【中英文对照版】药品生产监督管理办法(2020).docx

药品生产监督管理方法(2020)Measures for the Supervision and Administration of Drug Production (2020)【中英文对照版】发布部门：国家市场监督管理总局发文字号:发文字号:家市场监督管理总局令第28号发布日期：实施日期：效力级别：部门规章法规类别：法规规章制定与发布药品管理Issuing Authority : State Administration for Market RegulationDocument Number : Order No. 28 of the State Administration for Market RegulationDate Issued : 01 -22-2020Effective Date ： 07-01-2020Level of Authority : Departmental RulesArea of Law : Formulation and Promulgation of Regulations and Rules PharmaceuticalAdministrationOrder of the State Administration for Market Regulation国家市场监督管理总局令(No. 28)（第28号）The Measures for the Supervision and Administration of Drug Production, as deliberated and adopted at the 1st executive meeting of the State Administration for Market Regulation on January 15, 2020, are hereby issued and shall come into force on July 1, 2020.药品生产监督管理方法已于 2020年1月15日经国家市场监 督管理总局2020年第1次局务 会议审议通过，现予公布，自 2020年7月1日起施行。Direct。亡 Xiao Yaqing局长肖亚庆January 22, 20202020年1月22日Measures for the Supervision and Administration of Drug Production药品生产监督管理方法(Issued by Order No. 28 of the State Administration for Market Regulation, January 22, 2020)（2020年1月22日国家市场监 督管理总局令第28号公布）规范符合性检查，检查结果应当 通知企业。检查结果符合规定， 产品符合放行要求的可以上市销 售。有关变更情况，应当在药品 生产许可证副本中载明。上述变更事项涉及药品注册证书 及其附件载明内容的，由省、自 治区、直辖市药品监督管理部门 批准后，报国家药品监督管理局 药品审评中心更新药品注册证书 及其附件相关内容。第十七条 变更药品生产许 可证登记事项的，应当在市场监 督管理部门核准变更或者企业完 成变更后三十日内，向原发证机 关申请药品生产许可证变更登 记。原发证机关应当自收到企业 变更申请之日起十日内办理变更 手续。第十八条药品生产许可证 变更后，原发证机关应当在药品 生产许可证副本上记录变更的内 容和时间，并按照变更后的内容 重新核发药品生产许可证正本， 收回原药品生产许可证正本，变 更后的药品生产许可证终止期限 不变。第十九条 药品生产许可证 有效期届满，需要继续生产药品 的，应当在有效期届满前六个 月，向原发证机关申请重新发放 药品生产许可证。Government in the local area, and the examination results shall be notified of the enterprise. Where the examination results comply with the provisions and the product satisfies the requirements for release, it may be sold on the market. The relevant alteration shall be specified in the duplicate of the drug production license.Where the alteration involves the contents specified in the drug production license and its annex, with approval of the medical products administrative department of the province, autonomous region, or municipality directly under the Central Government, it shall be reported to the Center for Drug Evaluation of NMPA for updating the relevant contents of the drug registration certificate and its annex.Article 17 For change in a registration item of a drug production license, an application for alteration registration of the drug production license shall be filed with the original license issuer within 30 days after the market regulatory department verifies the alteration or the enterprise completes alteration. The original license issuer shall, within 10 days upon receipt of an application for alteration, handle the formalities of alteration.Article 18 After a drug production license is changed, the original license issuer shall record the contents and time of alteration in the duplicate of the drug production license, reverify and re-issue an original drug production license according to the contents altered, and take back the former original drug production license. The period of validity of the drug production license shall remain unchanged.Article 19 Where drugs need to be produced continuously upon expiry of the validity period of a drug production license, an application for reissuance of a drug production license shall be filed with the original license issuer six months prior to the expiry of the validity period.The original license issuer shall, in combination with an 原发证机关结合企业遵守药品管10enterprise's compliance with the laws and regulations on drug administration and the management standards for drug production quality, and the operation of the quality system, conduct examination under the risk management principle, and make a decision of approving or disapproving issuance of a new license prior to the expiry of the validity period of the drug production license. Where the provisions are complied with and issuance of a new license is approved, the original license shall be taken back and a new license shall be issued; where the provisions are not complied with, a written decision of disapproving issuance of a new license shall be made, the reasons shall be explained, and the applicant shall be concurrently notified of enjoying the right to apply for administrative reconsideration or institute an administrative action; and where a decision is not made within the prescribed time limit, it shall be deemed agreeing with reissuance, and the corresponding formalities shall be undergone in a supplementary manner.Article 20 Under one of the following circumstances, a drug production license shall be canceled by the original license issuer and an announcement shall be made:(1) An application is proactively filed for cancelling the drug production license.(2) Where a new license is not issued upon expiry of the validity period of the drug production license.(3) The business license is revoked or cancelled according to the law.(4) The drug production license is revoked or cancelled according to the law.(5) Other circumstances under which administrative licensing shall be cancelled as prescribed by the laws and regulations.理法律法规、药品生产质量管理规范和质量体系运行情况，根据 风险管理原那么进行审查，在药品 生产许可证有效期届满前作出是 否准予其重新发证的决定。符合 规定准予重新发证的，收回原 证，重新发证；不符合规定的， 作出不予重新发证的书面决定，并说明理由，同时告知申请人享 有依法申请行政复议或者提起行 政诉讼的权利；逾期未作出决定 的，视为同意重新发证，并予补 办相应手续。第二十条 有以下情形之一 的，药品生产许可证由原发证机 关注销，并予以公告：（一）主动申请注销药品生产许 可证的；（二）药品生产许可证有效期届 满未重新发证的；（三）营业执照依法被撤消或者 注销的；（四）药品生产许可证依法被吊 销或者撤销的；（五）法律、法规规定应当注销 行政许可的其他情形。第二十一条药品生产许可 证遗失的，药品上市许可持有 人、药品生产企业应当向原发证 机关申请补发，原发证机关按照Article 21 Where a drug production license is lost, the drug marketing authorization holder and a drug manufacturer shall apply to the original license issuer for reissuance, and the original license issuer shall reissue a drug production license within 10 days according to the matters originally confirmed.The license number and validity period shall be consistent with 原核准事项在十日内补发药品生the original license,产许可证。许可证编号、有效期等与原许可证一致。Article 22 No entity or individual may forge, alter, lease, lend, sell or buy any drug production license.第二十二条任何单位或者 个人不得伪造、变造、出租、出 借、买卖药品生产许可证。Article 23 The medical products administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall update the handling of verification and issuance, issuance of a new license, alteration, reissuance, revocation, and cancellation, among others, of a drug production license, and update the drug safety credit files within 10 days after handling.第一十二条 省、白治区 直辖市药品正看管理部门应当将 药品生产许可证核发、重新发 证、变更、补发、撤消、撤销、 注销等办理情况，在办理工作完 成后十日内在药品平安信用档案 中更新。Chapter III Production Management第三章生产管理Article 24 For the drug production activities, the management standards for drug production quality shall be met, production shall be conducted in accordance with the national drug standards, and the drug registration standards and production processes approved by the medical products administrative department, the premise management files shall be submitted and continuously updated according to the provisions, and risk assessment and continuous improvement shall be conducted for the whole operation process of the quality system. Production and inspection records shall be complete and accurate, and shall not be fabricated or tampered with.第二十四条从事药品生产 活动，应当遵守药品生产质量管 理规范，按照国家药品标准、经 药品监督管理部门核准的药品注 册标准和生产工艺进行生产，按 照规定提交并持续更新场地管理 文件，对质量体系运行过程进行 风险评估和持续改进，保证药品 生产全过程持续符合法定要求。 生产、检验等记录应当完整准 确，不得编造和篡改。Article 25 A vaccine marketing authorization holder shall have the plant facilities and equipment required for vaccine production and inspection, be equipped with qualified management personnel, establish a sound quality management system, and have the ability to produce vaccines satisfying the第二十五条疫苗上市许可 持有人应当具备疫苗生产、检验 必需的厂房设施设备，配备具有 资质的管理人员，建立完善质量12管理体系，具备生产出符合注册 要求疫苗的能力，超出疫苗生产 能力确需委托生产的，应当经国registration requirements. Where the production indeed needs to be entrusted beyond the vaccine production capacity, approval of NMPA shall be obtained.家药品监督管理局批准。Article 26 For carrying out drug production activities, the management standards for drug production quality shall be complied with, and the drug production quality management system shall be established and improved, covering all factors affecting the quality of drugs, to ensure that the entire process of drug production continuously satisfies the legal requirements.第二十六条从事药品生产 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，涵盖影响药品质量的 所有因素，保证药品生产全过程 持续符合法定要求。Article 27 A drug marketing authorization holder shall establish a drug quality assurance system, appoint special personnel to be independently responsible for drug quality management, conduct regular inspection of the quality management systems of entrusted drug manufacturers and drug distributors, and monitor their continuous possession of capacity for quality assurance and control.第二十七条药品上市许可 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，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 28 The legal representative and primary person in charge of a drug marketing authorization holder shall be fully responsible for the quality of drugs and perform the following duties:第二十八条药品上市许可 持有人的法定代表人、主要负责 人应当对药品质量全面负责，履 行以下职责：(1) They shall appoint a special person in charge of quality to be independently responsible for the management of drug quality.（一）配备专门质量负责人独立 负责药品质量管理；(2) They shall appoint a special qualified person to independently perform the responsibility of drug marketing clearance.（二）配备专门质量受权人独立 履行药品上市放行责任；(3) They shall supervise the normal operation of the quality management system.（三）监督质量管理体系正常运 行；(4) They shall review the quality system of the activities of drug manufacturers, suppliers, and relevant parties concerning drug production on a regular basis, and ensure continuous compliance.（四）对药品生产企业、供应商 等相关方与药品生产相关的活动 定期开展质量体系审核，保证持13续合规;(5) They shall, according to the technical requirements for alteration, perform the responsibilities for management of alteration.（五）按照变更技术要求，履行 变更管理责任；(6) They shall assess the quality of an entrusted business enterprise and conduct information communication with the using entities.（六）对委托经营企业进行质量 评估，与使用单位等进行信息沟 通；(7) They shall cooperate with the medical products administrative department in the extended examination of the drug marketing authorization holder and related parties.（七）配合药品监督管理部门对 药品上市许可持有人及相关方的 延伸检查；(8) They shall report the major safety incidents related to the quality of drugs in a timely manner, dispose of risks according to the risk management plan developed by the holder, and ensure that the risks are controlled in a timely manner.（八）发生与药品质量有关的重 大平安事件，应当及时报告并按 持有人制定的风险管理计划开展 风险处置，确保风险得到及时控 制；(9) Other responsibilities prescribed by the laws and regulations.（九）其他法律法规规定的责 任。Article 29 The legal representative and primary person in charge of a drug manufacturer shall be fully responsible for the drug production activities of the enterprise and perform the following duties:第二十九条 药品生产企业 的法定代表人、主要负责人应当 对本企业的药品生产活动全面负 责，履行以下职责：(1) They shall appoint a special person in charge of quality to be independently responsible for the management of drug quality, supervise the implementation of the management standards for quality, ensure appropriate control over the production process and quality, and ensure that the drugs comply with the national drug standards and drug registration standards.（一）配备专门质量负责人独立 负责药品质量管理，监督质量管 理规范执行，确保适当的生产过 程控制和质量控制，保证药品符 合国家药品标准和药品注册标 准；(2) They shall appoint a special qualified person to perform the responsibility of drug delivery clearance.（二）配备专门质量受权人履行 药品出厂放行责任；(3) They shall supervise the normal operation of the quality management system to ensure the control over the drug production process and quality, and the authenticity of records and data.（三）监督质量管理体系正常运 行，保证药品生产过程控制、质 量控制以及记录和数据真实性；14（四）发生与药品质量有关的重 大平安事件，应当及时报告并按 企业制定的风险管理计划开展风 险处置，确保风险得到及时控 制；（五）其他法律法规规定的责 任。第三十条药品上市许可持 有人、药品生产企业应当每年对 直接接触药品的工作人员进行健 康检查并建立健康档案，防止患 有传染病或者其他可能污染药品 疾病的人员从事直接接触药品的 生产活动。第三十一条药品上市许可 持有人、药品生产企业在药品生 产中，应当开展风险评估、控 制、验证、沟通、审核等质量管 理活动，对已识别的风险及时采 取有效的风险控制措施，以保证 产品质量。第三十二条 从事药品生产 活动，应当对使用的原料药、辅 料、直接接触药品的包装材料和 容器等相关物料供应商或者生产 企业进行审核，保证购进、使用 符合法规要求。生产药品所需的原料、辅料，应 当符合药用要求以及相应的生产 质量管理规范的有关要求。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、平安的标准。(4) They shall report the major safety incidents related to the quality of drugs in a timely manner, dispose of risks according to the risk management plan developed by the enterprise, and ensure that the risks are controlled in a timely manner.(5) Other responsibilities prescribed by the laws and regulations.Article 30 A drug marketing authorization holder and a drug manufacturer shall conduct annual health checkups for staff members in direct contact with drugs and establish health files, and prevent personnel with infectious diseases or other diseases that may possibly contaminate drugs from directly contacting the drugs in the production activities.Article 31 A drug marketing authorization holder and a drug manufacturer shall, in drug production, conduct quality management activities such as risk assessment, control, verification, communication, and examination, and take effective risk control measures for risks identified in a timely manner, to ensure the product quality.Article 32 For drug production activities, a supplier or manufacturer of APIs, auxiliary materials, packaging materials and containers in direct contact with drugs and other relevant materials used shall be examined, to ensure that the purchase and use satisfy the regulatory requirements.The raw materials and auxiliary materials required for production of drugs shall satisfy the requirements for medicinal use and the relevant requirements of the corresponding management standards for production quality. Packaging materials and containers in direct contact with drugs shall satisfy the requirements for medicinal use and meet the standards for protecting human health and safety.15A manufacturer of APIs, auxiliary materials, packaging materials and containers in direct contact with drugs that have been approved or have passed related evaluation and approval shall comply with the quality management standards developed by NMPA and the relevant requirements for related evaluation and approval, ensure the continuous compliance of the quality assurance system, accept the quality examination of the drug marketing authorization holder, and accept the supervisory inspection or extended examination of the medical products administrative department.第三十三条经批准或者通 过关联审评审批的原料药、辅