电子申报方式提交上市后产品安全报告的指南

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FDA ---采用电子申报方式提交上市后产品安全报告的指南（有需要的下载）
I. INTRODUCTION..............................................................................................................................................1
II. BACKGROUND ................................................................................................................................................3
III. GENERAL INFORMATION ABOUT ICSR SUBMISSION ...................................................................3
A. PARTS OF AN ICSR SUBMISSION......................................................................................................................4
B. OPTIONS FOR ELECTRONIC SUBMISSION OF ICSRS TO FDA ............................................................................4
C. TECHNICAL SPECIFICATIONS FOR ELECTRONIC SUBMISSION OF ICSRS ...........................................................5
D. UNIQUE CASE IDENTIFICATION NUMBERS FOR INITIAL AND FOLLOWUP ICSRS ..............................................5
E. SUBMITTING LABELING AND LABELS...............................................................................................................5
F. NOTIFICATION OF INITIAL ELECTRONIC ICSR SUBMISSION.............................................................................6
G. SENDING IN SUBMISSIONS................................................................................................................................6
H. NOTIFICATION OF RECEIPT OF SUBMISSIONS BY THE FDA...............................................................................7
1. Direct Submission Through the ESG..........................................................................................................7
2. Submission Through the SRP .....................................................................................................................7
I. CONTINGENCIES IF THE ESG, SRP, OR FAERS IS TEMPORARILY UNAVAILABLE............................................8
IV. POSTMARKETING SAFETY REPORTS OTHER THAN ICSRs .........................................................9
V. WAIVER REQUESTS.....................................................................................................................................10
A. CONTENT OF WAIVER REQUESTS...................................................................................................................10
B. WHERE TO SUBMIT WAIVER REQUESTS.........................................................................................................10
C. FDA RESPONSE TO WAIVER REQUESTS.........................................................................................................11
This is one in a series of guidance documents intended to assist applicants making certain 16 regulatory submissions in electronic format to the Center for Drug Evaluation and Research 17 (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug 18 Administration (FDA or the Agency). This draft guidance revises and replaces the draft 19 guidance for industry entitled Providing Regulatory Submissions in Electronic Format – 20 Postmarketing Individual Case Safety Reports, issued on June 12, 2008 (73 FR 33436). It 21 provides general information pertaining to electronic submission of postmarketing safety reports 22 (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments)2 and other 23 postmarketing safety reports) for the following products