| Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
| (No. 39) | | （第39号） |
| The Measures for the Administration of Lot Release of Biological Products, as deliberated and adopted at the executive meeting of the China Food and Drug Administration, are hereby issued and shall come into force on February 1, 2018. | | 《生物制品批签发管理办法》已于2017年12月20日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2018年2月1日起施行。 |
| Director: Bi Jingquan | | 局长：毕井泉 |
| December 29, 2017 | | 2017年12月29日 |
| Measures for the Administration of Lot Release of Biological Products | | 生物制品批签发管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of strengthening supervision and administration of biological products, regulating lot release of biological products, and ensuring the safety and effectiveness of biological products, these Measures are developed in accordance with the relevant provisions of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the "Pharmaceutical Administration Law"). | | 第一条 为加强生物制品监督管理，规范生物制品批签发行为，保证生物制品安全、有效，根据《中华人民共和国药品管理法》（以下简称《药品管理法》）有关规定，制定本办法。 |
| Article 2 For the purpose of these Measures, "lot release of biological products" means the supervisory and administrative action by which the China Food and Drug Administration (hereinafter referred to as the "CFDA") designates a drug inspection institution to conduct document review, on-site verification and sample inspection in connection with vaccine products, blood products, in vitro diagnostics for blood screening, or any other biological products as described by the CFDA, licensed to be marketed, when each product lot is marketed or imported. | | 第二条 本办法所称生物制品批签发，是指国家食品药品监督管理总局（以下简称食品药品监管总局）对获得上市许可的疫苗类制品、血液制品、用于血源筛查的体外诊断试剂以及食品药品监管总局规定的其他生物制品，在每批产品上市销售前或者进口时，指定药品检验机构进行资料审核、现场核实、样品检验的监督管理行为。 |
| The product lot not released may not be marketed or imported. | | 未通过批签发的产品，不得上市销售或者进口。 |
| Article 3 An applicant for lot release shall be a pharmaceutical enterprise, either in or outside China, with certification documents on drug approval. A pharmaceutical enterprise outside China shall appoint its representative office in China or an enterprise legal person in China as its agent to apply for lot release. | | 第三条 批签发申请人应当是持有药品批准证明文件的境内外制药企业。境外制药企业应当授权其驻我国境内办事机构或者我国境内企业法人作为代理人办理批签发。 |
| A product subject to lot release shall be produced according to the technology confirmed by the CFDA. Enterprises shall be responsible for the authenticity of the documents, records and data arising in the course of production and inspection, among others, of products subject to lot releases. Lot release documents shall be reviewed and issued by the qualified person of an enterprise. | | 批签发产品应当按照食品药品监管总局核准的工艺生产。企业对批签发产品生产、检验等过程中形成的资料、记录和数据的真实性负责。批签发资料应当经企业质量受权人审核并签发。 |
| Before each product lot is marketed or imported, a lot release applicant shall voluntarily apply for a lot release, discharge the statutory obligations in lot release activities in accordance with the law, and ensure the quality reliability of the product under the lot release application and the authenticity of lot release application documents, process recordings, experimental data and samples. | | 每批产品上市销售前或者进口时，批签发申请人应当主动提出批签发申请，依法履行批签发活动中的法定义务，保证申请批签发的产品质量可靠以及批签发申请资料、过程记录、试验数据和样品的真实性。 |
| Article 4 The CFDA shall take charge of the lot release of biological products across the country, be responsible for specifying the scope of varieties requiring lot release, designate lot release institutions, and guide the implementation of the lot release work. | | 第四条 食品药品监管总局主管全国生物制品批签发工作，负责规定批签发品种范围，指定批签发机构，指导批签发工作的实施。 |
| The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the daily regulation of local lot release applicants within their respective administrative regions, assist lot release institutions in conducting on-site verification, organize the on-site sampling of products requiring lot release and disposition of products failing lot release, and investigate and process violations of the laws or regulations discovered in the course of lot release. | | 省、自治区、直辖市食品药品监督管理部门负责本行政区域批签发申请人的日常监管，协助批签发机构开展现场核实，组织批签发产品的现场抽样及批签发不合格产品的处置，对批签发过程中发现的违法违规行为进行调查处理。 |
| Lot release institutions designated by the CFDA shall be responsible for lot release acceptance, document review, on-site verification, sample inspection, and other work and make lot release decisions in accordance with the law. | | 食品药品监管总局指定的批签发机构负责批签发的受理、资料审核、现场核实、样品检验等工作，并依法作出批签发决定。 |
| The CFDA shall authorize the National Institutes for Food and Drug Control (hereinafter referred to as the "NIFDC") to organize and develop technical requirements for lot release and detailed rules for technical appraisals, to conduct ability evaluations and appraisals of drug inspection institutions seeking to undertake lot release work or expand the scope of varieties under lot release, and to provide other lot release institutions with business guidance, technical training and appraisals and evaluations. | | 食品药品监管总局委托中国食品药品检定研究院（以下简称中检院）组织制定批签发技术要求和技术考核细则，对拟承担批签发工作或者扩大批签发品种范围的药品检验机构进行能力评估和考核，对其他批签发机构进行业务指导、技术培训和考核评估。 |
| The CFDA Center for Food and Drug Inspection (hereinafter referred to as the "Inspection Center") shall be responsible for the on-site inspection in the course of lot release. | | 食品药品监管总局食品药品审核查验中心（以下简称核查中心）负责批签发过程中的现场检查工作。 |
| Article 5 The CFDA shall establish a risk-oriented supervision and administration system for products subject to lot release. When necessary, the authenticity and reliability of lot release application documents may be verified through on-site verification. | | 第五条 食品药品监管总局对批签发产品建立基于风险的监督管理体系。必要时，可以通过现场核实验证批签发申请资料的真实性、可靠性。 |
| Article 6 The lot release review and inspection of biological products shall be governed the drug registration standards as confirmed by the CFDA and in conformity with the requirements of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the "Pharmacopoeia"). | | 第六条 生物制品批签发审核、检验应当依据食品药品监管总局核准的药品注册标准，并应当同时符合中华人民共和国药典（以下简称药典）要求。 |
| Chapter II Determination of Lot Release Institutions | | 第二章 批签发机构确定 |
| Article 7 A lot release institution and the varieties subject to lot release it is responsible for shall be determined by the CFDA. | | 第七条 批签发机构及其所负责的批签发品种由食品药品监管总局确定。 |
| The CFDA shall, as needed for the lot release work, issue the selection standards and conditions for new lot release institutions and increases in varieties subject to lot release of lot release institutions. | | 食品药品监管总局根据批签发工作需要，适时公布新增批签发机构及批签发机构扩增批签发品种的遴选标准和条件。 |
| Article 8 A drug inspection institution meeting the selection standards and conditions as self-evaluated may file an application with the food and drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government, and the latter shall conduct a preliminary review and file it with the CFDA. | | 第八条 自评符合遴选标准和条件要求的药品检验机构可以向省、自治区、直辖市食品药品监督管理部门提出申请，省、自治区、直辖市食品药品监督管理部门初步审查后，报食品药品监管总局。 |
| The NIFDC shall conduct capacity evaluations and appraisals of drug inspection institution applicants. The CFDA shall determine based on the appraisal results that the drug inspection institutions undertake the lot release of the corresponding varieties or that the lot release institutions expand the scope of varieties subject to lot release. | | 中检院对提出申请的药品检验机构进行能力评估和考核。食品药品监管总局根据考核结果确定由该药品检验机构承担相应品种的批签发工作，或者对批签发机构扩大批签发品种范围。 |
| Article 9 The NIFDC shall, as needed for the lot release work, evaluate lot release institutions and report the evaluations to the CFDA in a timely manner. | | 第九条 中检院应当根据批签发工作需要，对批签发机构进行评估，评估情况及时报告食品药品监管总局。 |
| Article 10 Where a lot release institution falls under any of the following circumstances, the CFDA shall disqualify the institution for lot release: | | 第十条 批签发机构有下列情形之一的，食品药品监管总局取消该机构批签发资格： |
| (1) A material error arising from subjective reasons occurred, causing serious consequences. | | （一）因主观原因发生重大差错，造成严重后果的； |
| (2) Issuing any false inspection report. | | （二）出具虚假检验报告的； |
| (3) Ceasing to meet lot release institution standards and conditions as evaluated. | | （三）经评估不再具备批签发机构标准和条件要求的。 |
| Chapter III Application for Lot Releases | | 第三章 批签发申请 |
| Article 11 Before initial application for a lot release of a biological product whose marketing is newly approved, a lot release applicant shall make registration and develop archives in the lot release information management system. At registration, the following documents shall be submitted: | | 第十一条 新批准上市的生物制品首次申请批签发前，批签发申请人应当在批签发信息管理系统内登记建档。登记时应当提交以下资料： |
| (1) A biological product variety lot release registration form. | | （一）生物制品批签发品种登记表； |
| (2) Certification documents on drug approval. | | （二）药品批准证明文件； |
| (3) Certification documents on lawful production. | | （三）合法生产的证明性文件。 |
| If the relevant documents meet requirements, the NIFDC shall, within ten days, confirm the registration of a variety under the application in the lot release information management system. | | 相关资料符合要求的，中检院应当在10日内完成所申请品种在批签发信息管理系统内的登记确认。 |
| When registration information is changed, a lot release applicant shall modify it in the lot release information management system in a timely manner. | | 登记信息发生变化时，批签发申请人应当及时在批签发信息管理系统内变更。 |
| Article 12 For each variety whose lot release is to be applied for, the lot release applicant shall create an independent standard summary of lot release production and inspection records, and upon submission of which to the NIFDC, the NIFDC shall distribute it to the lot release institution and the applicant. Where a lot release applicant needs to revise a confirmed standard summary of lot release production and inspection records, it shall file an application with the NIFDC and may conduct modification only upon confirmation of the NIFDC. | | 第十二条 对拟申请批签发的每个品种，批签发申请人应当建立独立的批签发生产及检定记录摘要模板，报中检院核定后，由中检院分发给批签发机构和申请人。批签发申请人需要修订已核定的批签发生产及检定记录摘要模板的，应当向中检院提出申请，经中检院核定后方可变更。 |
| Article 13 A lot release applicant shall, upon production and inspection of the biological product managed according to lot release, fill in the biological product lot release application form in the lot release information management system and, based on the place in which the drug producer that applies for the lot release is located, or in which the port for the planned import is located, apply to the lot release institution in the corresponding place for lot release. | | 第十三条 按照批签发管理的生物制品在生产、检验完成后，批签发申请人应当在批签发信息管理系统内填写生物制品批签发申请表，并根据申请批签发产品的药品生产企业所在地或者拟进口口岸所在地，向相应属地的批签发机构申请批签发。 |
| Article 14 A lot release applicant shall file a sampling application with the food and drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or a sampling institution designated by it with the biological product lot release application form, and sampling personnel shall organize on-site sampling within five days and seal the samples. The lot release applicant shall send the sealed samples under the same conditions to the lot release institution for lot release registration and submit lot release application documents. | | 第十四条 批签发申请人凭生物制品批签发申请表向省、自治区、直辖市食品药品监督管理部门或者其指定的抽样机构提出抽样申请，抽样人员在5日内组织现场抽样，并将所抽样品封存。批签发申请人将封存样品在规定条件下送至批签发机构办理批签发登记，同时提交批签发申请资料。 |
| The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for organizing the sampling of the products subject to lot release produced in or imported to their respective administrative regions, determine relatively fixed sampling institutions and personnel, make recordation at lot release institutions, regularly train sampling institutions and personnel, and supervise and guide sampling work. | | 省、自治区、直辖市食品药品监督管理部门负责组织本行政区域生产或者进口的批签发产品的抽样工作，确定相对固定的抽样机构和人员并在批签发机构备案，定期对抽样机构和人员进行培训，对抽样工作进行督查指导。 |
| Article 15 A lot release applicant shall, when applying for lot release, provide the following certification documents, materials and samples. | | |
| (1) A biological product lot release application form. | | （一）生物制品批签发申请表； |
| (2) Certification documents on drug approval. | | （二）药品批准证明文件； |
| (3) Certification documents on lawful production. | | （三）合法生产的证明性文件； |
| (4) Certification documents on approval on postmarketing modification. | | （四）上市后变更的批准证明性文件； |
| (5) The summary of lot production and inspection records as signed by the qualified person of the drug producer and sealed by the enterprise. | | （五）药品生产企业质量受权人签字并加盖企业公章的批生产及检定记录摘要； |
| (6) For products of the same lot whose quantity satisfies the corresponding variety lot release inspection requirements, when necessary, providing intermediate products, reference materials, reagents and other materials relating to the inspection. | | （六）数量满足相应品种批签发检验要求的同批号产品，必要时提供与检验相关的中间产品、标准物质、试剂等材料； |
| (7) Statements of the change of qualified persons and other key personnel. | | （七）质量受权人等关键人员变动情况的说明； |
| (8) Other documents relating to product quality. | | （八）与产品质量相关的其他资料。 |
| For the import of a vaccine product or blood product, the certificate of origin issued by the country or region in which the producer is located, the certification document on lot release issued by the drug administration authority, and the notarized Chinese translations thereof shall be provided. If an imported product is exempt from lot release in the exporting country, the certification documents on the exemption shall be provided. | | 进口疫苗类制品和血液制品应当同时提交生产企业所在国家或者地区的原产地证明以及药品管理当局出具的批签发证明文件，并提供经公证的中文译本。进口产品在本国免予批签发的，应当提供免予批签发的证明性文件。 |
| The photocopies of the relevant certification documents shall be sealed by an enterprise. | | 相关证明性文件为复印件的，应当加盖企业公章。 |
| "Summary of biological product lot production and inspection records" means a document of brief statement of the whole production technology and process and the inspection results at key links of quality control of a biological product lot. The document shall be reviewed and determined by the quality management department and qualified person of an enterprise. | | 生物制品批生产及检定记录摘要，是指概述某一批生物制品全部生产工艺流程和质量控制关键环节检验结果的文件。该文件应当由企业质量管理部门和质量受权人审核确定。 |
| Article 16 A lot release institution shall conduct verification immediately after receipt of application documents and samples and properly retain them upon registration and signature for confirmation by both parties to the handover. A lot release applicant who is unable to sign on site for confirmation shall submit a written commitment in advance. | | 第十六条 批签发机构收到申请资料及样品后，应当立即核对，交接双方登记签字确认后，妥善保存。批签发申请人无法现场签字确认的，应当提前递交书面承诺。 |
A lot release institution shall decide within five days whether to grant acceptance. If acceptance is granted, a biological product lot release registration form shall be issued; otherwise, the application shall be returned, and a notice of non-acceptance and statements of reasons shall be provided.
．．．．．． | | 批签发机构应当在5日内决定是否受理。同意受理的，出具生物制品批签发登记表；不予受理的，予以退回，发给不予受理通知书并说明理由。
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