Provisions for Lot Release of Biological Products
Chapter 1 General Provisions
Article 1 The Provisions are formulated with a view of strengthening quality control for biological products and ensuring the safety and effectiveness of biological products and in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law) and Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.

Article 2 Lot release of biological products (hereinafter referred to as “lot release”) is a system by which the State implements mandatory testing and examination for each lot of vaccine products, blood products, in vitro diagnostic reagents for blood donor screening and other biological products specified by the State Food and Drug Administration at the time of either leaving the factory for marketing or importation. Any product that fails to pass the testing or the examination shall not be marketed or imported.

Article 3 The State Food and Drug Administration is in charge of lot release of biological products nationwide. Drug testing institutes undertaking lot release testing or examination of biological products shall be designated by the State Food and Drug Administration.

Article 4 Standards for lot release testing or examination of biological products shall be the current national requirements for biological products or other drug specifications approved by the State Food and Drug Administration.

Chapter 2 Application
Article 5 After production and testing of a biological product subject to lot release, the drug manufacturer shall fill in an Application Form for Lot Release of Biological Products to apply for lot release to the drug testing institute undertaking lot release testing or examination.

Article 6 A biological product for lot release application must possess one of the following supporting documents for approval of drugs.
(1) Drug approval number;
(2) Import Drug License or Pharmaceutical Product License;
(3) Certificate of registration of biological in vitro diagnostic reagents

Article 7 Technical requirements for application of lot release and formats of relevant documents shall be formulated by the National Institute for the Control of Pharmaceutical and Biological Products, and submitted to the State Food and Drug Administration for approval and promulgation.

Article 8 The following materials and samples shall be submitted at the time of applying for lot release.
(1) Application form for lot release of biological products;
(2) Summary protocol for lot production and testing signed by head of the quality assurance department of the drug manufacturer and affixed with the seal of the department;
(3) Samples of the same lot required for testing;
(4) Other documents relating to product quality;
(5)To import biological products for preventive vaccine use, proof documents for lot release issued by the drug regulatory authority of the country of production shall be submitted along with the corresponding Chinese translation.

Article 9 For a biological product subject to lot release, with a short shelf life and a long testing period, upon confirmation by the State Food and Drug Administration, the drug manufacturer may apply for lot release to the drug testing institute undertaking lot release testing or examination after the production is completed.

Article 10 At the time of importing a biological product subject to lot release, its application for lot release shall be handled in accordance with requirements of the Provisions for Drug Importation.

Article 11 After receiving an application for lot release of a biological product, the drug testing institute undertaking lot release testing or examination shall decide whether or not to accept the application within five days. Where the application is not accepted, application shall be rejected and reasons thereof shall be explained.
Where the application dossier is incomplete or not in compliance with the defined format, the drug testing institute undertaking lot release testing or examination shall give an one-off notice to the applicant of all the contents needed to be added or corrected within five days. If a notice is not given within the time limit, the application shall be deemed as accepted from the day when the application dossier is received.
Where there is an error in the dossier that can be corrected on the spot, the applicant shall be allowed to make due correction.

Chapter 3 Testing, Examination and Release
Article 12 The drug testing institute undertaking lot release testing or examination shall be equipped with personnel and equipment suitable for the work of lot release testing or examination and in compliance with the quality assurance system and technical requirements for testing or examination of biological products.

Article 13 Either document review or document review with sample testing can be adopted for lot release testing or examination. Sample testing is divided into full testing and part item testing. Type of lot release testing or examination and testing items for specific product shall be determined after assessment by the National Institute for the Control of Pharmaceutical and Biological Products, reported to the State Food and Drug Administration for approval and announcement.

Article 14 The drug testing institute undertaking lot release testing or examination is responsible for reviewing application dossier. The review covers:
(1) Whether the application dossier is complete; whether summary protocol for lot production and testing of the product is affixed with the seal of the quality assurance department and signed by the head of the department;
(2) Whether the bacterial or viral seeds and cells used in production are consistent with those approved by the State Food and Drug Administration;
(3) Whether the production process is consistent with that approved by the State Food and Drug Administration; whether in-process quality control meets the requirements of the national drug standards;
(4) Whether testing items, methods and results of bulk liquid, bulk product and finished product meet the requirements of the national drug standard;
(5) Whether the package, label and insert sheet of the product comply with relevant regulations.

Article 15 The drug testing institute undertaking lot release testing or examination may increase testing items according to the need for examination of a specific product. The case and reason for increase of testing items shall be reported to the State Food and Drug Administration for the record.

Article 16 The drug testing institute undertaking lot release testing or examination shall complete lot release testing or examination within the time limit specified by the Provisions.
The State Food and Drug Administration shall make a decision on lot release according to the result of lot release testing or examination and issue a certification document for lot release to the applying drug manufacturer.

Article 17 Requirements for the time limit of lot release testing or examination:
After accepting an application for lot release, the drug testing institute undertaking lot release testing or examination shall complete its testing or examination within 55 days for vaccines, 30 days for blood products and 15 days for reagents for blood donor screening. The time limit for testing or examination of any other product shall be decided according to the length of testing period of the product.

Article 18 Where the drug testing institute undertaking lot release testing or examination cannot come to a conclusion concerning lot release testing or examination within the specified time limit, it shall notify the applicant in writing of the reason for extension and the time extended，and report the case to the State Food and Drug Administration for the record.

Article 19 Where the drug testing institute undertaking lot release testing or examination needs to verify relevant data in the application dossier, it shall give an one-off written notice to the applicant of all the data to be verified. The time limit does not include the period from the date the written notice is sent to the date the applicant replies to the drug testing institute undertaking lot release testing or examination with the verification result and its original record.

Article 20 The drug testing institute undertaking lot release testing or examination shall send its staff to the applying enterprise to carry out on-site inspection or sampling according to the need for document review.

Article 21 Issuance of certification document for lot release of biological products shall be completed within five days. Where requirements are met, a Certificate of Lot Release of Biological Products shall be issued.

Article 22 In any of the following circumstances, a Notice of Failure in Lot Release of Biological Products shall be issued and the unqualified items shall be indicated. The Notice of Failure in Lot Release of Biological Products shall be sent to the applicant for lot release. Meanwhile, a copy shall be sent to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.
(1) Application dossier is found in noncompliance with the requirements after examination;
(2) The product fails the quality test;
(3) The applicant’s reply concerning relevant data needed to be verified fails to meet the requirements.

Article 23 The Certificate of Lot Release of Biological Products and Notice of Failure in Lot Release of Biological Products shall be numbered in sequence by the drug testing institute undertaking lot release testing or examination. The format is “Pi Qian × (Jin) Jian××××××××”. The first “×” is the abbreviation of the name of the provincial administrative region of the place where the drug testing institute undertaking lot release testing or examination is located, or the abbreviation of the organization; the first four of the following eight “×”s represents the Christian year, the last four represents the serial number of the year.

Chapter 4 Second Review
Article 24 Where a drug manufacturer has any disagreement on the Notice of Failure in Lot Release of Biological Products, within seven days after receiving the Notice, it can file a second review application to the original drug testing institute undertaking lot release testing or examination or the National Institute for the Control of Pharmaceutical and Biological Products.

Article 25 The drug testing institute undertaking lot release testing or examination or the National Institute for the Control of Pharmaceutical and Biological Products shall make a decision on second review within 20 days from the date of receiving a second review application from a drug manufacturer. Second review is only limited to the original application matters and original documents submitted. Where verification testing is required, the samples to be used shall be those retained by the original drug testing institute undertaking lot release testing or examination, and the time limit shall be set as prescribed in requirements of Article 17 of the Provisions. Second review opinions shall be sent to the applicant for second review within five days after completion of the second review.

Article 26 Where the original decision is maintained after the second review, any application for further review filed by the applicant shall no longer be accepted; where the original decision is changed after the second review, the Certificate of Lot Release of Biological Products shall be issued. The original Notice of Failure in Lot Release of Biological Products shall be annulled simultaneously.

Chapter 5 Supervision and Penalties
Article 27 A duplicate of the Certificate of Lot Release of Biological Products affixed with the seal of the applicant shall be provided when selling a biological product subject to lot release.

Article 28 A biological product that fails lot release shall be destroyed by the drug manufacturer in accordance with relevant regulations. The record of destruction shall be, at the same time, submitted to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government and the drug testing institute undertaking lot release testing or examination for the record.

Article 29 A drug manufacturer who provides false information or samples shall be punished in accordance with the provisions in Article 83 of the Drug Administration Law.

Article 30 A drug manufacturer who sells a biological product without a Certificate of Lot Release of Biological Products shall be punished in accordance with the provisions in Article 48 and Article 74 of the Drug Administration Law.

Article 31 A drug manufacturer who forges a Certificate of Lot Release of Biological Products shall be punished in accordance with the provisions in Article 82 of the Drug Administration Law.

Article 32 A drug testing institute undertaking lot release testing or examination who provides false reports shall be punished in accordance with the provisions in Article 87 of the Drug Administration Law.

Article 33 In any of the circumstances prescribed in Article 30 and Article 31 of the Provisions, the drug manufacturer shall be ordered to take back its biological product already sold on the market. The product shall be destroyed under the supervision of the (food and) drug regulatory department in accordance with relevant regulations.

Chapter 6 Supplementary Provisions
Article 34 Summary protocol of lot production and testing for a biological product refers to critical points of operation and results that affect the quality of a biological product and correctness of the testing result of each lot of the biological product during the entire process of production from raw materials to packaging, and during the testing, which shall be examined by the quality assurance department of the applicant.

Article 35 For the need of public health, biological products subject to lot release, which are called into emergency use for controlling epidemics or unexpected incidents, and vaccines subject to lot release, which are donated by the United Nations International Children’s Emergency Fund or other international organizations, can be exempted from lot release upon approval of the State Food and Drug Administration.

Article 36 The State Food and Drug Administration is responsible for the interpretation of the Provisions.

Article 37 The Provisions shall go into effect as of the date of promulgation. The Provisions for Lot Release of Biological Products (Trial) promulgated by the State Food and Drug Administration as Decree No. 36 shall be annulled there from.