"Release of Biological Products Regulations" (Board Order No. 11)
July 13, 2004 release

State Food and Drug Administration Order No. 11

"Release of Biological Products Regulations" on June 4, 2004 by the State Food and Drug Administration Bureau of Finance Council, is hereby released. The Regulations come into force from the date of publication.

July 13, 2004

Release of Biological Products Regulations

Chapter I General Provisions

In order to strengthen quality control of biological products, biological products to ensure safe and effective, according to the "Drug Administration Law of the People's Republic" (hereinafter referred to as the "Drug Administration Law") and "Implementation Regulations of the PRC Drug Administration Law," formulated.

The second batch release of biological products (hereinafter referred to as batch release), is the state of vaccine products, blood products, blood screening for in vitro biological diagnostic reagents, and the State Food and Drug Administration and other biological products, each batch of listing of the factory or imported products when the mandatory inspection, audit system. Failed inspection or review will not be approved, shall not be marketed or imported.

Third head of State Food and Drug Administration National Release of biological products work; bear batch release testing of biological products or audit of the drug testing institution by the State Food and Drug Administration designated.

The fourth batch release testing of biological products or review existing national standards for biological products or procedures approved by State Food and Drug Administration standards for other drugs.

Chapter II Application

Article by batch release of biological products in the production, inspection is completed, pharmaceutical manufacturers should fill out the "Application Form for Release of Biological Products," Release of test or examination to take drug test to apply for lot release.

Release of Article VI of the application of biological products must have the approval documents of the following drugs:
(I) drug approval number;
(Ii) "Import Drug License" or "Pharmaceutical Product License";
(Iii) approval of in vitro biological diagnostic reagents registration certificate.

Release of the Article VII application and related information technology requirements of the format, by the Chinese pharmaceutical and biological products responsible for the organization and submitted to the State Food and Drug Administration approval and release.

Article 8 The application should be submitted to the following Release of information and samples:
(A) Release of Biological Products Application Form;
(B) Drug manufacturers quality assurance department heads signed and stamped with the seal of the department's summary of batch manufacturing and inspection records;
(C) the test sample required the same batch;
(D) and other information related to product quality;
(E) the prevention of imported biological products like vaccines should be submitted simultaneously producing the national drug regulatory authority batch release certificate issued by, and to provide a Chinese translation.

Article IX for valid short and long test cycle in accordance with batch release of biological products, by the State Food and Drug Administration confirmed, drug manufacturers produced immediately after the completion of the batch release testing or review to take drug test to apply for grant issue.

Batch release in accordance with Article X of the import of biological products, its application in accordance with Release of "Drug Import Regulations," the regulations.

Article XI Release of inspection or audit undertake drug testing institution batch release of biological products received the application, shall, within five days to decide whether to accept. Inadmissible, the trial to be back, and the reasons.
Application materials are incomplete or do not meet the statutory form, bear the lot release testing or drug testing institution shall be audited within five days inform the applicant to make corrections once the entire contents, fails to do so, since the date of receipt of application materials is accepted.
Application materials can be corrected on the spot the error, it shall allow the applicant on the spot corrections.

Chapter III Inspection, audit and issue

Release of Article XII to bear with the drug testing agency shall bear the Release of its inspection or audit of personnel and equipment to adapt to meet biological products inspection or audit of the quality assurance system and technical requirements.

Article XIII of the batch release testing or audit data can be reviewed individually to take the form of information can also be taken to review and sample test combination. All test items are divided into test samples and test some of the projects.
Release of specific varieties used by way of inspection or audit and inspection of projects by the Chinese pharmaceutical and biological products determined to organize demonstration, the State Food and Drug Administration approval, and to the announcement.

Release of Article XIV bear examination or audit of the drug testing institution responsible for reporting data review, the audit include:
(A) declare whether the information is complete, the product batch manufacturing and inspection records summary is stamped seal of quality assurance department, whether official signature;
(B) the production of bacteria and viruses, cells, such as whether the State Food and Drug Administration approved the same;
(C) whether the production process and the State Food and Drug Administration approval process consistent; production process quality control whether the national drug standards;
(D) of liquid products, semi-finished and finished products inspection items, methods and results are in line with the provisions of the national drug standards;
(E) product packaging, labels and instructions are in line with relevant regulations.

Release of Article XV take drugs test or audit inspection agency can review the need to increase the specific varieties of test items. Increase the test project and the reasons shall be reported to the State Food and Drug Administration for the record.

Release of Article XVI bear examination or audit of the drug testing institution shall work in this way within the time specified batch release testing or audit.
State Food and Drug Administration, batch release test according to the batch release of audit findings or the decision to apply for lot release issued by drug manufacturers batch release documents.

Release of inspection or review Article XVII time requirements:
Release of test or take drugs audit batch release testing agency to receive an application, the vaccine products should be completed in 55 days; class products, blood products should be completed in 30 days; blood screening products, reagents should be completed within 15 days; Other products should be based on the product test cycle to determine the specific test or examination time.

Article 18 Release of inspection or audit undertake drug testing institution within the prescribed time limit or not to review the conclusions of the batch release testing should be extended in writing the reasons and time batch release reporting companies and report to the State Food and Drug Administration record.

Article 19 Release of test or take the drug testing agencies to review information in the application need to check the data, it shall notify in writing a one-time batch release reporting companies. Written notice from the date of issue until the results of their reporting companies will check the original records of the batch release testing or response take the drug testing agency review period ending not included in the time limit.

Release of inspection or audit Diershitiao take the drug testing institution shall, according to the needs of data review, sent to the reporting enterprise or site verification sampling.

Twenty-one documents batch release of biological products shall be issued within five days. Meet the requirements, the issue of "batch release of biological products certification."

Article 22 Where the following circumstances, the issue of "failure notice Release of Biological Products", and indicate the failed project. "Release of Biological Products unqualified notice" Release of the company to send applications, with a copy of the enterprise of the province, autonomous regions and municipalities (food) and Drug Administration:
(A) the disclosure of information by the review does not meet the requirements;
(B) the quality of the unqualified;
(C) the applicant need to check the data on the response data is still not meet the requirements.

Article 23 "certificate Release of Biological Products" and "Release of Biological Products unqualified notice" Release of inspection or audit by the commitment of the drug testing institution in accordance with the order number, the format of "endorsed × (into) check × ×××××××", which, before the × symbols represent the commitment to the batch release testing or review of the provincial drug inspection agencies or institutions referred to administrative region; after 8 × symbol as the first four year reign, after the 4 sequence number during the year.

Chapter re-trial

Article 24 Drug manufacturers batch release of biological products failed dissenting notice, from the receipt of 7 days from the date of notification, apply to take the batch release testing or drug testing institution or review of Chinese medicines and biological products application for review.

Article 25 Release of inspection or audit undertake drug testing institution or the Chinese pharmaceutical and biological products from the pharmaceutical manufacturer received the application for review within 20 days to review the decision, review is limited to matters of their original application submitted to the original information. Need to review the required test, and its commitment to the batch release of the original sample drug testing institution to retain the samples, the time limit in accordance with the provisions of Article 17 of these Measures. 5 days after completion of review to apply for a review of the company issued a review of opinions.

Article 26 review to maintain the original decision no longer accept the applicant's application for review again; review to change the original decision, the issue of a "biological product batch release certificate", the original "batch release of biological products failure notice" at the same time abolished. 

Chapter supervision and punishment

Article 27 in accordance with batch release of biological products in the sales, you must provide stamped with the seal of the enterprise batch of biological products, "batch release of biological products certificate" copy.

Article 28 failed lot release of biological products by the pharmaceutical manufacturers to be destroyed in accordance with relevant regulations, while the destruction of records should be submitted to the provinces, autonomous regions and municipalities (food) and the batch release and Drug Administration inspection or audit of drug testing for the record.

Article 29 pharmaceutical manufacturers to provide false information or samples, according to "Drug Administration Law," Article 83 shall be punished.

Article 30 sales without the "batch release of biological products certification" of biological products, in accordance with the "Drug Administration Law," Article 48 and Article 74 shall be punished.

第三十一条 forged "certificate Release of Biological Products", in accordance with the "Drug Administration Law," Article 82 shall be punished.

Release of Article 32 take the drug test or audit inspection agency issued a false inspection reports, in accordance with the "Drug Administration Law," Article 87 shall be punished.

Article 33 belongs to the Article 30, Article 31 cases, and biological products have been marketed, it shall order pharmaceutical manufacturers to recover, and in accordance with the relevant provisions in (food) drug regulatory department under the supervision shall be destroyed.

Chapter VI Supplementary Provisions

Article 34 approved biological products manufacturing and inspection records summary refers to the biological products from each batch of raw materials to packaging production process and testing of biological products that affect the quality and accuracy of the results of the operation points and results, by corporate quality assurance department review.

Article 35 The health needs for public health, to control the epidemic or unexpected events and emergency use in accordance with batch release of biological products, as well as UNICEF or other international organizations in accordance with donated batch release of vaccine products, by the State Food and Drug Administration approval, may be exempt from batch release.

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

Article 37 These Measures shall come into operation on the date of publication. State Drug Administration Order No. 36 "Release of Biological Products Regulations" (Trial Implementation) shall be repealed simultaneously.

Accessories Catalog:
Attachment:
1. "Release of Biological Products Application Form"
2. "Registration Form Release of Biological Products"
3. "Batch release of biological products certification."
4. "Release of Biological Products unqualified notice"

  

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