FDA生物制品审评中心生物制品上市申请【BLA、PLA、ELA及NDA】电子提交指南

潇湘子

Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format -Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Applications (NDA)]


I. INTRODUCTION............................................................................. 1
II. GENERAL ISSUES .......................................................................... 1
A. Refuse to File ........................................................................... 1
B. Review and Archival Copies........................................................ 2
C. Supplements and Amendments...................................................... 2
D. Electronic Signatures.................................................................. 2
III. ORGANIZING THE MAIN FOLDER................................................. 3
A. Submission Structure.................................................................. 3
B. Folders.................................................................................... 6
C. Cover Letter............................................................................. 7
D. Form FDA 356h ....................................................................... 7
E. BLA Table of Contents............................................................... 7
F. Figure of Main Folder ................................................................ 8
G. Submission Management ............................................................. 8
IV. ORGANIZING THE ELECTRONIC SUBMISSION ............................. 9
A. Item 1: Table of Contents (Index)................................................. 9
B. Item 2: Labeling......................................................................11
C. Item 3: Summary.....................................................................15
D. Item 4: Chemistry, Manufacturing and Controls (CMC) ...................16
E. Item 5: Nonclinical Pharmacology and Toxicology..........................21
F. Item 6: Human Pharmacology and Bioavailability/Bioequivalence .......28
G. Item 7: Clinical Microbiology.....................................................32
H. Item 8: Clinical .......................................................................32
I. Item 9: Safety Update...............................................................36
J. Item 10: Statistical ...................................................................36
K. Item 11: Case Report Tabulations (CRTs) .....................................36
L. Item 12: Case Report Forms ......................................................42
M. Item 13: Patent Information........................................................45
N. Item 14: Patent Certification.......................................................45
O. Item 15: Establishment Description ..............................................46
P. Item 16: Debarment Certification ................................................49
Q. Item 18: User Fee Cover Sheet...................................................49
R. Item 19: Other ........................................................................50
V. APPENDIXES.................................................................................51
Appendix 1: Example Nonclinical Pharmacology and Toxicology Datasets and
Data Elements..........................................................................51
Appendix 2: Example Content of specific clinical datasets ...........................61

潇湘子

生物制品是国家十二五计划重点发展领域，目前很多公司都上马了疫苗、单抗等大品种，并且取得了相当成绩，将该指南共享出来，希望对做生物制品的同行有所借鉴、有所参考。

andyouandme

谢谢

youngzhou

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言若

谢谢 !!!!!!!!!

shixiongjie

谢谢分享！！！！！！！！

gyxleo

好东西，谢楼主分享。

sccd

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GQL3709

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总统特使

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情非得已

谢谢分享！！！！！！！！！！！！！！

潇湘子

总统特使 发表于 2013-2-16 09:59
谢谢分享  学习学习

希望对大家有帮助！

goofy

下载看看，谢谢

Luckyjiajia

学习学习，谢谢楼主分享

houmeina

谢谢，你所提供的信息，我正在学习生物制品方面的知识，非常有帮助。

星辰大海vqx

有具体的文件类别和格式吗？