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Pharmaceutical Administration Law of the People's Republic of China (2019 Revision) [Not Yet Effective]
中华人民共和国药品管理法(2019修订) [尚未生效]
【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 Pharmaceutical Administration Law of the People's Republic of China as revised at the Twelfth 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。
President of the People's Republic of China: Xi Jinping 中华人民共和国主席 习近平
August 26, 2019 2019年8月26日
Pharmaceutical Administration Law of the People's Republic of China 中华人民共和国药品管理法
(Adopted at the Seventh Session of the Standing Committee of the Sixth National People's Congress on September 20, 1984, revised at the Twentieth Session of the Ninth National People's Congress on February 28, 2001 and amended for the first time in accordance with the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the People's Republic of China at the Sixth Session of the Standing Committee of the Twentieth National People's Congress on December 28, 2013; amended for the second time in accordance with the Decision on Amending the Pharmaceutical 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 Twelfth 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 Pharmaceutical Development and Registration 第二章 药品研制和注册
Chapter III Pharmaceutical Marketing Authorization Holders 第三章 药品上市许可持有人
Chapter IV Pharmaceutical Production 第四章 药品生产
Chapter V Pharmaceutical Distribution 第五章 药品经营
Chapter VI Medical Institutions' Management of Pharmaceutical Affairs 第六章 医疗机构药事管理
Chapter VII Post-market Pharmaceutical Management 第七章 药品上市后管理
Chapter VIII Pharmaceutical Prices and Advertising 第八章 药品价格和广告
Chapter IX Pharmaceutical Reserves and Supply 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 Supplementary 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 strengthening pharmaceutical administration, ensuring pharmaceutical quality, guaranteeing 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 The law shall be applicable to the development, production, distribution, use, and supervision and administration of pharmaceuticals within 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 purpose of this Law, “pharmaceuticals” means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed, including Chinese medicine, chemical pharmaceuticals, 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 Pharmaceutical administration shall center on people's health, adhere to the principles of risk management, management and control in the whole process, and co-governance by whole society, establish a scientific and strict supervision and administration system, comprehensively improve pharmaceutical quality, and guarantee the safety, effectiveness, and accessibility of pharmaceuticals.   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 pharmaceuticals and give full play to their role in the prevention and treatment of diseases and in health care.   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 resources of wild medicinal materials and varieties of Chinese medicine and encourage the cultivation of genuine Chinese medicinal materials. 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 production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.   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 The state shall implement a pharmaceutical marketing authorization holder system for pharmaceutical management. A pharmaceutical marketing authorization holder shall be responsible for the safety, effectiveness, and quality controllability of pharmaceuticals during the whole process of the development, production, distribution, and use of the pharmaceuticals, as legally required.   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 One that engages in pharmaceutical development, manufacturing, distribution or use activities shall abide by the laws, regulations, rules, standards, and specifications and ensure the authenticity, accuracy, integrity, and traceability of information in the whole process.   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 medical products administration under the State Council shall be responsible for the supervision and administration of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for pharmaceuticals-related supervision and administration within the scope of their functions. The medical products administration under the State Council shall cooperate with other relevant departments under the State Council in implementing national pharmaceutical industry development plans 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 medical products administrations 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 pharmaceuticals within their administrative regions. The department of a people's government at or above districted city or county level charged with the function of pharmaceutical supervision and administration (hereinafter referred to as the “medical products administration”) shall be responsible for the supervision and administration of pharmaceuticals within its administrative region. The relevant departments of local people's governments at or above county level shall be responsible for pharmaceuticals-related supervision and administration within the scope of their 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 A local people's government at or above county level shall be responsible the supervision and administration of pharmaceuticals within its administrative region, lead, organize, and coordinate the supervision and administration of pharmaceuticals and pharmaceutical safety emergency response work within the administrative region in a unified manner, and establish and improve a supervision and administration mechanism and an information sharing mechanism for pharmaceutical safety.   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 A local people's government at or above county level shall incorporate pharmaceutical safety work into the national economic and social development plan at the same level, include the funds for the pharmaceutical safety work in its budget, strengthen the capacity building for the supervision and administration of pharmaceuticals, and provide guarantees for pharmaceutical safety.   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 A specialized pharmaceuticals technical institution established or designated by any medical products administration shall undertake evaluation, inspection, verification, monitoring and evaluation, and other work necessary for the implementation of the supervision and administration of pharmaceuticals according to 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 pharmaceutical traceability system. The medical products administration under the State Council shall develop unified pharmaceutical traceability standards and specifications, advance the mutual accessibility and sharing of pharmaceutical traceability information, and achieving pharmaceutical 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 pharmaceutical reactions and other harmful reactions associated with the use of pharmaceuticals. 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 People's governments at all levels and their relevant departments, pharmaceutical industry associations, and the like shall strengthen publicity and education about pharmaceutical safety and disseminate pharmaceutical 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。
The news media shall give public-welfare publicity on pharmaceutical safety laws and regulations and other knowledge and conduct public opinion supervision of illegal pharmaceutical activities. A report on pharmaceuticals 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 A pharmaceutical industry association shall strengthen industry self-regulation, establish and improve industry standards of practice, promote the building of the industry honesty system, and guide and supervise its members conducting pharmaceutical production and distribution activities according to the law.   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 People's governments at or above county level and their relevant departments shall commend and reward entities and individuals that have made outstanding contributions to the development, production, distribution, use, and supervision and administration of pharmaceuticals in accordance with the relevant provisions issued by the state.   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 Pharmaceutical Development and Registration 

第二章 药品研制和注册

Article 16 The state shall support pharmaceutical innovations oriented to clinical value which have clear or special curative effect on human diseases, encourage the development of new pharmaceuticals which are of a new mechanism of action, treat serious life-threatening diseases or rare diseases, or regulate and intervene in human body in a multi-target and systematic manner, 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 research on science and technology for Chinese medicine and the development of Chinese medicine by using modern science and technology and traditional methods for researching Chinese medicine, establish and improve a technical assessment system that conforms to the characteristics of Chinese medicine, and promote the inheritance of and innovation in Chinese medicine. 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 the development of and innovation in pharmaceuticals for children's use, support the development of new varieties, dosage forms, and specifications of pharmaceuticals for children's use that meet the physiological characteristics of children, and prioritize the evaluation and approval of pharmaceuticals for children's use. 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 Engaging in pharmaceutical development activities shall be in conformity with the Good Laboratory Practice for Pharmaceuticals and the Good Clinical Practice for Pharmaceuticals, so as to ensure that pharmaceutical development continues to conform to statutory requirements in the whole process.   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 Good Laboratory Practice for Pharmaceuticals and the Good Clinical Practice for Pharmaceuticals shall be developed by the medical products administration under the State Council in conjunction with the relevant departments under 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 on pharmaceuticals shall be conducted in conformity with the relevant provisions issued by the state, with personnel, site, equipment, instruments, and management systems appropriate for the research project, the authenticity of relevant data, information, and samples being 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 For clinical trials on pharmaceuticals, relevant data, information, and samples such as development methods, quality indicators, and pharmacological and toxicological testing results shall be truthfully submitted to in accordance with the rules of the medical products administration under the State Council and be subject to its approval. The medical products administration under the State Council shall, within 60 working days from the date of accepting the application for clinical trial, decide whether to grant approval and notify the sponsor of the clinical trial, and its failure to so notify shall be deemed as approval. Bioequivalence testing, if any, shall be filed with the medical products administration under the State Council.   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。
Clinical trials on pharmaceuticals shall be conducted in a clinical trial institution with appropriate conditions. A pharmaceutical clinical trial institution shall be under filing administration, for which specific measures shall be developed jointly by the medical products administration under the State Council and the health department under 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 A clinical trial on pharmaceuticals shall be conducted in conformity with ethical principles, with a clinical trial protocol being developed, and reviewed and approved by 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 for ethical review, ensure that the process of the ethical review is independent, objective, and fair, supervise the clinical trial on pharmaceuticals being conducted in a well-regulated manner, protect the lawful rights and interests of 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 For a clinical trial on pharmaceuticals, the objective, risk, and other particulars of the clinical trial shall be truthfully made known and explained to any of its subjects, or his or her guardian, an informed consent document voluntarily signed by the subject, or his or her guardian, shall be obtained, and effective measures shall be taken to protect the lawful rights and interests of the subject.   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 a safety problem or any other risk is discovered in the process of a clinical trial on pharmaceuticals, the sponsor of the clinical trial shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the medical products administration under the State Council. When necessary, the medical products administration under 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 undergoing clinical trials, intended for the treatment of a seriously life-threatening disease of which there has been no effective treatment, which possibly deliver benefits as indicated by medical observation, in a manner in conformity with the ethical principles, may, with approval and informed consent, be administered in the institution conducting the clinical trials to patients suffering from the same disease.   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 Pharmaceuticals marketed in China shall be approved by the medical products administration under the State Council and be with a pharmaceutical registration certificate, except Chinese medicinal materials and Chinese medicinal herb slices not under approval administration. The list of Chinese medicinal materials and Chinese medicinal herb slices subject to approval administration shall be developed by the medical products administration under the State Council in conjunction with the Chinese medicine department under 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。
For the application for pharmaceutical registration, authentic, sufficient, and reliable data, information, and samples shall be provided, evidencing the safety, effectiveness, and quality controllability of the pharmaceuticals. 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 pharmaceuticals under application for registration, the medical products administration under the State Council shall arrange for pharmaceutical, medical, and other technical personnel to conduct an evaluation to review the safety, effectiveness, and quality controllability of pharmaceuticals and the applicant's capabilities for quality management, risk prevention and control, and payment of damages, among others, and issue a pharmaceutical registration certificate, if the conditions are met.   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。
The medical products administration under the State Council shall, when approving pharmaceuticals, evaluate and approve chemical active ingredients, evaluate relevant inactive ingredients and packaging materials and containers in direct contact with pharmaceuticals, and confirm the quality standards, production processes, and labels and directions for use of the pharmaceuticals. 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 production of pharmaceuticals 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 Pharmaceuticals intended for the treatment of a serious life-threatening disease of which there has been no effective treatment, or urgently needed for public health, of which clinical trials have generated data indicating the curative effects and are able to forecast the clinical value, may be approved subject to conditions, with relevant matters stated in the pharmaceutical registration certificate.   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 medical products administration under the State Council shall improve the working system for the evaluation and approval of pharmaceuticals, strengthen capacity building, establish and improve communication and exchange, expert advice, and other mechanisms, optimize evaluation and approval processes, and improve 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 conclusions and basis approving the marketing of pharmaceuticals shall be disclosed to public in accordance with the law and accept social supervision. Any trade secret known in the course of 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 Pharmaceuticals shall meet national pharmaceutical standards. If the pharmaceutical quality standards confirmed by the medical products administration under the State Council are higher than the national pharmaceutical standards, the confirmed pharmaceutical quality standards shall prevail; and absent national pharmaceutical standards, the confirmed pharmaceutical 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 pharmaceutical standards promulgated by the medical products administration under the State Council shall be national pharmaceutical 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 medical products administration under the State Council shall, in conjunction with the health department under the State Council, organize a pharmacopoeia committee responsible for the development and revision of the national pharmaceutical 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 pharmaceutical inspection institutions established or designated by the medical products administration under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals. 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 the pharmaceuticals listed in the national pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.   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 Pharmaceutical Marketing Authorization Holders 

第三章 药品上市许可持有人

Article 30 “Pharmaceutical marketing authorization holder” means an enterprise, pharmaceutical development institution, or the like that has obtained a pharmaceutical registration certificate.   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。
A pharmaceutical marketing authorization holder shall be responsible for nonclinical laboratory studies, clinical trials, production and distribution, post-market studies, and the monitoring, reporting, and handling of adverse reactions in connection with pharmaceuticals in accordance with the provisions of this Law. Any other entity or individual engaged in the development, production, distribution, storage, transportation, and use of pharmaceuticals shall bear corresponding responsibilities according to 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 principal person in charge of a pharmaceutical marketing authorization holder shall be fully responsible for pharmaceutical 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 pharmaceutical marketing authorization holder shall establish a pharmaceutical quality assurance system and appoint specialized personnel to be independently responsible for the management of pharmaceutical quality.   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 pharmaceutical marketing authorization holder shall regularly review the quality management system of the commissioned pharmaceutical producing enterprises and pharmaceutical distribution enterprises and supervise their continuing to process capabilities for 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 pharmaceutical marketing authorization holder may produce pharmaceuticals by itself, or by a pharmaceutical producing enterprise commissioned to do so.   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 pharmaceutical marketing authorization holder shall obtain a pharmaceutical production license in accordance with the provisions of this Law, if it produces pharmaceuticals by itself, or commission a qualified pharmaceutical producing enterprise, if it commissions the production. The pharmaceutical marketing authorization holder and the commissioned producing enterprise shall enter into a commission agreement and a quality agreement and strictly fulfill the obligations stipulated in 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 medical products administration under the State Council shall develop guidelines for commissioned pharmaceutical production and quality agreements to guide and supervise pharmaceutical marketing authorization holders and commissioned producing enterprises' fulfilling their obligation to assure pharmaceutical 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。
The production of blood products, narcotic pharmaceuticals, psychotropic pharmaceuticals, medical toxic pharmaceuticals, and pharmaceutical precursor chemicals shall not be commissioned, unless otherwise required by the medical products administration under 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 pharmaceutical marketing authorization holder shall establish rules and procedures for pharmaceutical marketing clearances and review pharmaceuticals cleared with the pharmaceutical producing enterprise, so that clearance may be granted only after the qualified person has signed. Unless the national pharmaceutical standards are met, no clearance shall be granted.   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 pharmaceutical marketing authorization holder may sell the pharmaceuticals for which a pharmaceutical registration certificate has been obtained by itself, or by a pharmaceutical distribution enterprise commissioned to do so. If a pharmaceutical marketing authorization holder is engaged in pharmaceutical retailing activities, it shall obtain a pharmaceutical distribution license.   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 pharmaceutical marketing authorization holder shall meet the conditions as set forth in Article 52 of this Law, if it sells pharmaceuticals by itself, or commission a qualified pharmaceutical distribution enterprise, if it commissions the sale. The pharmaceutical marketing authorization holder and the commissioned distribution enterprise shall conclude a commission agreement and strictly perform the obligations stipulated in 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 pharmaceutical marketing authorization holder, pharmaceutical producing enterprise, or pharmaceutical distribution enterprise commissions the storage or transportation of pharmaceuticals, it shall assess the quality assurance capability and risk management capability of the commissioned party, conclude a commission agreement with the commissioned party, stipulating responsibility for pharmaceutical quality, operating rules and procedures, and the like, and supervise the commissioned party.   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 Pharmaceutical marketing authorization holders, pharmaceutical producing enterprises, pharmaceutical distribution enterprises, and medical institutions shall establish and implement a pharmaceutical traceability system, provide traceability information as required, and ensure the traceability of pharmaceuticals.   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 pharmaceutical marketing authorization holder shall establish an annual reporting system and annually report the production and sale of pharmaceuticals, post-market research, risk management, and other information to the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government.   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 pharmaceutical marketing authorization holder is an overseas enterprise, a corporate enterprise in China it designates shall perform the obligation of the pharmaceutical marketing authorization holder and be subject to joint and several liability with the pharmaceutical 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 Chinese medicinal herb slices producing enterprise shall perform the relevant obligations of a pharmaceutical marketing authorization holder, implement the whole-process management of the production and sale of Chinese medicinal herb slices, establish a traceability system for Chinese medicinal herb slices, and ensure the safety, effectiveness, and traceability of Chinese medicinal herb slices.   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 pharmaceutical marketing authorization holder may transfer its marketing authorization of pharmaceuticals, with the approval of the medical products administration under the State Council. The transferee shall have capabilities for quality management, risk prevention and control, and payment of damages guaranteeing the safety, effectiveness, and quality controllability of pharmaceuticals and perform the obligations of a pharmaceutical 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 Pharmaceutical Production 

第四章 药品生产

Article 41 One engaged in pharmaceutical production activities shall receive the approval of the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the activities are conducted and obtain a pharmaceutical production license. Without a pharmaceutical production license, no pharmaceuticals may be produced.   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。
The pharmaceutical production license shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 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 One engaged in pharmaceutical production activities 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 shall be staffed with legally certified pharmacy technicians, engineering technical personnel, as well as corresponding skilled workers. (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 shall have factory premises, facilities and a sanitary environment suitable for the pharmaceutical production. (二)有与药品生产相适应的厂房、设施和卫生环境;
(3) It shall have a unit or competent personnel capable of inspecting the quality of the pharmaceuticals produced, 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 shall have rules and systems assuring pharmaceutical quality and comply with the requirements of the Good Manufacturing Practices for Pharmaceuticals developed by the medical products administration under the State Council according to 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 pharmaceutical production activities shall comply with the Good Manufacturing Practices for Pharmaceuticals, establish and improve a quality management system for pharmaceutical production, and ensure that the entire process of pharmaceutical production continues to meet 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 principal person in charge of a pharmaceutical producing enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise. 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 Pharmaceuticals shall be produced in accordance with the technological procedures confirmed by the medical products administration under the State Council. The records of production 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。
Chinese medicinal herb slices shall be processed according to the national pharmaceutical standards; and in the absence of such standards, the process must conform to the processing standards stipulated by the medical products administration of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the medical products administration of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the medical products administration under the State Council. In the case of inconformity with the national pharmaceutical standards or processing lacking conformity with the processing standards developed by the medical products administration of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, neither delivery nor sale shall be made. 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 Active ingredients and inactive ingredients necessary for the production of pharmaceuticals shall conform to the requirements for medicinal use and the relevant requirements of the Good Manufacturing Practices for Pharmaceuticals.   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。
For the production of pharmaceuticals, a supplier of active ingredients or inactive ingredients shall be reviewed as required to ensure that the active ingredients or inactive ingredients purchased and used meet 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 in direct contact with pharmaceuticals shall conform to the requirements for medicinal use and meet the standards for guaranteeing 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 medical products administrations shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals. 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 pharmaceutical producing enterprise shall conduct quality inspections on pharmaceuticals. In the case of inconformity with the national pharmaceutical standards, no delivery shall be made.   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 pharmaceutical producing enterprise shall establish rules and procedures for pharmaceutical delivery clearances and specify standards and conditions for delivery clearances. If the standards and conditions are met, delivery may be cleared only after the qualified person has signed. 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 Packages of pharmaceuticals shall meet the requirements for pharmaceutical quality and facilitate their 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。
Chinese medicinal materials shall be packaged before transportation. There shall appear on the package the name of the medicine, place of production, date, supplier, and an indication showing that the quality of the medicine is up to standard. 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 Packages of pharmaceuticals shall be labeled and include directions for use in accordance with the regulations.   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。
The label or directions shall indicate the generic name of the medicine, components, specifications, marketing authorization holder and its address, the producer and its address, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions. The words in the label and the directions for use shall be clear, and the production date, expiry date, and other matters shall be marked conspicuously and easily recognizable. 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。
Special indications shall be printed as required on the labels and directions for use of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceuticals for external use and non-prescriptive pharmaceuticals. 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 Personnel in pharmaceutical marketing authorization holders, pharmaceutical producing or trading enterprises and in medical institutions who have direct contact with pharmaceuticals shall undergo an annual medical examination. Those suffering from infectious disease or any other disease that may contaminate the drugs may not engage in the work in direct contact with drugs.   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 Pharmaceutical Distribution 

第五章 药品经营

Article 51 Engaging in pharmaceutical wholesale activities shall be subject to the approval of the medical products administration of the people's government of the province, autonomous region, or municipality directly under the Central Government where the activities are conducted, with a pharmaceutical distribution license obtained. Engaging in pharmaceutical retail activities shall be subject to the approval of the medical products administration of the local people's government at or above the county level in the place of the activities, with a pharmaceutical distribution license obtained. Without a pharmaceutical distribution license, pharmaceuticals may not be distributed.   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 pharmaceutical distribution license shall bear a scope of distribution and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 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。
Medical products administrations shall implement pharmaceutical distribution license by the principle of facilitating people's purchase of pharmaceuticals, in addition to the conditions 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 Engaging in pharmaceutical distribution activities 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 shall be staffed with legally certified pharmacists and other pharmacy technicians. (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 shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades; (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 shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades. (三)有与所经营药品相适应的质量管理机构或者人员;
(4) It shall have rules and systems assuring pharmaceutical quality and comply with the requirements of the Good Distribution Practices for Pharmaceuticals developed by the medical products administration under the State Council according to 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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