FDA指南ANDA原料药与制剂稳定性试验问答.doc

201405 FDA指南：ANDA：原料药和制剂稳定性试验问答 Guidance for Industry 行业指南 ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 Final GUIDANCE 终稿指南 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2014 Generics  Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 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) May 2014 Generics  TABLE OF CONTENTS 目录 I. INTRODUCTION介绍 II. QUESTIONS AND ANSWERS提问和回答 A. General一般问题 B. Drug Master File药物主文件. C. Drug Product Manufacturing and Packaging药品生产和包装 D. Amendments to Pending ANDA Application未批准ANDA申请的增补 E. Stability Studies稳定性试验.  Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 本指南代表的是FDA目前对这一专题的态度。它并未建立或赋予任何个人任何权利，并不与FDA或公众有任何绑定。你可以使用任何一种替代方法，只要所用的方法满足成文的法规要求。如果你想要讨论一个替代方法，请与FDA负责实施本指南的相关人员联系。如果你无法识别要联系的人，可以拨打本指南首页所列的相应的电话号。 I. INTRODUCTION介绍 This guidance provides answers to questio