| | |
| Order of the State Administration for Market Regulation | | 國家市場監督管理總局令 |
| (No. 33) | | （第33號） |
| The Measures for the Administration of Lot Release of Biological Products, as deliberated and adopted at the 11th executive meeting in 2020 of the State Administration for Market Regulation on November 19, 2020, are hereby issued, and shall come into force on March 1, 2021. | | 《生物制品批簽發管理辦法》已于2020年11月19日經國家市場監督管理總局2020年第11次局務會議審議通過，現予公布，自2021年3月1日起施行。 |
| Zhang Gong, Director | | 局長 張工 |
| December 11, 2020 | | 2020年12月11日 |
| Measures for the Administration of Lot Release of Biological Products | | 生物制品批簽發管理辦法 |
| (Issued by Order No. 33 of the State Administration for Market Regulation on December 11, 2020) | | （2020年12月11日國家市場監督管理總局令第33號公布） |
| Chapter I General Provisions | | 第一章 總 則 |
| 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 Medical Products Administration Law of the People's Republic of China (hereinafter referred to as the "Medical Products Administration Law") and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the "Vaccine Administration Law"). | | 第一條 為了加強生物制品監督管理，規範生物制品批簽發行為，保證生物制品安全、有效，根據《中華人民共和國藥品管理法》（以下簡稱《藥品管理法》）、《中華人民共和國疫苗管理法》（以下簡稱《疫苗管理法》）有關規定，制定本辦法。 |
| Article 2 For the purpose of these Measures, "lot release of biological products" means the activities that for vaccine products, blood products, in vitro diagnostics for blood screening, or any other biological products as specified by the National Medical Products Administration ("NMPA") which are authorized for marketing, the NMPA issues a lot release certificate for each lot of products which are found to comply with requirements upon examination and inspection by a designated lot release institution, before the marketing or import of each lot of products. | | 第二條 本辦法所稱生物制品批簽發，是指國家藥品監督管理局對獲得上市許可的疫苗類制品、血液制品、用于血源篩查的體外診斷試劑以及國家藥品監督管理局規定的其他生物制品，在每批產品上市銷售前或者進口時，經指定的批簽發機構進行審核、檢驗，對符合要求的發給批簽發證明的活動。 |
| Any product lot not released may not be marketed or imported, unless the product is exempt from lot release with the approval of the NMPA according to the law. | | 未通過批簽發的產品，不得上市銷售或者進口。依法經國家藥品監督管理局批准免予批簽發的產品除外。 |
| Article 3 A lot release applicant shall be a domestic or overseas drug marketing authorization holder holding supporting documents on drug approval. An overseas drug marketing authorization holder shall designate a domestic enterprise legal person in the territory of China to apply for lot release. | | 第三條 批簽發申請人應當是持有藥品批准證明文件的境內外藥品上市許可持有人。境外藥品上市許可持有人應當指定我國境內企業法人辦理批簽發。 |
| A product subject to lot release shall be produced according to the confirmed process and comply with the national drug standards and drug registration standards. The whole process of production shall meet the requirements of the Good Manufacturing Practices for Drugs. A drug marketing authorization holder shall establish a complete good production practices system and continue to strengthen deviation management. A drug marketing authorization holder shall be responsible for the authenticity of materials, records, and data generated in the process of production and inspection, among others, of products subject to lot release. Lot release materials shall be examined and released by the qualified person of the drug marketing authorization holder. | | 批簽發產品應當按照經核准的工藝生產，並應當符合國家藥品標准和藥品注冊標准。生產全過程應當符合藥品生產質量管理規範的要求。藥品上市許可持有人應當建立完整的生產質量管理體系，持續加強偏差管理。藥品上市許可持有人對批簽發產品生產、檢驗等過程中形成的資料、記錄和數據的真實性負責。批簽發資料應當經藥品上市許可持有人的質量受權人審核並簽發。 |
| Before the marketing or at the time of import of each lot of product, a lot release applicant shall voluntarily apply for 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 materials and samples. | | 每批產品上市銷售前或者進口時，批簽發申請人應當主動提出批簽發申請，依法履行批簽發活動中的法定義務，保證申請批簽發的產品質量可靠以及批簽發申請資料和樣品的真實性。 |
| Article 4 The NMPA shall take charge of the lot release of biological products across the country and be responsible for defining the scope of varieties subject to lot release, designating lot release institutions, specifying the requirements for lot release work, and guiding the implementation of the lot release work. | | 第四條 國家藥品監督管理局主管全國生物制品批簽發工作，負責規定批簽發品種範圍，指定批簽發機構，明確批簽發工作要求，指導批簽發工作的實施。 |
| The medical products administrations of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the supervision and administration of lot release applicants in their respective administrative areas and for organizing the on-site check of products subject to lot release in their administrative areas; assist lot release institutions in conducting on-site verification, organize the on-site sampling of products subject to lot release and disposition of products failing lot release, investigate and handle major quality risks and violations of laws or regulations discovered in the course of lot release, and promptly notify lot release institutions of the results of the investigation and handling; investigate major deviations that may affect product quality in the production process of enterprises and issue examination and assessment reports; and be responsible for the routine administration of lot release institutions in their respective administrative areas. | | 省、自治區、直轄市藥品監督管理部門負責本行政區域批簽發申請人的監督管理，負責組織對本行政區域內批簽發產品的現場檢查；協助批簽發機構開展現場核實，組織批簽發產品的現場抽樣及批簽發不合格產品的處置，對批簽發過程中發現的重大質量風險及違法違規行為進行調查處理，並將調查處理結果及時通知批簽發機構；對企業生產過程中出現的可能影響產品質量的重大偏差進行調查，並出具審核評估報告；負責本行政區域內批簽發機構的日常管理。 |
| Lot release institutions designated by the NMPA shall be responsible for lot release acceptance, examination of materials, inspection of samples, and other work and make lot release decisions in accordance with the law. | | 國家藥品監督管理局指定的批簽發機構負責批簽發的受理、資料審核、樣品檢驗等工作，並依法作出批簽發決定。 |
| The National Institutes for Food and Drug Control (hereinafter referred to as the "NIFDC") shall organize the formulation of technical requirements for lot release and detailed rules for technical assessment, assess and evaluate the capability of drug inspection institutions that propose to undertake lot release work or expand the scope of varieties subject to lot release, and provide business guidance and technical training for, evaluate and assess other lot release institutions; and organize and coordinate the implementation of the lot release work by lot release institutions. | | 中國食品藥品檢定研究院（以下簡稱中檢院）組織制定批簽發技術要求和技術考核細則，對擬承擔批簽發工作或者擴大批簽發品種範圍的藥品檢驗機構進行能力評估和考核，對其他批簽發機構進行業務指導、技術培訓和考核評估；組織協調批簽發機構批簽發工作的實施。 |
| The Center for Food and Drug Inspection of NMPA (hereinafter referred to as the "Inspection Center") shall be responsible for overseas on-site checks and other work in the process of lot release. | | 國家藥品監督管理局食品藥品審核查驗中心（以下簡稱核查中心）承擔批簽發過程中的境外現場檢查等工作。 |
| Article 5 The NMPA shall establish a risk-based supervision and administration system for products subject to lot release. When necessary, the authenticity and reliability of lot release application materials may be verified through on-site verification. | | 第五條 國家藥品監督管理局對批簽發產品建立基于風險的監督管理體系。必要時，可以通過現場核實驗證批簽發申請資料的真實性、可靠性。 |
| Article 6 The examination and inspection in the lot release of biological products shall be based on national drug standards and drug registration standards. | | 第六條 生物制品批簽發審核、檢驗應當依據國家藥品標准和藥品注冊標准。 |
| Chapter II Determination of Lot Release Institutions | | 第二章 批簽發機構確定 |
| Article 7 A lot release institution and the varieties subject to lot release it is responsible for shall be determined by the NMPA. | | 第七條 批簽發機構及其所負責的批簽發品種由國家藥品監督管理局確定。 |
| The NMPA shall, as needed for the lot release work, issue the selection standards, procedures, and conditions for new lot release institutions and expansion of varieties subject to lot release by lot release institutions. | | 國家藥品監督管理局根據批簽發工作需要，適時公布新增批簽發機構及批簽發機構擴增批簽發品種的評定標准、程序和條件。 |
| Article 8 A drug inspection institution may submit to the medical products administration of a province, autonomous region, or municipality directly under the Central Government the work documents related to undertaking the lot release work or expanding varieties subject to lot release, as required by the selection standards and conditions. If the medical products administration of the province, autonomous region, or municipality directly under the Central Government deems that the standards for selection of lot release institutions are met, it shall submit an application for lot release institution assessment to the NMPA. The NIFDC shall assess and evaluate the capability of the drug inspection institution that submits the application. The NMPA shall, based on the evaluation results, determine that the drug inspection institution undertakes the lot release of corresponding varieties, or approve the lot release institution's expansion of the scope of varieties subject to lot release. | | 第八條 藥品檢驗機構可以按照評定標准和條件要求向省、自治區、直轄市藥品監督管理部門提交承擔批簽發工作或者擴增批簽發品種的相關工作材料。省、自治區、直轄市藥品監督管理部門審查認為符合批簽發機構評定標准的，向國家藥品監督管理局提出批簽發機構評估申請。中檢院對提出申請的藥品檢驗機構進行能力評估和考核。國家藥品監督管理局根據考核結果確定由該藥品檢驗機構承擔相應品種的批簽發工作，或者同意該批簽發機構擴大批簽發品種範圍。 |
| Article 9 The NIFDC shall, as needed for the lot release work, assess lot release institutions and report the assessment to the NMPA in a timely manner. | | 第九條 中檢院應當根據批簽發工作需要，對批簽發機構進行評估，評估情況及時報告國家藥品監督管理局。 |
| Article 10 Where a lot release institution falls under any of the following circumstances, the NMPA may require the institution to stop its lot release work: | | 第十條 批簽發機構有下列情形之一的，國家藥品監督管理局可以要求該機構停止批簽發工作： |
| (1) Making a major error, leading to serious consequences. | | （一）發生重大差錯、造成嚴重後果的； |
| (2) Issuing any false inspection report. | | （二）出具虛假檢驗報告的； |
| (3) Ceasing to meet lot release institution selection standards and conditions as assessment. | | （三）經評估不再具備批簽發機構評定標准和條件要求的。 |
| Chapter III Lot Release Applications | | 第三章 批簽發申請 |
| Article 11 Before an initial application for lot release of a biological product of which the marketing is newly approved, a lot release applicant shall register and create records in the biological product lot release management system. At the time of registration, the following materials shall be submitted: | | 第十一條 新批准上市的生物制品首次申請批簽發前，批簽發申請人應當在生物制品批簽發管理系統內登記建檔。登記時應當提交以下資料： |
| (1) A biological product variety lot release registration form. | | （一）生物制品批簽發品種登記表； |
| (2) Supporting documents on drug approval. | | （二）藥品批准證明文件； |
| (3) Documents related to lawful production. | | （三）合法生產的相關文件。 |
| If the relevant materials meet requirements, the NIFDC shall, within ten days, complete the confirmation of registration of the variety under the application in the biological product lot release management system. | | 相關資料符合要求的，中檢院應當在10日內完成所申請品種在生物制品批簽發管理系統內的登記確認。 |
| When registration information is changed, a lot release applicant shall make modification in the biological product lot release management system in a timely manner. | | 登記信息發生變化時，批簽發申請人應當及時在生物制品批簽發管理系統內變更。 |
| Article 12 For each variety of which an application for lot release is proposed, the lot release applicant shall create and submit to the NIFDC for confirmation an independent model summary of lot release production and inspection records, which, as confirmed, shall be distributed by the NIFDC to the lot release institution and the applicant. Where a lot release applicant needs to revise a confirmed model summary of lot release production and inspection records, it shall file an application with the NIFDC, and may make modification only upon confirmation by the NIFDC. | | 第十二條 對擬申請批簽發的每個品種，批簽發申請人應當建立獨立的批簽發生產及檢驗記錄摘要模板，報中檢院核定後，由中檢院分發給批簽發機構和申請人。批簽發申請人需要修訂已核定的批簽發生產及檢驗記錄摘要模板的，應當向中檢院提出申請，經中檢院核定後方可變更。 |
| Article 13 A lot release applicant shall, after the completion of production and inspection of a biological product managed according to lot release, fill in the application form for lot release of a biological product in the biological product lot release management system and based on the establishment of lot release institutions in the place in which the drug marketing authorization holder that applies for lot release is located, or in which the proposed port of import is located, apply for lot release to the lot release institution in the corresponding place. | | 第十三條 按照批簽發管理的生物制品，批簽發申請人在生產、檢驗完成後，應當在生物制品批簽發管理系統內填寫生物制品批簽發申請表，並根據申請批簽發產品的藥品上市許可持有人所在地或者擬進口口岸所在地批簽發機構設置情況，向相應屬地的批簽發機構申請批簽發。 |
| Article 14 A lot release applicant shall file a sampling application with the medical products administration of a province, autonomous region, or municipality directly under the Central Government or a sampling institution designated by it with the application form for lot release of a biological product, 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 prescribed conditions to the lot release institution for lot release registration and submit lot release application materials. | | 第十四條 批簽發申請人憑生物制品批簽發申請表向省、自治區、直轄市藥品監督管理部門或者其指定的抽樣機構提出抽樣申請，抽樣人員在5日內組織現場抽樣，並將所抽樣品封存。批簽發申請人將封存樣品在規定條件下送至批簽發機構辦理批簽發登記，同時提交批簽發申請資料。 |
| The medical products administrations 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 manufactured in or imported to their respective administrative areas, formulating sampling management procedures in accordance with the drug sampling rules of the NMPA, determining relatively fixed sampling institutions and personnel that make filings with lot release institutions, regularly training sampling institutions and personnel, and supervising, inspecting and guiding sampling work. | | 省、自治區、直轄市藥品監督管理部門負責組織本行政區域生產或者進口的批簽發產品的抽樣工作，按照國家藥品監督管理局藥品抽樣規定制定抽樣管理程序，確定相對固定的抽樣機構和人員並在批簽發機構備案，定期對抽樣機構和人員進行培訓，對抽樣工作進行督查指導。 |
| Article 15 A lot release applicant shall, when applying for lot release, provide the following supporting documents, materials, and samples. | | 第十五條 批簽發申請人申請批簽發時，應當提供以下證明性文件、資料及樣品： |
| (1) An application form for lot release of a biological product. | | （一）生物制品批簽發申請表； |
| (2) Supporting documents on drug approval. | | （二）藥品批准證明文件； |
| (3) Documents related to legal production. | | （三）合法生產的相關文件； |
| (4) Approval or filing documents for post-marketing modification. | | （四）上市後變更的批准或者備案文件； |
| (5) The summary of lot production and inspection records as signed by the qualified person and sealed by the enterprise. | | （五）質量受權人簽字並加蓋企業公章的批生產及檢驗記錄摘要； |
| (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）數量滿足相應品種批簽發檢驗要求的同批號產品，必要時提供與檢驗相關的中間產品、標准物質、試劑等材料； |
| (7) An explanation of changes in key personnel such as persons in charge of production management and qualified persons. | | （七）生產管理負責人、質量管理負責人、質量受權人等關鍵人員變動情況的說明； |
| (8) Other materials relating to product quality. | | （八）與產品質量相關的其他資料。 |
| For an application for lot release of vaccine, the lot release applicant shall also submit deviations in the production process for vaccine, quality differences, faults and accidents in the production process, and the records and list of measures taken, the assessment conclusion on the effect on vaccine quality, and a deviation report, including a description of deviations, treatment measures, the conclusion of risk assessment, corrective and preventive measures taken or proposed, if the vaccine quality may be affected. For a major deviation that may affect quality, the lot release applicant shall submit an examination and assessment report by the medical products administration of the province, autonomous region, or municipality directly under the Central Government in the place where the lot release applicant is located. | | 申請疫苗批簽發的，還應當提交疫苗的生產工藝偏差、質量差異、生產過程中的故障和事故以及采取措施的記錄清單和對疫苗質量影響的評估結論；可能影響疫苗質量的，還應當提交偏差報告，包括偏差描述、處理措施、風險評估結論、已采取或者計劃采取的糾正和預防措施等。對可能影響質量的重大偏差，應當提供所在地省、自治區、直轄市藥品監督管理部門的審核評估報告。 |
| ．．．．．． | | 進口疫苗類制品和血液制品應當同時提交生產企業所在國家或者地區的原產地證明以及藥品管理當局出具的批簽發證明文件。進口產品在本國免予批簽發的，應當提供免予批簽發的證明性文件。相關證明性文件應當同時提供經公證的中文譯本。相關證明性文件為複印件的，應當加蓋企業公章。 |
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