美国FDA 指导原则 未经批准的非处方药上市后不良事件报告 英文原版.pdfVIP

Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2009 OTC OMB Control Number 0910-0636 Expiration Date: 06/30/2012 See additional PRA statement in Section VI of this guidance Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Additional copies are available from : Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2009 OTC Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 4 II. BACKGROUND 4 III. MINIMUM DATA ELEMENTS FOR AN INDIVIDUAL CASE SAFETY REPORT (ICSR) 6 A. Initial ICSR Submission 6 1. Identifiable Patient 7 2. Identifiable Reporter 8