Release of Chinese management practices imported biological products
July 13, 2004 release
State Food and Drug Administration Order No. 11
"Release of Biological Products Management Measures" on June 4, 2004 by the State Food and Drug Administration Bureau of Finance Council, is hereby released. The management practices implemented from the date of publication.
July 13, 2004
Release of biological products, management practices
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 audit is not 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.
Fourth batch release testing of biological products, or the assessment criteria for the existing national Biological Products or approved by the 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, drug manufacturer shall fill out "Application Form for Release of Biological Products," Release of test or examination to take drug test to apply for lot release.
Article 6 When applying batch release of biological products must have one of the following drug approval documents:
(I) drug approval number;
(Ii) "Import Drug License" or "Pharmaceutical Product License";
(Iii) approving the registration of in vitro biological diagnostic reagents to prove.
Release of the Article VII application and related information technology requirements of the format, by the Chinese pharmaceutical and biological products is responsible for organizing 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) pharmaceutical manufacturers quality assurance department head signed and stamped with the seal of the department's summary of batch manufacturing and inspection records;
(C) the test samples required for 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 certificates issued, and 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 to undertake the audit institutions to apply for approval of drug testing issue.
Article in accordance with batch release of biological products have been imported, its application in accordance with Release of "drugs imported management practices" regulations.
Article XI Release of inspection or audit undertake drug testing agency received an application for batch release of biological products, 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 should be corrected to allow the applicant on the spot.
Chapter III Inspection, audit and issue
Release of Article XII of commitment to drug testing agency shall bear the lot release testing with its audit work or to adapt to the personnel and equipment, inspection or review of biological products meet the quality assurance system and technical requirements.
Article XIII of the batch release testing or audit separately take the form of data review, data review and can take a combination of test samples. Sample test is divided into all parts of the project inspection and project inspection.
Release of specific varieties used in ways test or review 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 review of drug testing institution responsible for reporting data review, 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, etc. 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 of compliance with the provisions of the national drug standards;
(E) product packaging, labels and instructions are in line with relevant regulations.
Article XV batch release testing, or take the drug testing institution audits based on review of 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 take the drug test or inspection agency shall review this work under way within the time batch release testing or audit.
State Food and Drug Administration inspection according to the batch release Release of audit findings or decisions to apply for lot release issued by drug manufacturers batch release documents.
Release of Article XVII time inspection or audit 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 of the batch release testing, or take the drug testing institution in the audit within the time limit can not make the batch release testing or audit conclusions, it shall 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 inspection or audit undertake drug testing agencies to apply information in the data need to check, it shall notify in writing a one-time batch release reporting companies. Since the date of the notice until a written declaration of the results of their original record company will check 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 on-site verification or 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" to send the batch release of the enterprise application, copied to 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 of 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 × ×××××××", Among them, × symbols bear batch release testing or review of the provincial drug inspection agencies or institutions referred to the administrative area; 8 × symbol after the first four year reign as the latter 4 sequence number during the year.
Chapter re-trial
Article 24 Drug manufacturers batch release of biological products failed notice of dissent, and 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 agency or Chinese medicines 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 provisions of Article 17 of the 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 and issue a "certificate of Release of Biological Products," the original "batch release of biological products failure notice" at the same time abolished.
Chapter supervision and punishment
Batch release in accordance with Article 27 of the biological products in the sales, you must provide stamped with the seal of the enterprise batch biological products, "batch release of biological products certificate" copy.
Release of Article 28 failed by the pharmaceutical manufacturers of biological products in accordance with relevant provisions of the destruction, the destruction of records should also submit the provinces, autonomous regions and municipalities (food) and Drug Administration and the batch release testing or examination 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 of 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, the listed sales of biological products, pharmaceutical manufacturers should be ordered to withdraw, 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 emergency and emergency use in accordance with batch release of biological products, as well as UNICEF or other international organizations, donations in accordance with 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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