美国FDA 指导原则 生物制品行业变更为批准应用的指南 英文原版.pdfVIP

Guidance for Industry Changes to an Approved Application: Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research July 1997 TABLE OF CONTENTS Note: Page numbering may vary for documents distributed electronically I. INTRODUCTION 01 II. CHANGES UNDER §601.12(b) 03 Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes). III. CHANGES UNDER §601.12(c) 05 Changes requiring supplement submission at least 30 days prior to distribution of the product made using the change. IV. CHANGES UNDER §601.12(d) 07 Changes to be described in an annual report (minor changes). V. COMPARABILITY PROTOCOLS UNDER §601.12(e) 09 VI. CHANGES UNDER §601.12(f) 09 Labeling changes. A. Changes under §601.12(f)(1) - Labeling changes requiring 10 supplement submission - FDA approval must be obtained before distribution of the product with the labeling change. B. Changes under §601.12(f)(2) - Labeling changes requiring 10 supplement submission -