Biological Products Batch Release Management Measures

Biological Products Batch Release Management Measures

(2020 December 11th, National Market Supervision Administration Order No. 33 )

 

Chapter 1 General Provisions

　　Article 1 In order to strengthen the supervision and management of biological products, regulate the batch release behavior of biological products, and ensure the safety and effectiveness of biological products, these measures are formulated in accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law") and the "Vaccine Administration Law of the People's Republic of China" (hereinafter referred to as the "Vaccine Administration Law").

　　Article 2 The batch release of biological products referred to in these measures means that the National Medical Products Administration reviews and inspects vaccines, blood products, in vitro diagnostic reagents for blood source screening, and other biological products stipulated by the National Medical Products Administration that have obtained marketing authorization, through designated batch release institutions before each batch of products is marketed or imported, and issues batch release certificates for those that meet the requirements.

　　Products that have not passed batch release shall not be marketed or imported, except for those exempted from batch release with approval from the National Medical Products Administration according to law.

　　Article 3 The batch release applicant shall be the domestic or foreign marketing authorization holder holding the drug approval certificate. Foreign marketing authorization holders shall designate a domestic enterprise legal person in China to handle batch release.

　　Batch release products shall be produced according to the approved process and shall comply with national drug standards and drug registration standards. The entire production process shall comply with the requirements of Good Manufacturing Practice for drugs. The marketing authorization holder shall establish a complete production quality management system and continuously strengthen deviation management. The marketing authorization holder is responsible for the authenticity of the data, records, and information generated during the production and inspection of batch release products. Batch release documents shall be reviewed and signed by the quality authorized person of the marketing authorization holder.

　　Before each batch of products is marketed or imported, the batch release applicant shall proactively submit a batch release application, perform the statutory obligations in the batch release activities according to law, and ensure the reliability of the product quality applied for batch release as well as the authenticity of the application materials and samples.

　　Article 4 The National Medical Products Administration is in charge of the national biological products batch release work, responsible for stipulating the scope of batch release varieties, designating batch release institutions, clarifying batch release work requirements, and guiding the implementation of batch release work.

　　The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the supervision and management of batch release applicants within their administrative regions, organizing on-site inspections of batch release products within their regions; assisting batch release institutions in on-site verification, organizing on-site sampling of batch release products and disposal of unqualified batch release products; investigating and handling major quality risks and illegal acts found during batch release, and promptly notifying batch release institutions of the investigation and handling results; investigating major deviations that may affect product quality during enterprise production and issuing review and evaluation reports; and responsible for the daily management of batch release institutions within their administrative regions.

　　Batch release institutions designated by the National Medical Products Administration are responsible for acceptance, document review, sample inspection, and other work related to batch release, and shall make batch release decisions according to law.

　　The National Institutes for Food and Drug Control (hereinafter referred to as NIFDC) organizes the formulation of batch release technical requirements and technical assessment rules, conducts capability evaluation and assessment of drug testing institutions intending to undertake batch release work or expand the scope of batch release varieties, provides business guidance, technical training, and assessment for other batch release institutions; organizes and coordinates the implementation of batch release work by batch release institutions.

　　The Food and Drug Audit and Inspection Center of the National Medical Products Administration (hereinafter referred to as the Inspection Center) undertakes overseas on-site inspections and other work during the batch release process.

　　Article 5 The National Medical Products Administration establishes a risk-based supervision and management system for batch release products. When necessary, it may verify the authenticity and reliability of batch release application materials through on-site verification.

　　Article 6 The review and inspection of biological products batch release shall be based on national drug standards and drug registration standards.

　 　Chapter 2 Determination of Batch Release Institutions

　　Article 7 Batch release institutions and the varieties they are responsible for shall be determined by the National Medical Products Administration.

　　The National Medical Products Administration shall publish the evaluation criteria, procedures, and conditions for newly added batch release institutions and the expansion of batch release varieties by batch release institutions in a timely manner according to the needs of batch release work.

　　Drug testing institutions may submit relevant materials for undertaking batch release work or expanding batch release varieties to the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government according to the evaluation criteria and conditions. If the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government consider that the batch release institution meets the evaluation criteria, they shall submit an application for batch release institution evaluation to the National Medical Products Administration. NIFDC shall conduct capability evaluation and assessment of the applying drug testing institutions. The National Medical Products Administration shall determine the batch release work for the corresponding varieties to be undertaken by the drug testing institution or agree to the expansion of batch release varieties by the batch release institution based on the assessment results.

　　Article 8 NIFDC shall evaluate batch release institutions according to the needs of batch release work and report the evaluation results to the National Medical Products Administration in a timely manner.

　　Article 9 If a batch release institution has any of the following circumstances, the National Medical Products Administration may require the institution to stop batch release work:

　　(1) Occurrence of major errors causing serious consequences;

　　(2) Issuance of false inspection reports;

　　(3) No longer meeting the evaluation criteria and conditions of batch release institutions after assessment.

　　Chapter 3 Batch Release Application

　　Article 10 Before the first batch release application of newly approved biological products, the batch release applicant shall register and file in the biological products batch release management system. The following materials shall be submitted during registration:

　　(1) Biological products batch release variety registration form;

　　(2) Drug approval certificate;

　　(3) Relevant documents of legal production.

　　If the relevant materials meet the requirements, NIFDC shall complete the registration confirmation of the applied varieties in the biological products batch release management system within 10 days.

　　When registration information changes, the batch release applicant shall promptly update it in the biological products batch release management system.

　　Article 12 For each variety proposed for batch release application, the batch release applicant shall establish an independent batch release production and inspection record summary template. After approval by the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), it shall be distributed by NICPBP to the batch release institutions and applicants. If the batch release applicant needs to revise the approved batch release production and inspection record summary template, an application shall be submitted to NICPBP, and changes can only be made after approval by NICPBP.

　　Article 13 For biological products managed under batch release, after production and inspection are completed, the batch release applicant shall fill in the biological product batch release application form in the biological product batch release management system, and apply for batch release to the batch release institution corresponding to the location of the marketing authorization holder of the product or the proposed import port.

　　Article 14 The batch release applicant shall submit a sampling application to the drug regulatory department of the province, autonomous region, or municipality directly under the central government, or its designated sampling agency, with the biological product batch release application form. Sampling personnel shall organize on-site sampling within 5 days and seal the sampled samples. The batch release applicant shall deliver the sealed samples to the batch release institution under specified conditions for batch release registration, and submit the batch release application materials simultaneously.
　　The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for organizing the sampling work of batch release products produced or imported within their administrative regions. They shall formulate sampling management procedures in accordance with the drug sampling regulations of the National Medical Products Administration, determine relatively fixed sampling agencies and personnel and file them with the batch release institutions, regularly train the sampling agencies and personnel, and supervise and guide the sampling work.
　　
　　Article 15 When applying for batch release, the batch release applicant shall provide the following supporting documents, materials, and samples:

　　(1) Biological product batch release application form;

　　(2) Drug approval certificate;

　　(3) Relevant documents of legal production;

　　(4) Approval or filing documents for post-marketing changes;

　　(5) Summary of batch production and inspection records signed by the quality authorized person and stamped with the company seal;

　　(6) Products of the same batch number meeting the batch release inspection requirements in quantity; if necessary, provide related intermediate products, standard substances, reagents, and other materials related to inspection;

　　(7) Explanation of changes in key personnel such as production management responsible person, quality management responsible person, and quality authorized person;

　　(8) Other materials related to product quality.

　　Applicants for vaccine batch release shall also submit a checklist of production process deviations, quality differences, faults and accidents during production, measures taken, and evaluation conclusions on the impact on vaccine quality; if there are deviations that may affect vaccine quality, a deviation report shall be submitted, including deviation description, handling measures, risk assessment conclusions, corrective and preventive measures taken or planned. For major deviations that may affect quality, an audit and evaluation report from the drug regulatory department of the province, autonomous region, or municipality where the applicant is located shall be provided.

　　Imported vaccine products and blood products shall simultaneously submit the certificate of origin from the country or region of the manufacturer and the batch release certificate issued by the drug regulatory authority. If imported products are exempt from batch release in the country, proof of exemption shall be provided. Relevant supporting documents shall be accompanied by notarized Chinese translations. If the supporting documents are copies, they shall be stamped with the company seal.

　　The summary of biological product batch production and inspection records refers to a document summarizing the entire production process and key quality control inspection results of a batch of biological products. This document shall be reviewed and confirmed by the company's quality management department and quality authorized person.

　　Article 16 After the batch release institution receives the application materials and samples, it shall immediately verify them, and after both parties sign and confirm the handover, properly preserve them. If the batch release applicant cannot sign and confirm on-site, a written commitment shall be submitted in advance.

　　The batch release institution shall decide whether to accept the application within 5 days. If accepted, a batch release acceptance notice shall be issued; if not accepted, the application shall be returned with a notice of non-acceptance and reasons explained.

　　If the application materials are incomplete or do not meet the prescribed format, the batch release institution shall notify the batch release applicant in writing within 5 days in one go of all the contents that need to be corrected and the deadline for correction. If no notification is given within the time limit, the application shall be deemed accepted from the date of receipt of the application materials and samples.

　　After receiving the notice of correction, the batch release applicant shall correct the materials within 10 days. If the correction is not made within the time limit without a valid reason, it shall be deemed as abandonment of the application, and no decision of non-acceptance is required.
　　If there are errors in the application materials that can be corrected on the spot, the batch release applicant shall be allowed to correct them on the spot.

　　If the batch release institution does not accept the application, the applicant shall not apply again to another batch release institution.

　　Article 17 For biological products urgently needed for national disease prevention and control emergencies, enterprises may apply for simultaneous batch release to the batch release institution after completing production with approval from the National Medical Products Administration.

　　Before the batch release institution issues a batch release qualified conclusion, the batch release applicant shall complete and submit the batch release application materials to the batch release institution.

　　Article 18 Vaccines urgently needed for the prevention and control of infectious disease epidemics or emergency response, with approval from the National Medical Products Administration, are exempt from batch release.

 
　　 Chapter 4 Review, Inspection, Examination, and Release

　　Article 19 Vaccine batch release shall be conducted batch by batch with document review and sampling inspection. Other biological product batch releases may be conducted by document review alone or by a combination of document review and sample inspection, and on-site verification may be conducted as needed. The inspection items and inspection ratios for different varieties shall be organized and demonstrated by NICPBP and reported to the National Medical Products Administration. The batch release institution shall conduct inspections according to the determined inspection requirements.

　　During the batch release process for specific varieties, the batch release institution may comprehensively evaluate and dynamically adjust the inspection items and inspection frequency based on the process and quality control maturity of the variety and previous batch release situations. If non-conforming items appear in batch release products, the batch release institution shall increase the inspection frequency of the corresponding items for subsequent batches.

　　Article 20 The content of document review includes:

　　(1) Whether the application materials meet the requirements;

　　(2) Whether the raw and auxiliary materials, strains, toxins, cells, etc. used in production are consistent with those approved by the National Medical Products Administration;

　　(3) Whether the production process and process control are consistent with those approved by the National Medical Products Administration and meet national drug standards requirements;

　　(4) Whether the inspection items, inspection methods, and results of the product raw liquid, semi-finished products, and finished products comply with the requirements of national drug standards and drug registration standards;

　　(5) Whether there are abnormalities in the trend analysis of key product quality indicators;

　　(6) Whether the product packaging, labels, and instructions are consistent with the content approved by the National Medical Products Administration;

　　(7) Risk assessment report on the impact of production process deviations on product quality;

　　(8) Other items that need to be reviewed.

　　Article 21 In any of the following situations, the product shall undergo full item inspection according to the registration standards, and only after at least three consecutive batches of products have passed batch release can partial item inspection be conducted:

　　(1) Products newly approved for marketing by the National Medical Products Administration for the batch release applicant;

　　(2) Changes in the production site that have been approved;

　　(3) Major changes in the production process that have been approved;

　　(4) Products that have not applied for batch release for two consecutive years;

　　(5) Production resumed after being ordered to stop due to violation of relevant laws and regulations, with approval;

　　(6) Information indicating potential risks in the quality or quality control of the corresponding product.

　　Article 22 The batch release agency shall complete the batch release work within the working time limit specified in these measures. The time for the batch release applicant to supplement materials, on-site verification, on-site inspection, and technical evaluation shall not be included in the batch release work time limit.
　　Vaccine products shall complete batch release within 60 days, and blood products and in vitro diagnostic reagents used for blood source screening shall complete batch release within 35 days. If retesting is required, the batch release work time limit may be extended by two inspection cycles of the inspection item, and the batch release applicant shall be informed.

　　If the batch release time limit needs to be extended due to product characteristics and inspection items, it shall be publicly announced after review and confirmation by the National Institute for Food and Drug Control.

　　Article 23 If the batch release agency cannot complete the batch release work within the specified time limit due to force majeure or emergency response to public health incidents, it shall notify the batch release applicant in writing of the extension period, reasons, and expected recovery time. If it is indeed difficult to complete, the National Institute for Food and Drug Control shall coordinate other batch release agencies to undertake the work.

　　Article 24 Under the premise of ensuring the independence of data review and sample inspection and other technical review work, the batch release agency may communicate and verify specific issues that need explanation during the batch release process with the batch release applicant. Verification work can be conducted through telephone communication, written notice, and other forms, and on-site verification can be carried out if necessary. If the batch release applicant is required to provide explanations or supplementary materials, a written notice shall be issued with a clear deadline for response.

　　If the batch release agency needs to further verify the authenticity of the batch release application materials and samples, it shall promptly send personnel to the production enterprise for on-site verification. Measures such as on-site review of original records, on-site inspection of equipment and logs can be taken, and on-site sampling inspection can be conducted as appropriate. On-site verification work shall be carried out in accordance with the relevant requirements for on-site verification of biological product batch release, and the provincial, autonomous region, and municipality drug supervision and administration departments shall be notified to dispatch regulatory enforcement personnel to assist.

　　Article 25 In any of the following situations, the batch release agency shall notify the drug supervision and administration departments of the province, autonomous region, or municipality where the batch release applicant and production site are located, propose on-site inspection suggestions, and copy the National Medical Products Administration:

　　(1) Sterility test failure;

　　(2) Two consecutive batches failing efficacy and other effectiveness indicators;

　　(3) Data review indicating serious problems in product production quality control, or production process deviations, quality differences, faults, and accidents during production requiring further investigation;

　　(4) Possible authenticity issues with batch release application materials or samples;

　　(5) Other situations indicating significant product quality risks.

　　During the investigation and handling of the above issues, acceptance or release of the corresponding varieties by the batch release applicant may be suspended.

　　If the above situations are found during the batch release of imported biological products, the batch release agency shall report to the National Medical Products Administration and propose related suggestions such as on-site inspections.

　　Article 26 After receiving the notification and on-site inspection suggestions from the batch release agency, the drug supervision and administration departments of the province, autonomous region, or municipality shall conduct on-site inspections within 10 days.

　　Within 10 days after the inspection, the drug supervision and administration departments of the province, autonomous region, or municipality shall organize a technical evaluation of the quality risks of the relevant batches of products proposed by the batch release agency and make a clear conclusion; in special cases, the time limit may be appropriately extended with reasons explained. After receiving the notification and on-site inspection suggestions regarding imported products from the batch release agency, the National Medical Products Administration shall promptly organize the verification center to conduct overseas on-site inspections. The time limit for overseas on-site inspections shall be determined according to specific circumstances.

　　The inspection agency shall, based on the risk level and scope found during the inspection, propose risk control recommendations for emergency measures if necessary. The notified drug supervision and administration departments shall inform the batch release agency to refuse or suspend batch release of the relevant or all products of the batch release applicant and order the batch release applicant to rectify.

　　After the batch release applicant clarifies the cause of the problem and completes the rectification, they shall report to the drug supervision and administration department and the batch release agency. After confirmation that the requirements are met, the drug supervision and administration department shall notify the batch release agency to resume batch release.

　　Article 27 If the drug supervision and administration department discovers significant quality risks in biological products during supervision and inspection, it shall promptly notify the batch release agency to refuse or suspend batch release of the relevant products of the drug marketing authorization holder based on the inspection results.

　　Article 28 If the batch release applicant applies to withdraw the batch release, the reason shall be explained, and withdrawal can only be made with the consent of the batch release agency; the batch release applicant shall report the withdrawal of the batch release application to the drug supervision and administration department of the province, autonomous region, or municipality where it is located. If the batch release agency has confirmed defects in data review or non-compliance in inspection results, the batch release applicant shall not withdraw.

　　If non-compliance in inspection results occurs during the synchronous batch release process and withdrawal of batch release is required, the reason shall be explained, and withdrawal can only be made with the consent of the batch release agency.

　　Article 29 The batch release agency shall make a batch release conclusion based on data review, sample inspection, or on-site inspection results. If the requirements are met, a biological product batch release certificate shall be issued, stamped with the special batch release seal, and given to the batch release applicant.

　　The electronic batch release certificate issued by the batch release agency has the same legal effect as the printed batch release certificate.

　　For biological products managed by batch release, a copy of the biological product batch release certificate stamped with the company seal or an electronic file shall be provided when selling the batch product.

　　Article 30 In any of the following circumstances, batch release shall not be granted. A notice of refusal of batch release for the biological product shall be issued to the batch release applicant and copied to the drug regulatory authorities of the province, autonomous region, or municipality where the applicant or the import port is located:

　　(1) Data review does not meet the requirements;

　　(2) Sample inspection fails;
　　(3) On-site verification finds authenticity issues;

　　(4) On-site inspection finds violations of Good Manufacturing Practice for drugs with serious defects;

　　(5) On-site inspection finds systemic or major quality risks in the product;

　　(6) The batch release applicant fails to correct the data within the prescribed time limit without valid reasons;

　　(7) Comprehensive evaluation finds major quality risks;

　　(8) Other circumstances that do not comply with legal and regulatory requirements.

　　Article 31 Biological products that are refused batch release or have their batch release withdrawn shall be supervised for destruction by the drug regulatory authorities of the province, autonomous region, or municipality where they are located according to relevant regulations. Imported biological products refused batch release or withdrawn shall be supervised for destruction by the drug regulatory authorities at the port of entry or handled otherwise according to law.

　　Article 32 If quality problems or other safety hazards are found in enterprise products during batch release work, involving batches already on the market, the batch release agency shall immediately notify the drug regulatory authorities of the province, autonomous region, or municipality where the batch release applicant and production site are located; for imported biological products, the drug regulatory authorities at the import port shall be notified. Upon receiving the notification, the drug regulatory authorities shall immediately inform the batch release applicant.

　　The batch release applicant shall immediately take measures such as stopping sales and use, recalling defective products, and destroy them under the supervision of the drug regulatory authorities according to relevant regulations. The batch release applicant shall report the destruction records to both the drug regulatory authorities and the corresponding batch release agency.

　　The drug regulatory authorities may take measures such as responsibility interviews and rectification within a time limit based on risk assessment.

　　The batch release applicant's recall of products does not exempt them from other legal responsibilities they should bear according to law.

　　Article 33 The batch release agency shall conduct an annual summary of batch release work. After the National Institute for Food and Drug Control compiles and analyzes it, a report shall be submitted to the National Medical Products Administration before the end of March each year.

 

　 　Chapter 5 Reexamination

　　Article 34 If the batch release applicant has objections to the notice of refusal of batch release for biological products, they may apply for reexamination to the original batch release agency or directly to the National Institute for Food and Drug Control within 7 days from the date of receipt of the notice.

　　Article 35 The original batch release agency or the National Institute for Food and Drug Control shall decide whether to conduct the reexamination within 20 days from the date of receipt of the reexamination application from the batch release applicant. The reexamination content is limited to the original application matters and submitted materials. If reinspection is required, the samples shall be those retained by the original batch release agency, and the time limit shall be implemented according to Article 22 of these Measures.

　　Reexamination shall not be granted in any of the following circumstances:

　　(1) Nonconforming items are sterility, pyrogen (bacterial endotoxin), or other items that the drug regulatory authorities stipulate cannot be reexamined;

　　(2) Samples are obviously uneven;

　　(3) Sample validity period does not meet inspection requirements;

　　(4) The batch release applicant has given a written commitment to waive reinspection;

　　(5) The reexamination application is not submitted within the prescribed time limit;

　　(6) Other circumstances unsuitable for reexamination.

　　Article 36 If the reexamination upholds the original decision, a notice of the reexamination result of the biological product batch release shall be issued, and no further reexamination applications from the batch release applicant shall be accepted; if the reexamination changes the original conclusion, the original notice of refusal of batch release shall be withdrawn, and a biological product batch release certificate shall be issued.

 
　　 Chapter 6 Information Disclosure

　　Article 37 The National Medical Products Administration shall establish a unified biological product batch release information platform, publish information such as batch release agencies and adjustments, major issue handling decisions, provide batch release applicants with queryable batch release progress and conclusions, and promptly publish information on products that have passed batch release for public inquiry.

　　The National Institute for Food and Drug Control is responsible for the daily operation and maintenance of the biological product batch release information platform.

　　Article 38 Batch release agencies shall disclose information such as batch release application procedures, the directory of batch release materials to be submitted, sample application forms, and time requirements on their websites or application acceptance locations.

　　Article 39 For products that have passed batch release, the batch release agency shall disclose information such as product name, batch number, company, expiration date, and batch release certificate number within 7 days.

 

　 　Chapter 7 Legal Liability

　　Article 40 If the drug regulatory authorities, batch release agencies, verification centers, and their staff have any of the following circumstances during batch release work, the directly responsible supervisors and other directly responsible personnel shall be punished according to law; if a crime is constituted, criminal responsibility shall be pursued according to law:

　　(1) Making a batch release conclusion approving applications that do not meet legal conditions or making batch release conclusions beyond legal authority;

　　(2) Making a batch release conclusion refusing applications that meet legal conditions;

　　(3) Violating procedural requirements during batch release, privately disclosing related work information to the batch release applicant or third parties, causing serious consequences;

　　(4) Accepting or soliciting property or other benefits from the batch release applicant during the batch release process;

　　(5) Failure to conduct on-site inspections as required.

　　Article 41 If the batch release institution issues false inspection reports while undertaking batch release-related work, it shall be punished in accordance with Article 138 of the "Drug Administration Law."

　　Article 42 If the batch release applicant provides false information or samples, or deliberately conceals major changes affecting product quality to fraudulently obtain the biological product batch release certificate, it shall be punished in accordance with Article 123 of the "Drug Administration Law."

　　Providing false data, information, samples, or engaging in other deceptive acts when applying for vaccine batch release shall be punished in accordance with Article 81 of the "Vaccine Administration Law."

　　Forging biological product batch release certificates shall be punished in accordance with Article 122 of the "Drug Administration Law."

　　Article 43 Selling or using biological products without obtaining a biological product batch release certificate shall be punished in accordance with Article 124 of the "Drug Administration Law."

 

　 　Chapter 8 Supplementary Provisions

　　Article 44 The time limits stipulated in these Measures are calculated in working days, excluding statutory holidays.

　　Article 45 Biological products subject to batch release management must also comply with relevant laws and regulations on drug importation. For biological products designated by the National Medical Products Administration for batch release, the biological product batch release certificate can serve as proof of product qualification for customs clearance.

　　Exported vaccines shall meet the standards or contractual requirements of the importing country (region) and may apply for batch release according to the standards or contractual requirements of the importing country (region).

　　Article 46 The National Medical Products Administration is responsible for issuing and updating the special seal for batch release institutions. The biological product batch release special seal is named "National Batch Release Institution Special Seal (X)." Here, X represents the abbreviation of the batch release institution.

　　The formats of the Biological Product Batch Release Application Form, Biological Product Batch Release Registration Form, Biological Product Batch Release Certificate, Notice of Non-Approval for Biological Product Batch Release, Biological Product Batch Release Re-examination Application Form, and Biological Product Batch Release Re-examination Result Notice are uniformly formulated and published by the National Institute for Food and Drug Control.

　　The Biological Product Batch Release Certificate, Notice of Non-Approval for Biological Product Batch Release, and Biological Product Batch Release Re-examination Result Notice are uniformly stamped with the biological product batch release special seal.

　　Article 47 The Biological Product Batch Release Certificate, Notice of Non-Approval for Biological Product Batch Release, and Biological Product Batch Release Re-examination Result Notice shall be sequentially numbered by the batch release institution according to the regulations of the National Medical Products Administration. Their format is "Batch Release X (Import) Inspection XXXXXXXX ", where the initial X symbol represents the abbreviation of the province, autonomous region, municipality, or institution where the batch release institution is located; imported biological products use the character "Import"; the following 8 X symbols: the first 4 digits represent the Gregorian year, and the last 4 digits represent the sequence number within the year.

　　Article 48 These Measures shall come into effect on March 1, 2021. The "Measures for the Administration of Biological Product Batch Release" promulgated by the former State Food and Drug Administration Order No. 39 on December 29, 2017, shall be repealed simultaneously. 年12月29日原国家食品药品监督管理总局令第39号公布的《生物制品批签发管理办法》同时废止。