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Laws & Regulations - Drugs - Provisions for Lot Release of Biological Products
Provisions for Lot Release of Biological Products
 
2012/3/20 14:24:14¡¡Source: ¡¡Hits:

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

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