FDA变更指南中英文.pdf

Guidance for Industry Changes to an Approved NDA or ANDA 已批准申请的新药变更指南 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2004 CMC Revision 1 I. INTRODUCTION AND BACKGROUND This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) who intend to make post approval changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) and § 314.70 (21 CFR 314.70). The guidance covers recommended reporting categories for postapproval changes for drugs other than specified biotechnology and specified synthetic biological products. It supersedes the guidance of the same title published November 1999. Recommendations are provided for postapproval changes in (1) components and composition, (2) manufacturing sites, (3) manufacturing process, (4) specifications, (5) container closure system, and (6) labeling, as well as (7) miscellaneous changes and (8) multiple related changes. 本指南给打算将已批准变更的新药上市申请和新药报审简表申请的持有者提供建议，使其按照联邦食 品、药品、化妆品法案的506A 部分和§ 314.70 (21 CFR 314.70)。该指南包括建议对药品除了其他指 定的生物技术和特定的合成生物制品的已批准变更进行报告类别。它取代了发表于 1999 年11 月同一 标题的指导原则。为以下已批准的变更提供建议（1）成分和组成 （2 ）厂址 （3 ）生产工艺 （4 ） 质量标准 （5 ）包装 （6 ）标签 （7 ）其它变更 （8 ）复杂相关变更 Recommendations on reporting categories for changes relating to specified biotechnology and specified synthetic biological products regulated by CDER are found in the guidance for industry 建议由药品评价和研究中心规定对有关指定生物技术和特定的合成生物制品的变更进行报告类别，出 现在企业的指南中 。 Paperwork Reduction Act Public Burden Statement: This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collection(s) of information in this guidance were approved under OMB Control No. 0910-0538 (until August 31, 2005). 文书工作减少法案：本指南包 含资料的收集贮藏受到管理和预算办公室（OMB ）的审查，根据1995 年的文书工