Measures for the Administration of the Batch Issuance of Biological Products

Measures for the Administration of the Batch Issuance of Biological Products

(Promulgated by Decree No. 33 of the State Administration of Market Supervision and Administration on December 11, 2020)

 

Chapter I General Provisions

Article 1 In order to strengthen the supervision and administration of biological products, regulate the approval and issuance of biological products, and ensure the safety and effectiveness of biological products, these Measures are formulated 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) and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law).
Article 2 The term "batch issuance of biological products" as mentioned in these Measures refers to the activities of the SDA to review and inspect the vaccine products, blood products, in vitro diagnostic reagents for blood source screening and other biological products specified by the SDA that have been approved for marketing, and to issue batch issuance certificates to those that meet the requirements before each batch of products is marketed or imported.
Products that have not been approved and issued shall not be marketed or imported. Except for products exempted from approval and issuance by the State Drug Administration according to law.
Article 3 The applicant for approval and issuance shall be the holder of the domestic and foreign drug marketing license with the drug approval certificate. The holder of the overseas drug marketing license shall designate the domestic enterprise legal person to handle the approval and issuance.
The approved products shall be produced according to the approved process and shall conform to the national drug standards and drug registration standards. The whole production process shall meet the requirements of the Good Manufacturing Practice for Drugs. The holder of the drug marketing license shall establish a complete production quality management system and continuously strengthen the deviation management. The holder of the drug marketing license shall be responsible for the authenticity of the materials, records and data formed during the production and inspection of the approved products. The approval and issuance materials shall be examined and issued by the quality authorized person of the holder of the drug marketing license.
Before each batch of products is put on the market or imported, the batch issuance applicant shall actively apply for batch issuance, fulfill the legal obligations in the batch issuance activities according to law, and ensure the reliable quality of the products applied for batch issuance and the authenticity of the batch issuance application materials and samples.
Article 4 The SDA shall be in charge of the issuance of biological products in batches throughout the country, be responsible for specifying the range of varieties to be issued in batches, designating the issuing institutions, specifying the requirements for the issuance of biological products in batches, and guiding the implementation of the issuance of biological products in batches.
The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of the applicants for approval and issuance within their respective administrative regions, and shall be responsible for organizing on-site inspections of the products approved and issued within their respective administrative regions; Assist the batch issuing authority to carry out on-site verification, organize on-site sampling of batch issued products and disposal of batch issued nonconforming products, investigate and deal with major quality risks and violations found in the batch issuing process, and timely notify the batch issuing authority of the investigation and handling results; Investigate the major deviations that may affect the product quality in the production process of the enterprise, and issue the audit and evaluation report; To be responsible for the daily management of the approval and issuance institutions in their respective administrative regions.
The agency designated by the SDA shall be responsible for the acceptance, review of materials, sample inspection, etc. of the approval, and shall make the approval decision according to law.
The China Institute for Food and Drug Control (hereinafter referred to as the "CIFDC") organizes the formulation of technical requirements and technical assessment rules for batch issuance, evaluates and assesses the capacity of drug inspection institutions that plan to undertake batch issuance or expand the range of batch issuance varieties, and conducts business guidance, technical training, assessment and evaluation for other batch issuance institutions; Organize and coordinate the implementation of approval and issuance by approval and issuance agencies.
The Food and Drug Audit and Inspection Center of the State Drug Administration (hereinafter referred to as the "Inspection Center") is responsible for overseas on-site inspection during the process of batch issuance.
Article 5 The SDA shall establish a risk-based supervision and management system for the approved and issued products. If necessary, the authenticity and reliability of the batch issuance application materials can be verified through on-site verification.
Article 6 The examination, verification and inspection of the issuance of biological products shall be based on the national drug standards and drug registration standards.

　　Chapter II Determination of Issuing Authority

Article 7 The SDA shall determine the approval and issuance institutions and the approval and issuance varieties they are responsible for.
The SDA shall, in accordance with the needs of batch issuance, timely publish the evaluation standards, procedures and conditions for new batch issuing institutions and for the expanded batch issuing varieties of batch issuing institutions.
Article 8 A drug inspection institution may, in accordance with the requirements of the evaluation standards and conditions, submit to the drug regulatory department of a province, autonomous region or municipality directly under the Central Government the relevant work materials for undertaking the work of issuing batches or expanding the varieties issued in batches. If the drug regulatory department of a province, autonomous region or municipality directly under the Central Government considers that it meets the evaluation criteria for the approval and issuance agency after examination, it shall submit an application to the SDA for evaluation of the approval and issuance agency. CIIC shall evaluate and assess the capabilities of the drug inspection institutions that have submitted applications. The SDA shall, according to the assessment results, determine that the drug inspection institution shall be responsible for the approval and issuance of the corresponding varieties, or agree that the approval and issuance institution shall expand the scope of the approved and issued varieties.
Article 9 The Chinese People's Procuratorate shall, according to the needs of the approval and issuance work, evaluate the approval and issuance institutions, and report the evaluation to the SDA in a timely manner.
Article 10 In any of the following circumstances, the SDA may require an approval and issuance agency to stop the approval and issuance work:
（1） Major errors occur, causing serious consequences;
（2） Issuing false inspection reports;
（3） After assessment, it no longer meets the requirements of the assessment standards and conditions of the issuing authority.

　　Chapter III Application for Batch Issuance

Article 11 Before the first application for approval and issuance of biological products newly approved for listing, the applicant for approval and issuance shall register and file in the management system for approval and issuance of biological products. The following materials shall be submitted at the time of registration:
（1） Registration form of biological products issued in batches;
（2） Drug approval documents;
（3） Relevant documents of legal production.
If the relevant materials meet the requirements, CIDI shall complete the registration confirmation of the applied varieties in the biological product batch issuance management system within 10 days.
In case of any change in the registration information, the applicant for batch issuance shall timely change it in the management system for batch issuance of biological products.
Article 12 For each variety to be applied for batch issuance, the batch issuance applicant shall establish an independent template for the summary of batch issuance production and inspection records, which shall be distributed to the batch issuance institution and the applicant after being approved by the CIDI. If the batch issuing applicant needs to revise the approved template of the batch issuing production and inspection record summary, he/she shall apply to the China National Inspection Institute for approval before changing.
Article 13 For biological products under the administration of batch issuance, the applicant for batch issuance shall, after the completion of production and inspection, fill in the application form for batch issuance of biological products in the system for batch issuance of biological products, and apply for batch issuance to the batch issuance authority of the corresponding territory according to the location of the holder of the drug marketing license applying for batch issuance or the location of the proposed import port.
Article 14 The applicant for batch issuance shall, on the strength of the application form for batch issuance of biological products, submit an application for sampling to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government or its designated sampling agency. The sampling personnel shall organize on-site sampling within 5 days and seal up the sampled samples. The batch issuing applicant shall send the sealed samples to the batch issuing authority for batch issuing registration under the specified conditions, and submit the application materials for batch issuing.
The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for organizing the sampling of batch issued products produced or imported in their respective administrative regions, formulating sampling management procedures in accordance with the provisions of the State Drug Administration on drug sampling, determining relatively fixed sampling institutions and personnel and putting them on record in the batch issuing institutions, regularly training the sampling institutions and personnel, and supervising and guiding the sampling work.
Article 15 When applying for approval of issuance, the applicant for approval of issuance shall provide the following supporting documents, materials and samples:
（1） Application Form for Issuing Biological Products;
（2） Drug approval documents;
（3） Relevant documents of legal production;
（4） Approval or filing documents for changes after listing;
（5） Summary of batch production and inspection records signed by the quality authorized person and affixed with the official seal of the enterprise;
（6） The quantity of products of the same batch number that meet the requirements for issuing inspection of corresponding varieties and batches, and if necessary, provide intermediate products, reference materials, reagents and other materials related to inspection;
（7） Description of changes of key personnel such as production management principal, quality management principal and quality authorized person;
（8） Other data related to product quality.
When applying for the issuance of vaccine batches, the applicant shall also submit a record list of vaccine production process deviations, quality differences, failures and accidents in the production process, measures taken, and evaluation conclusions on the impact of vaccine quality; If the vaccine quality may be affected, a deviation report shall also be submitted, including deviation description, handling measures, risk assessment conclusions, corrective and preventive measures taken or planned to be taken, etc. For major deviations that may affect the quality, the examination and evaluation report of the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the company is located shall be provided.
For the import of vaccine products and blood products, the certificate of origin of the country or region where the manufacturer is located and the certificate of approval issued by the drug administration shall be submitted at the same time. If the imported products are exempted from approval and issuance in the country, the supporting documents of exemption from approval and issuance shall be provided. The notarized Chinese translation of relevant supporting documents shall also be provided. If the relevant supporting documents are photocopies, they shall be affixed with the official seal of the enterprise.
The summary of batch production and inspection records of biological products refers to the document summarizing the inspection results of all production processes and key links of quality control of a batch of biological products. The document shall be reviewed and determined by the quality management department of the enterprise and the quality authorized person.
Article 16 After receiving the application materials and samples, the batch issuing authority shall immediately check them, and properly keep them after the handover parties have registered and signed for confirmation. If the applicant for batch issuance cannot sign for confirmation on site, he/she shall submit a written commitment in advance.
The issuing authority shall decide whether to accept the application within 5 days. If the acceptance is approved, a notice of acceptance issued in batches shall be issued; If the application is not accepted, it shall be returned and a notice of rejection shall be issued with reasons.
If the application materials are incomplete or do not conform to the prescribed form, the approval issuing authority shall, within 5 days, inform the approval issuing applicant in written form of all the contents that need to be supplemented and corrected and the time limit for supplementing and correcting the materials. If no notice is given within the time limit, the application shall be accepted as of the date of receipt of the application materials and samples.
After receiving the notice of supplement and correction of materials, the applicant for approval of issuance shall supplement and correct the materials within 10 days. If the applicant fails to do so within the time limit and has no justifiable reasons, it shall be deemed to have abandoned the application and need not make a decision of rejection.
If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot.
If the application is not accepted by the issuing authority, it shall not be applied for again by changing to another issuing authority.
Article 17 With respect to the biological products needed by the state for emergency disease prevention and control, the enterprises can apply to the approval authority for simultaneous approval and issuance after the completion of production after the approval of the SDA.
Before the approval issuing authority makes a conclusion on the qualification of approval, the applicant for approval issuing shall supplement and complete the application materials for approval issuing and submit them to the approval issuing authority.
Article 18 Vaccines needed urgently to prevent and control the epidemic situation of infectious diseases or respond to emergencies shall be exempted from approval and issuance upon approval by the SDA.

 
　　Chapter IV Audit, Inspection, Inspection and Issuing

Article 19 Batch issuance of vaccines shall be subject to data review and sampling inspection batch by batch. Batch issuance of other biological products may be conducted in the form of data review or in the form of combination of data review and sample inspection, and on-site verification may be conducted as required. For the inspection items and inspection proportion of different varieties, CIIC is responsible for organizing the demonstration and submitting a copy to the SDA. The batch issuing authority shall inspect according to the determined inspection requirements.
In the process of issuing batches of specific varieties, the batch issuing authority can conduct a comprehensive evaluation based on the technology and quality control maturity of the varieties and previous batch issuing, and dynamically adjust the inspection items and frequency of the varieties. In case of any unqualified items of the batch issued products, the batch issuing authority shall increase the inspection frequency for the corresponding items of the subsequent batches of products.
Article 20 The content of data review includes:
（1） Whether the contents of the application materials meet the requirements;
（2） Whether the raw and auxiliary materials, strains, virus strains and cells for production are consistent with those approved by the SDA;
（3） Whether the production process and process control are consistent with those approved by the State Drug Administration and meet the requirements of the national drug standards;
（4） Whether the inspection items, methods and results of the product stock solution, semi-finished products and finished products meet the requirements of the national drug standards and drug registration standards;
（5） Whether the trend analysis of product key quality indicators is abnormal;
（6） Whether the product packaging, labels and instructions are consistent with the contents approved by the State Drug Administration;
（7） Risk assessment report on the impact of production process deviation on product quality;
（8） Other items to be reviewed.
Article 21 Under any of the following circumstances, all items of products shall be inspected in accordance with the registration standards, and only after at least three consecutive batches of products have been issued and qualified, can some items be inspected:
（1） To approve and issue the applicant's new products approved for marketing by the State Drug Administration;
（2） The production site is changed and approved;
（3） The production process has undergone major changes and has been approved;
（4） The product has not applied for approval and issuance for two consecutive years;
（5） Production is resumed after being ordered to stop production due to violation of relevant laws and regulations;
（6） There is information indicating that there may be potential risks in the quality or quality control of corresponding products.
Article 22 Approval issuing institutions shall complete the approval issuing work within the working time limit specified in these Measures. The time for the applicant to supplement and correct the materials, on-site verification, on-site inspection and technical evaluation shall not be included in the time limit for batch issuance.
Vaccine products shall be issued in batches within 60 days, and blood products and in vitro diagnostic reagents for blood source screening shall be issued in batches within 35 days. If re examination is required, the time limit for batch issuing can extend two inspection cycles of the inspection item and inform the batch issuing applicant.
If it is really necessary to extend the time limit for batch issuance due to the variety characteristics and inspection items, it shall be disclosed after being reviewed and determined by the China National Inspection Institute.
Article 23 Where an approval issuing institution is unable to complete the approval issuing work within the prescribed time limit due to force majeure or emergency response to public health emergencies, it shall notify the applicant of approval issuing in writing of the time limit for extension of approval issuing, the reasons and the expected recovery time. If it is really difficult to complete, the China Inspection Institute shall coordinate with other batch issuing agencies to undertake.
Article 24 On the premise of ensuring the independence of the technical review work such as data review and sample inspection, the batch issuing authority can communicate and verify with the batch issuing applicant on the specific issues that need to be explained in the batch issuing process. The verification can be carried out by means of telephone communication, written notice, etc. If necessary, on-site verification can be carried out. If it is necessary for the applicant to provide explanations or supplementary materials, it shall notify the applicant in writing and specify the time limit for reply.
If the batch issuing authority needs to further check the authenticity of the batch issuing application materials and samples, it shall timely send personnel to the production enterprise for on-site verification, take measures such as on-site access to original records, on-site inspection of equipment and logs, and conduct on-site sampling inspection as the case may be. The on-site verification shall be carried out in accordance with the relevant requirements of the on-site verification of the issuance of biological products, and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall be notified to send regulatory law enforcement personnel to assist.
Article 25 Under any of the following circumstances, the issuing and approving agency shall notify the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the issuing and approving applicant is located and where the production site is located, put forward suggestions for on-site inspection, and make a copy to the SDA:
（1） The sterility test is unqualified;
（2） Two consecutive batches of effectiveness indicators such as effectiveness fail to pass the inspection;
（3） Data review indicates that there may be serious problems in product production quality control, or production process deviation, quality difference, faults and accidents in the production process need further verification;
（4） The authenticity of the application materials or samples for approval and issuance may be questionable;
（5） Other situations indicating that the product has significant quality risks.
During the investigation and handling of the above problems, the acceptance or issuance of the corresponding varieties of the batch issuance applicant may be suspended.
If the above situations are found in the batch issuance of imported biological products, the batch issuance authority shall report to the SDA and put forward relevant suggestions such as on-site inspection.
Article 26 The drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall conduct an on-site inspection within 10 days after receiving the notification from the approval and issuance authority and the on-site inspection suggestions.
Within 10 days after the inspection, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize a technical assessment of the quality risk of the relevant batch of products proposed by the batch issuing authority and make a clear conclusion; Under special circumstances, the time limit may be extended appropriately and reasons shall be given. After receiving the notification on imported products and on-site inspection suggestions from the approval and issuing authority, the SDA shall organize the inspection center to conduct on-site inspection abroad in a timely manner according to the risk assessment. The time limit for overseas on-site inspection shall be determined according to the specific situation.
The inspection institution shall, according to the degree and scope of risks found in the inspection, put forward risk control suggestions for those that may need to take emergency measures. After receiving the notification, the drug regulatory department shall notify the approval issuing authority not to approve or suspend the approval issuing of the relevant products or all products of the approval issuing applicant, and order the approval issuing applicant to rectify.
After finding out the cause of the problem and completing the rectification, the applicant for approval and issuance shall report to the drug regulatory department and the approval and issuance authority. The drug regulatory department can resume the issuance of approval only after it has confirmed that it meets the requirements and notified the issuing authority.
Article 27 If the pharmaceutical supervisory and administrative department finds that there are major quality risks in biological products during the supervision and inspection, it shall, according to the inspection results, promptly notify the approval and issuance authority not to approve or suspend the approval and issuance of the relevant products of the drug marketing license holder.
Article 28 Where an applicant for issuance of an approval applies to withdraw the issuance of an approval, he/she shall state the reasons and may withdraw the approval only with the consent of the issuance authority; The applicant for approval of issuance shall report the withdrawal of the application for approval of issuance to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located. If the batch issuing authority has confirmed that the data review indicates defects and the inspection results do not conform to the provisions, the batch issuing applicant shall not withdraw.
If it is necessary to apply for withdrawal of the batch issuance due to the non conformance of the inspection results to the provisions in the process of synchronous batch issuance, the reasons shall be stated, and it can be withdrawn with the consent of the batch issuance authority.
Article 29 The batch issuing authority shall draw a conclusion on the batch issuing according to the results of data review, sample inspection or on-site inspection. If the requirements are met, a certificate of issuing a batch of biological products shall be issued, affixed with the special seal for issuing a batch, and issued to the applicant for issuing a batch.
The electronic certificate of batch issuance issued by the batch issuance authority has the same legal effect as the printed certificate of batch issuance.
When selling the biological products that are managed according to the batch issuance, a copy or electronic document of the batch issuance certificate of the biological products with the seal of the enterprise shall be issued.
Article 30 Under any of the following circumstances, a notice of disapproval of the issuance of biological products shall be issued to the applicant for approval of the issuance of biological products, and a copy shall be sent to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant for approval of the issuance of biological products is located or where the port of import is located:
（1） The data review does not meet the requirements;
（2） The sample fails to pass the inspection;
（3） The authenticity problem is found during on-site verification;
（4） In the on-site inspection, it is found that the drug production quality management specifications are violated and there are serious defects;
（5） Systematic and major quality risks of products are found during on-site inspection;
（6） The applicant for approval of issuance fails to supplement and correct the materials within the prescribed time limit without justified reasons;
（7） There are major quality risks through comprehensive assessment;
（8） Other items that do not meet the requirements of laws and regulations.
Article 31 The pharmaceutical supervisory and administrative department of the province, autonomous region or municipality directly under the Central Government where it is located shall supervise the destruction of the biological products that have not been approved or withdrawn from being approved and issued in accordance with the relevant provisions. Imported biological products that are not approved or whose approval and issuance are withdrawn shall be destroyed under the supervision of the drug regulatory department in the place where the port is located, or otherwise disposed of according to law.
Article 32 In the process of batch issuance, if it is found that the enterprise's products have quality problems or other potential safety hazards, involving batches that have already been listed and circulated, the batch issuance authority shall immediately notify the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the batch issuance applicant is located and where the production site is located; Those involving the import of biological products shall be notified to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the import port is located. Upon receiving the notification, the drug regulatory department shall immediately notify the applicant for approval and issuance.
The applicant for approval shall immediately take measures such as stopping the sale and use, recalling the defective products, etc., and destroy them under the supervision of the drug regulatory department in accordance with the relevant provisions. The batch issuing applicant shall submit the destruction records to the drug regulatory department and the corresponding batch issuing agency at the same time.
The drug regulatory department may, according to the risk assessment, take measures such as responsibility interview and rectification within a time limit.
Where an applicant for issuing a batch of products recalls products, it shall not be exempted from other legal liabilities that it should bear according to law.
Article 33 The approval issuing institution shall make an annual summary of the approval issuing work, which shall be reported to the SDA by the end of March of each year after being summarized and analyzed by the CIDI.

 

　　Chapter V Reexamination

Article 34 Where an applicant for issuing a batch of biological products disagrees with the notice of disapproval of issuance of biological products, he/she may, within 7 days from the date of receiving the notice of disapproval of issuance of biological products, file an application for reexamination with the original issuing authority or directly with the China National Inspection Institute.
Article 35 The original issuing authority or the Chinese People's Procuratorate shall make a decision on whether to review the application within 20 days from the date of receiving the application for review from the applicant for approval of issuance. The review content is limited to the original application items and the original materials submitted. If re inspection is required, the samples shall be those retained by the original issuing authority, and the time limit shall be in accordance with Article 22 of these Measures.
Under any of the following circumstances, the case shall not be reviewed:
（1） The unqualified items are sterile, pyrogen (bacterial endotoxin) and other items that are not allowed to be reinspected by the drug supervision and administration department;
（2） The sample is obviously uneven;
（3） The validity period of the sample cannot meet the inspection requirements;
（4） The applicant for approval and issuance promises in writing to give up reinspection;
（5） Failing to apply for reexamination within the prescribed time limit;
（6） Other cases that are not suitable for review.
Article 36 If the original decision is upheld in the reexamination, a notice of reexamination results for the issuance of biological products in batches shall be issued, and the reexamination application filed again by the applicant for issuance of biological products in batches shall not be accepted; If the review changes the original conclusion, the original notice of disapproval of issuance of biological products shall be withdrawn and a certificate of issuance of biological products shall be issued.

 
　　Chapter VI Information Disclosure

Article 37 The SDA shall establish a unified information platform for the batch issuance of biological products, publish the information such as the batch issuance organization, adjustment, and decision on handling major problems, provide the batch issuance applicant with the batch issuance progress and conclusion that can be queried, and timely publish the product information that has passed the batch issuance for public inquiry.
CIIC is responsible for the daily operation and maintenance of the biological product batch issuance information platform.
Article 38 An approval issuing institution shall publicize the approval issuing application procedures, the catalogue of approval issuing materials to be submitted, the model text of the application form, time limit requirements and other information on its website or the place where the application is accepted.
Article 39 Where the batch issuance has been approved, the batch issuance authority shall disclose the product name, batch number, enterprise, validity period, batch issuance certificate number and other information within 7 days.

 

　　Chapter VII Legal Liabilities

Article 40 If any of the following circumstances occurs to the drug regulatory department, the approval and issuance institution, the verification center and its staff in the approval and issuance work, the directly responsible person in charge and other directly responsible persons shall be punished according to law; If a crime is constituted, criminal responsibility shall be investigated according to law:
（1） Making a conclusion of approving the issuance of an application that does not meet the statutory requirements or making a conclusion of approving the issuance of an application beyond the statutory authority;
（2） The application meeting the statutory requirements is not approved for issuance;
（3） Violating the procedure requirements during the batch issuance process, disclosing the relevant work information to the batch issuance applicant or a third party without permission, causing serious consequences;
（4） Accepting or demanding the property of the applicant for approval of issuance or seeking other benefits in the process of approval of issuance;
（5） Failing to conduct on-site inspection as required.
Article 41 Where a batch issuing institution issues false inspection reports when undertaking the work related to batch issuing, it shall be punished in accordance with Article 138 of the Drug Administration Law.
Article 42 Where an applicant for issuing a batch of biological products provides false materials or samples, or intentionally conceals the major changes that affect the quality of the products, so as to defraud the certificate of issuing a batch of biological products, he shall be punished in accordance with the provisions of Article 123 of the Drug Administration Law.
Those who provide false data, materials, samples or commit other deceptive acts in applying for approval and issuance of vaccines shall be punished in accordance with Article 81 of the Vaccine Administration Law.
Whoever forges the certificate of approval and issuance of biological products shall be punished in accordance with Article 122 of the Drug Administration Law.
Article 43 Anyone who sells or uses biological products without obtaining the certificate of approval and issuance of biological products shall be punished in accordance with the provisions of Article 124 of the Drug Administration Law.

 

　　Chapter VIII Supplementary Provisions

Article 44 The time limit stipulated in these Measures shall be calculated by working days, excluding statutory holidays.
Article 45 The import of biological products under the administration of batch issuance shall also comply with the provisions of relevant laws and regulations on drug import. For biological products that are issued in batches as required by the SDA, the certificate of issuance of biological products in batches can be used as the customs clearance certificate of product qualification.
The exported vaccine shall meet the standards or contract requirements of the importing country (region), and can be applied for approval and issuance according to the standards or contract requirements of the importing country (region).
Article 46 The SDA shall be responsible for promulgating and updating the special seal for batch issuing institutions. The special seal for batch issuing of biological products is named "Special Seal for National Batch Issuing Institutions (X)". Where, X represents the abbreviation of the issuing authority.
The formats of the application form for issuing biological products in batches, the registration form for issuing biological products in batches, the certificate of issuing biological products in batches, the notice of not issuing biological products in batches, the application form for reexamination of issuing biological products in batches, and the notice of reexamination results of issuing biological products in batches shall be uniformly formulated and published by the Chinese Academy of Inspection.
The certificate of issuance of biological products in batches, the notice of non issuance of biological products in batches, and the notice of reexamination results of issuance of biological products in batches shall be uniformly affixed with the special seal for issuance of biological products in batches.
Article 47 The certificate of issuance of biological products in batches, the notice of disapproval of issuance of biological products, and the notice of reexamination results of issuance of biological products in batches shall be numbered by the issuing agency in the order specified by the SDA, in the format of "endorsement X (incoming) inspection XXXXXXXX", where the first X symbol represents the abbreviation of the administrative region or institution of the province, autonomous region, or municipality directly under the Central Government where the issuing agency is located, Import biological products use the word "import"; The first four digits of the last eight X symbols are the year of the A.D., and the last four digits are the sequence numbers within the year.
Article 48 These Measures shall come into force as of March 1, 2021. On December 29, 2017, the Measures for the Administration of the Approval and Issuance of Biological Products promulgated by the former Order No. 39 of the State Food and Drug Administration shall be repealed at the same time.