品监督管理能力建设,为药品安全工作提供保障。
Article 11 The specialized technical institutions for medicinal products established or designated by medicinal product regulatory departments shall undertake the evaluation, control, inspection, surveillance, reevaluation, and other work necessary for the implementation of supervision and administration of medicinal products in accordance with the law.   第十一条 药品监督管理部门设置或者指定的药品专业技术机构,承担依法实施药品监督管理所需的审评、检验、核查、监测与评价等工作。
Article 12 The state shall establish and improve a medicinal product traceability system. The medicinal product regulatory department of the State Council shall develop unified medicinal product traceability standards and specifications, advance the interconnection and mutual sharing of medicinal product traceability information, and achieve medicinal product traceability.   第十二条 国家建立健全药品追溯制度。国务院药品监督管理部门应当制定统一的药品追溯标准和规范,推进药品追溯信息互通互享,实现药品可追溯。
The state shall establish a pharmacovigilance system to monitor, identify, assess, and control adverse reactions to medicinal products and other harmful reactions associated with the use of medicinal products. 国家建立药物警戒制度,对药品不良反应及其他与用药有关的有害反应进行监测、识别、评估和控制。
Article 13 The people's governments at all levels and their relevant departments and the pharmaceutical industry associations, among others, shall strengthen publicity and education on medicinal product safety, and widely disseminate medicinal product safety laws and regulations and other knowledge.   第十三条 各级人民政府及其有关部门、药品行业协会等应当加强药品安全宣传教育,开展药品安全法律法规等知识的普及工作。
News media shall, in the public interest, conduct publicity on medicinal product safety laws and regulations and other knowledge, and implement supervision over illegal activities related to medicinal products by public opinion. Publicity and coverage on medicinal products shall be comprehensive, scientific, objective, and fair. 新闻媒体应当开展药品安全法律法规等知识的公益宣传,并对药品违法行为进行舆论监督。有关药品的宣传报道应当全面、科学、客观、公正。
Article 14 Pharmaceutical industry associations shall strengthen industry self-regulation, establish and improve industry norms, advance the building of industry integrity systems, and guide and supervise their members in the lawful manufacture and distribution, among others, of medicinal products.   第十四条 药品行业协会应当加强行业自律,建立健全行业规范,推动行业诚信体系建设,引导和督促会员依法开展药品生产经营等活动。
Article 15 The people's governments at and above the county level and their relevant departments shall, in accordance with the relevant provisions issued by the state, commend and reward entities and individuals which have made outstanding contributions to the research, development, manufacture, distribution, use, supervision, and administration of medicinal products.   第十五条 县级以上人民政府及其有关部门对在药品研制、生产、经营、使用和监督管理工作中做出突出贡献的单位和个人,按照国家有关规定给予表彰、奖励。
Chapter II Research, Development, and Registration of Medicinal Products 

第二章 药品研制和注册

Article 16 The state shall support pharmaceutical innovations oriented to clinical value with clear or special therapeutic effects on human diseases, encourage the research and development of new medicinal products which have new therapeutic mechanisms, treat serious life-threatening diseases or rare diseases, or have multi-target systematic regulation and intervention functions for human body, among others, and promote the advancement of pharmaceutical technology.   第十六条 国家支持以临床价值为导向、对人的疾病具有明确或者特殊疗效的药物创新,鼓励具有新的治疗机理、治疗严重危及生命的疾病或者罕见病、对人体具有多靶向系统性调节干预功能等的新药研制,推动药品技术进步。
The state shall encourage the science and technology research on traditional Chinese medicines and the development of pharmaceuticals by using modern science and technology and traditional research methods for traditional Chinese medicines, establish and improve a technical evaluation system conforming to the characteristics of traditional Chinese medicines, and promote traditional Chinese medicine inheritance and innovation. 国家鼓励运用现代科学技术和传统中药研究方法开展中药科学技术研究和药物开发,建立和完善符合中药特点的技术评价体系,促进中药传承创新。
The state shall adopt effective measures to encourage pediatric medicinal product research, development, and innovation, support the development of new varieties, dosage forms, and specifications of pediatric medicinal products which conform to the physiological characteristics of children, and prioritize the evaluation and approval of pediatric medicinal products. 国家采取有效措施,鼓励儿童用药品的研制和创新,支持开发符合儿童生理特征的儿童用药品新品种、剂型和规格,对儿童用药品予以优先审评审批。
Article 17 The research and development of medicinal products shall comply with the good laboratory practice for nonclinical laboratory studies (“GLP”) for pharmaceuticals and the good clinical practice (“GCP”) for pharmaceuticals, and the continuing compliance with the statutory requirements shall be ensured during the whole process of research and development of medicinal products.   第十七条 从事药品研制活动,应当遵守药物非临床研究质量管理规范药物临床试验质量管理规范,保证药品研制全过程持续符合法定要求。
The GLP and GCP shall be developed by the medicinal product regulatory department of the State Council in conjunction with the relevant departments of the State Council. 药物非临床研究质量管理规范药物临床试验质量管理规范由国务院药品监督管理部门会同国务院有关部门制定。
Article 18 Nonclinical laboratory studies for pharmaceuticals shall be conducted in compliance with the relevant provisions issued by the state, with the personnel, site, equipment, instruments, and management system appropriate for the study project, and the authenticity of the relevant data, information, and samples shall be ensured.   第十八条 开展药物非临床研究,应当符合国家有关规定,有与研究项目相适应的人员、场地、设备、仪器和管理制度,保证有关数据、资料和样品的真实性。
Article 19 To conduct pharmaceutical clinical trials, the research and development methods, quality indicators, results of pharmacological and toxicological tests, and other relevant data, information, and samples shall be truthfully reported in accordance with the rules of the medicinal product regulatory department of the State Council, and be subject to the approval of the medicinal product regulatory department of the State Council. The medicinal product regulatory department of the State Council shall, within 60 working days of accepting an application for a clinical trial, decide whether to grant the application and notify the sponsor, and shall be deemed to have granted the application if the sponsor is not notified within the time limit. Bioequivalence studies, if any, shall be reported to the medicinal product regulatory department of the State Council for recordation.   第十九条 开展药物临床试验,应当按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关数据、资料和样品,经国务院药品监督管理部门批准。国务院药品监督管理部门应当自受理临床试验申请之日起六十个工作日内决定是否同意并通知临床试验申办者,逾期未通知的,视为同意。其中,开展生物等效性试验的,报国务院药品监督管理部门备案。
Pharmaceutical clinical trials shall be conducted in clinical trial institutions which meet the corresponding conditions. Pharmaceutical clinical trial institutions shall be subject to recordation management, and the specific measures shall be developed jointly by the medicinal product regulatory department of the State Council and the health department of the State Council. 开展药物临床试验,应当在具备相应条件的临床试验机构进行。药物临床试验机构实行备案管理,具体办法由国务院药品监督管理部门、国务院卫生健康主管部门共同制定。
Article 20 Pharmaceutical clinical trials shall be conducted in conformity with ethical principles, and clinical trial protocols shall be developed, subject to the review and consent of the ethics committee.   第二十条 开展药物临床试验,应当符合伦理原则,制定临床试验方案,经伦理委员会审查同意。
The ethics committee shall establish a working system of ethical review, ensure that the process of ethical review is independent, objective, and fair, oversee the conduct of pharmaceutical clinical trials in a well-regulated manner, protect the lawful rights and interests of human subjects, and safeguard the public interest. 伦理委员会应当建立伦理审查工作制度,保证伦理审查过程独立、客观、公正,监督规范开展药物临床试验,保障受试者合法权益,维护社会公共利益。
Article 21 In the implementation of pharmaceutical clinical trials, the objectives, risks, and other particulars of clinical trials shall be truthfully stated and explained to human subjects or their guardians, informed consent forms voluntarily signed by human subjects or their guardians shall be obtained, and effective measures shall be adopted to protect the lawful rights and interests of human subjects.   第二十一条 实施药物临床试验,应当向受试者或者其监护人如实说明和解释临床试验的目的和风险等详细情况,取得受试者或者其监护人自愿签署的知情同意书,并采取有效措施保护受试者合法权益。
Article 22 Where any safety issue or other risk is discovered during a pharmaceutical clinical trial, the sponsor of the clinical trial shall, in a timely manner, adjust the clinical trial protocol or suspend or terminate the clinical trial, and report to the medicinal product regulatory department of the State Council. When necessary, the medicinal product regulatory department of the State Council may order adjustment of the clinical trial protocol or suspension or termination of the clinical trial.   第二十二条 药物临床试验期间,发现存在安全性问题或者其他风险的,临床试验申办者应当及时调整临床试验方案、暂停或者终止临床试验,并向国务院药品监督管理部门报告。必要时,国务院药品监督管理部门可以责令调整临床试验方案、暂停或者终止临床试验。
Article 23 Pharmaceuticals in clinical trials intended for the treatment of serious life-threatening diseases for which there is no effective means of treatment may, upon review and informed consent, be administered to patients with the same conditions within the institution conducting the clinical trials, provided that such pharmaceuticals may be beneficial as indicated by medical observation and it is in conformity with ethical principles.   第二十三条 对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的药物,经医学观察可能获益,并且符合伦理原则的,经审查、知情同意后可以在开展临床试验的机构内用于其他病情相同的患者。
Article 24 Medicinal products to be marketed in China shall be subject to the approval of the medicinal product regulatory department of the State Council, and registration certificates shall be obtained for them, except for traditional Chinese medicinal materials and decoction pieces not subject to approval management. The catalogs of traditional Chinese medicinal materials and decoction pieces subject to approval management shall be developed by the medicinal product regulatory department of the State Council in conjunction with the traditional Chinese medicine department of the State Council.   第二十四条 在中国境内上市的药品,应当经国务院药品监督管理部门批准,取得药品注册证书;但是,未实施审批管理的中药材和中药饮片除外。实施审批管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药主管部门制定。
To apply for registration of a medicinal product, the applicant shall provide authentic, sufficient, and reliable data, information, and samples, evidencing the safety, efficacy, and quality controllability of the medicinal product. 申请药品注册,应当提供真实、充分、可靠的数据、资料和样品,证明药品的安全性、有效性和质量可控性。
Article 25 For a medicinal product under an application for registration, the medicinal product regulatory department of the State Council shall arrange for pharmaceutical, medical, and other technical personnel to conduct an evaluation to review the safety, efficacy, and quality controllability of the medicinal product and the applicant's capabilities of quality management, risk prevention and control, and payment of damages, among others; and if the prescribed conditions are met, issue a registration certificate for the medicinal product.   第二十五条 对申请注册的药品,国务院药品监督管理部门应当组织药学、医学和其他技术人员进行审评,对药品的安全性、有效性和质量可控性以及申请人的质量管理、风险防控和责任赔偿等能力进行审查;符合条件的,颁发药品注册证书。
In approving medicinal products, the medicinal product regulatory department of the State Council shall concurrently evaluate and approve chemical active pharmaceutical ingredients (APIs), concurrently evaluate the relevant inactive ingredients and packaging materials and containers immediately in contact with medicinal products, and concurrently review and approve the quality standards, manufacturing processes, labels, and package leaflets of medicinal products. 国务院药品监督管理部门在审批药品时,对化学原料药一并审评审批,对相关辅料、直接接触药品的包装材料和容器一并审评,对药品的质量标准、生产工艺、标签和说明书一并核准。
For the purposes of this Law, “inactive ingredients” means excipients and additives used in the manufacture of medicinal products and the dispensing of prescriptions. 本法所称辅料,是指生产药品和调配处方时所用的赋形剂和附加剂。
Article 26 Medicinal products intended for the treatment of serious life-threatening diseases for which there is no effective means of treatment or urgently needed for public health may be conditionally approved with the relevant matters stated in the registration certificates for them, provided that data from pharmaceutical clinical trials have indicated any therapeutic effects and their clinical values are predictable.   第二十六条 对治疗严重危及生命且尚无有效治疗手段的疾病以及公共卫生方面急需的药品,药物临床试验已有数据显示疗效并能预测其临床价值的,可以附条件批准,并在药品注册证书中载明相关事项。
Article 27 The medicinal product regulatory department of the State Council shall improve the working system of evaluation and approval of medicinal products, strengthen capacity building, establish and improve the communication and exchange, expert advice, and other mechanisms, optimize the processes of evaluation and approval, and raise the efficiency of evaluation and approval.   第二十七条 国务院药品监督管理部门应当完善药品审评审批工作制度,加强能力建设,建立健全沟通交流、专家咨询等机制,优化审评审批流程,提高审评审批效率。
The evaluation conclusion and basis for a medicinal product approved for marketing shall be disclosed to the public in accordance with the law to receive supervision by the public. Trade secrets known during evaluation and approval shall be kept confidential. 批准上市药品的审评结论和依据应当依法公开,接受社会监督。对审评审批中知悉的商业秘密应当保密。
Article 28 Medicinal products shall meet the national medicinal product standards. Where any medicinal product quality standards approved by the medicinal product regulatory department of the State Council are higher than the national medicinal product standards, the approved medicinal product quality standards shall prevail; and absent national medicinal product standards, the approved medicinal product quality standards shall be met.   第二十八条 药品应当符合国家药品标准。经国务院药品监督管理部门核准的药品质量标准高于国家药品标准的,按照经核准的药品质量标准执行;没有国家药品标准的,应当符合经核准的药品质量标准。
The Pharmacopoeia of the People's Republic of China and the medicinal product standards promulgated by the medicinal product regulatory department of the State Council shall be the national medicinal product standards. 国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。
The medicinal product regulatory department of the State Council shall, in conjunction with the health department of the State Council, organize a pharmacopoeia committee responsible for the development and revision of the national medicinal product standards. 国务院药品监督管理部门会同国务院卫生健康主管部门组织药典委员会,负责国家药品标准的制定和修订。
The medicinal product control institutions established or designated by the medicinal product regulatory department of the State Council shall be responsible for establishing national biological reference preparations and chemical reference substances for medicinal products. 国务院药品监督管理部门设置或者指定的药品检验机构负责标定国家药品标准品、对照品。
Article 29 The names of medicinal products listed in the national medicinal product standards shall be the generic names of medicinal products. The names which have become the generic names of medicinal products shall not be used as trademarks of medicinal products.   第二十九条 列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的,该名称不得作为药品商标使用。
Chapter III Holders of Marketing Authorization for Medicinal Products 

第三章 药品上市许可持有人

Article 30 Marketing authorization holders are enterprises or pharmaceutical research and development institutions, among others, which have obtained registration certificates for medicinal products.   第三十条 药品上市许可持有人是指取得药品注册证书的企业或者药品研制机构等。
Marketing authorization holders shall be responsible for the nonclinical laboratory studies, clinical trials, manufacture, distribution, post-market studies, and surveillance, reporting, and disposition of adverse reactions, among others, of medicinal products in accordance with the provisions of this Law. Any other entity or individual engaged in the research and development, manufacture, distribution, storage, transportation, or use, among others, of medicinal products shall assume corresponding responsibility in accordance with the law. 药品上市许可持有人应当依照本法规定,对药品的非临床研究、临床试验、生产经营、上市后研究、不良反应监测及报告与处理等承担责任。其他从事药品研制、生产、经营、储存、运输、使用等活动的单位和个人依法承担相应责任。
The legal representative or the primary person in charge of a marketing authorization holder shall be fully responsible for medicinal product quality. 药品上市许可持有人的法定代表人、主要负责人对药品质量全面负责。
Article 31 A marketing authorization holder shall establish a medicinal product quality assurance system, and employ specialized personnel independently responsible for medicinal product quality management.   第三十一条 药品上市许可持有人应当建立药品质量保证体系,配备专门人员独立负责药品质量管理。
A marketing authorization holder shall regularly review the quality management systems of the authorized manufacturers and distributors of the approved medicinal product, and oversee their continuing capabilities of quality assurance and control. 药品上市许可持有人应当对受托药品生产企业、药品经营企业的质量管理体系进行定期审核,监督其持续具备质量保证和控制能力。
Article 32 A marketing authorization holder may manufacture the registered medicinal product itself or authorize a manufacturer of medicinal products to manufacture the registered medicinal product.   第三十二条 药品上市许可持有人可以自行生产药品,也可以委托药品生产企业生产。
A marketing authorization holder shall obtain a manufacturing permit for medicinal products in accordance with the provisions of this Law if it manufactures the registered medicinal product itself; or if it authorizes a manufacturer of medicinal products to manufacture the registered medicinal product, the authorized manufacturer shall meet the prescribed conditions. The marketing authorization holder and the authorized manufacturer shall enter into an agreement on the authorized manufacture and a quality agreement, and strictly perform their obligations under the agreements. 药品上市许可持有人自行生产药品的,应当依照本法规定取得药品生产许可证;委托生产的,应当委托符合条件的药品生产企业。药品上市许可持有人和受托生产企业应当签订委托协议和质量协议,并严格履行协议约定的义务。
The medicinal product regulatory department of the State Council shall develop the guidance on quality agreements for the authorized manufacture of medicinal products, and guide and oversee the marketing authorization holders and authorized manufacturers in performing their obligations to assure medicinal product quality. 国务院药品监督管理部门制定药品委托生产质量协议指南,指导、监督药品上市许可持有人和受托生产企业履行药品质量保证义务。
Marketing authorization holders may not outsource the manufacture of blood products, narcotic drugs, psychotropic substances, poisonous substances for medical use, and pharmaceutical precursor chemicals, except as otherwise specified by the medicinal product regulatory department of the State Council. 血液制品、麻醉药品、精神药品、医疗用毒性药品、药品类易制毒化学品不得委托生产;但是,国务院药品监督管理部门另有规定的除外。
Article 33 A marketing authorization holder shall establish the rules and procedures for the release of medicinal products to be placed on the market, review the ex-factory medicinal products released by a manufacturer of medicinal products, and grant release only upon signature of the qualified person. Medicinal products in nonconformity with the national medicinal product standards may not be released.   第三十三条 药品上市许可持有人应当建立药品上市放行规程,对药品生产企业出厂放行的药品进行审核,经质量受权人签字后方可放行。不符合国家药品标准的,不得放行。
Article 34 A marketing authorization holder may itself sell the medicinal product for which a registration certificate has been obtained, or authorize a distributor of medicinal products to sell the registered medicinal products. A marketing authorization holder engaged in the retailing of medicinal products shall obtain a distribution permit for medicinal products.   第三十四条 药品上市许可持有人可以自行销售其取得药品注册证书的药品,也可以委托药品经营企业销售。药品上市许可持有人从事药品零售活动的,应当取得药品经营许可证。
A marketing authorization holder shall meet the conditions as set forth in Article 52 of this Law if it sells the registered medicinal product itself; or if it authorizes a distributor of medicinal products to sell the registered medicinal products, the authorized distributor shall meet the prescribed conditions. The marketing authorization holder and the authorized distributor shall enter into an agreement on the authorized distribution, and strictly perform the obligations under the agreement. 药品上市许可持有人自行销售药品的,应当具备本法第五十二条规定的条件;委托销售的,应当委托符合条件的药品经营企业。药品上市许可持有人和受托经营企业应当签订委托协议,并严格履行协议约定的义务。
Article 35 Where a marketing authorization holder or a manufacturer or distributor of medicinal products outsources the storage or transportation of medicinal products, it shall assess the quality assurance and risk management capabilities of the authorized service provider, enter into a storage or transportation agreement with the authorized service provider, covering, among others, the liability for medicinal product quality and the operating rules and procedures, and oversee the authorized service provider.   第三十五条 药品上市许可持有人、药品生产企业、药品经营企业委托储存、运输药品的,应当对受托方的质量保证能力和风险管理能力进行评估,与其签订委托协议,约定药品质量责任、操作规程等内容,并对受托方进行监督。
Article 36 Marketing authorization holders, manufacturers and distributors of medicinal products, and medical institutions shall establish and implement their medicinal product traceability systems, provide traceability information as required, and ensure the traceability of medicinal products.   第三十六条 药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当建立并实施药品追溯制度,按照规定提供追溯信息,保证药品可追溯。
Article 37 A marketing authorization holder shall establish an annual reporting system, and annually report its manufacture and sale of medicinal products, post-market studies, risk management, and other information to the medicinal product regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government as required.   第三十七条 药品上市许可持有人应当建立年度报告制度,每年将药品生产销售、上市后研究、风险管理等情况按照规定向省、自治区、直辖市人民政府药品监督管理部门报告。
Article 38 Where a marketing authorization holder is an overseas enterprise, a corporate enterprise in China designated by it shall perform the obligations of the marketing authorization holder, and assume joint and several liability with the marketing authorization holder.   第三十八条 药品上市许可持有人为境外企业的,应当由其指定的在中国境内的企业法人履行药品上市许可持有人义务,与药品上市许可持有人承担连带责任。
Article 39 A manufacturer of traditional Chinese medicinal decoction pieces shall perform the relevant obligations of a marketing authorization holder, implement the whole process management of the manufacture and sale of decoction pieces, establish a traceability system of decoction pieces, and ensure the safety, efficacy, and traceability of decoction pieces.   第三十九条 中药饮片生产企业履行药品上市许可持有人的相关义务,对中药饮片生产、销售实行全过程管理,建立中药饮片追溯体系,保证中药饮片安全、有效、可追溯。
Article 40 A marketing authorization holder may assign the marketing authorization with the approval of the medicinal product regulatory department of the State Council. The assignee shall have the capabilities of quality management, risk prevention and control, and payment of damages, among others, to ensure the safety, efficacy, and quality controllability of medicinal products, and perform the obligations of a marketing authorization holder.   第四十条 经国务院药品监督管理部门批准,药品上市许可持有人可以转让药品上市许可。受让方应当具备保障药品安全性、有效性和质量可控性的质量管理、风险防控和责任赔偿等能力,履行药品上市许可持有人义务。
Chapter IV Manufacture of Medicinal Products 

第四章 药品生产

Article 41 To be engaged in the manufacture of medicinal products, one shall be subject to the approval of the medicinal product regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and obtain a manufacturing permit for medicinal products. No medicinal products may be manufactured without a manufacturing permit for medicinal products.   第四十一条 从事药品生产活动,应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准,取得药品生产许可证。无药品生产许可证的,不得生产药品。
A manufacturing permit for medicinal products shall state a period of validity and a scope of manufacture, and upon expiration, shall be reissued after examination. 药品生产许可证应当标明有效期和生产范围,到期重新审查发证。
Article 42 To be engaged in the manufacture of medicinal products, one shall meet the following conditions:   第四十二条 从事药品生产活动,应当具备以下条件:
(1) It has pharmacy technicians, engineering technicians, and corresponding skilled workers, who are qualified in accordance with the law. (一)有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人;
(2) It has the factory premises, facilities, and hygienic environment suitable for the manufacture of medicinal products. (二)有与药品生产相适应的厂房、设施和卫生环境;
(3) It has the institutions and personnel capable of conducting quality management and quality inspection of the medicinal products manufactured as well as necessary instruments and equipment. (三)有能对所生产药品进行质量管理和质量检验的机构、人员及必要的仪器设备;
(4) It has the rules and regulations to assure quality of medicinal products, and complies with the requirements of the good manufacturing practice (“GMP”) for medicinal products developed by the medicinal product regulatory department of the State Council in accordance with this Law. (四)有保证药品质量的规章制度,并符合国务院药品监督管理部门依据本法制定的药品生产质量管理规范要求。
Article 43 One engaged in the manufacture of medicinal products shall comply with the GMP for medicinal products, establish and improve a quality management system for the manufacture of medicinal products, and ensure the continuing compliance of the whole process of manufacture of medicinal productions with the statutory requirements.   第四十三条 从事药品生产活动,应当遵守药品生产质量管理规范,建立健全药品生产质量管理体系,保证药品生产全过程持续符合法定要求。
The legal representative or the primary person in charge of a manufacturer of medicinal products shall be fully responsible for the enterprise's manufacture of medicinal products. 药品生产企业的法定代表人、主要负责人对本企业的药品生产活动全面负责。
Article 44 Medicinal products shall be manufactured in accordance with the national medicinal product standards and the manufacturing processes reviewed and approved by the medicinal product regulatory department of the State Council. The records of manufacture and inspection shall be complete and accurate, and may not be fabricated.   第四十四条 药品应当按照国家药品标准和经药品监督管理部门核准的生产工艺进行生产。生产、检验记录应当完整准确,不得编造。
Traditional Chinese medicinal decoction pieces shall be processed in accordance with the national medicinal product standards; or in the absence of the national medicinal product standards, be processed in accordance with the processing specifications developed by the medicinal product regulatory department of the province, autonomous region, or municipality directly under the central government. The processing specifications developed by the medicinal product regulatory department of a province, autonomous region, or municipality directly under the central governments shall be filed with the medicinal product regulatory department of the State Council. Decoction pieces which are not processed in accordance with the national medicinal product standards or the processing specifications developed by the medicinal product regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government may not leave the factory or be sold. 中药饮片应当按照国家药品标准炮制;国家药品标准没有规定的,应当按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制的,不得出厂、销售。
Article 45 The raw materials and inactive ingredients needed for the manufacture of medicinal products shall satisfy the requirements for medicinal use and the relevant requirements of the GMP for medicinal products.   第四十五条 生产药品所需的原料、辅料,应当符合药用要求、药品生产质量管理规范的有关要求。
In the manufacture of medicinal products, the suppliers of raw materials and inactive ingredients, among others, shall be examined as required to ensure that the raw materials and inactive ingredients, among others, purchased and used satisfy the requirements of the preceding paragraph. 生产药品,应当按照规定对供应原料、辅料等的供应商进行审核,保证购进、使用的原料、辅料等符合前款规定要求。
Article 46 Packaging materials and containers immediately in contact with medicinal products shall satisfy the requirements for medicinal use, and meet the standards for protecting human health and safety.   第四十六条 直接接触药品的包装材料和容器,应当符合药用要求,符合保障人体健康、安全的标准。
The medicinal product regulatory departments shall order cessation of use of noncompliant packaging materials and containers in direct contact with medicinal products. 对不合格的直接接触药品的包装材料和容器,由药品监督管理部门责令停止使用。
Article 47 A manufacturer of medicinal products shall conduct quality inspection on its medicinal products. Those in nonconformity with the national medicinal product standards may not leave the factory.   第四十七条 药品生产企业应当对药品进行质量检验。不符合国家药品标准的,不得出厂。
A manufacturer of medicinal products shall establish the rules and procedures for the release of ex-factory medicinal products, and specify the standards and conditions for ex-factory release. Those meeting the standards and conditions may be released upon signature of the qualified person. 药品生产企业应当建立药品出厂放行规程,明确出厂放行的标准、条件。符合标准、条件的,经质量受权人签字后方可放行。
Article 48 The packaging of medicinal products shall conform to the requirements for medicinal product quality, and facilitate storage, transportation, and medical use.   第四十八条 药品包装应当适合药品质量的要求,方便储存、运输和医疗使用。
Traditional Chinese medicinal materials shall be packaged before transportation. The name of product, place of production, date, and supplier shall be indicated on each package, and a quality compliance mark shall be affixed thereto. 发运中药材应当有包装。在每件包装上,应当注明品名、产地、日期、供货单位,并附有质量合格的标志。
Article 49 Labels shall be printed on or glued to the packaging of a medicinal product, accompanied with a package leaflet, as required.   第四十九条 药品包装应当按照规定印有或者贴有标签并附有说明书。
A label or package leaflet shall state a medicinal product's generic name, ingredients, specifications, marketing authorization holder with address, manufacturer with address, approval number, batch number, production date, expiry date, therapeutic indications or actions and indications, usage, dosage, contraindications, adverse reactions, and warnings and precautions. The language on the label and package leaflet shall be clear, and matters such as production date and expiry date shall be marked conspicuously and easily legible. 标签或者说明书应当注明药品的通用名称、成份、规格、上市许可持有人及其地址、生产企业及其地址、批准文号、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、禁忌、不良反应和注意事项。标签、说明书中的文字应当清晰,生产日期、有效期等事项应当显著标注,容易辨识。
The required marks shall be printed on the labels and package leaflets of narcotic drugs, psychotropic substances, poisonous substances for medical use, radiopharmaceuticals, medicinal products for external use, and non-prescription medicinal products. 麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药的标签、说明书,应当印有规定的标志。
Article 50 The personnel of marketing authorization holders, manufacturers and distributors of medicinal products, and medical institutions who are immediately in contact with medicinal products shall annually undergo a medical examination. Those suffering from any infectious disease or other disease which may contaminate medicinal products may not work immediately in contact with medicinal products.   第五十条 药品上市许可持有人、药品生产企业、药品经营企业和医疗机构中直接接触药品的工作人员,应当每年进行健康检查。患有传染病或者其他可能污染药品的疾病的,不得从事直接接触药品的工作。
Chapter V Distribution of Medicinal Products 

第五章 药品经营

Article 51 To be engaged in the wholesale distribution of medicinal products, one shall be subject to the approval of the medicinal product regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and obtain a distribution permit for medicinal products. To be engaged in the retailing of medicinal products, one shall be subject to the approval of the medicinal product regulatory department of the local people's government at or above the county level, and obtain a distribution permit for medicinal products. No medicinal products may be distributed without a distribution permit for medicinal products.   第五十一条 从事药品批发活动,应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准,取得药品经营许可证。从事药品零售活动,应当经所在地县级以上地方人民政府药品监督管理部门批准,取得药品经营许可证。无药品经营许可证的,不得经营药品。
A distribution permit for medicinal products shall state a period of validity and a scope of distribution, and upon expiration, shall be reissued after examination. 药品经营许可证应当标明有效期和经营范围,到期重新审查发证。
In implementing the licensure of distribution of medicinal products, medicinal product regulatory departments shall also follow the principle of convenience for people's purchase of medicinal products, subject to the conditions as set forth in Article 52 of this Law. 药品监督管理部门实施药品经营许可,除依据本法第五十二条规定的条件外,还应当遵循方便群众购药的原则。
Article 52 To be engaged in the distribution of medicinal products, one shall meet the following conditions:   第五十二条 从事药品经营活动应当具备以下条件:
(1) It has pharmacists or other pharmacy technicians, who are qualified in accordance with the law. (一)有依法经过资格认定的药师或者其他药学技术人员;
(2) It has the business premises, equipment, storage facilities, and hygienic environment suitable for the medicinal products distributed. (二)有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境;
(3) It has the quality management institutions or personnel suitable for the medicinal products distributed. (三)有与所经营药品相适应的质量管理机构或者人员;
(4) It has the rules and regulations to assure quality of medicinal products, and complies with the requirements of the good supply practice (“GSP”) for medicinal products developed by the medicinal product regulatory department of the State Council in accordance with this Law.
......
 (四)有保证药品质量的规章制度,并符合国务院药品监督管理部门依据本法制定的药品经营质量管理规范要求。
......

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