[医药]仿制化学药品研究技术指导原则意见稿.doc

【 】 指导原则编号: 化学药仿制药研究 技术指导原则 二OO七年 月 目 录如果标准中未规定杂质限度，产品的杂质含量明显高于已上市的同品种的杂质实测值1. FDA Guidance for industry ANDAs: impurities in drug substances, Nov. 1999 2. FDA Guidance for industry Court decisions, ANDAs approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the federal food, drug, and cosmetic act. Mar. 2000 3. FDA Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day. July 2003 4. FDA Guidance for industry Listed drugs, 30-month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare prescription drug, improvement, and modernization act of 2003, Questions and answers Oct. 2004 (Draft guidance) 5. FDA Guidance for industry bioavailability and bioequivalence studies for orally administered drug products-general considerations, March 2003. 6. FDA Guidance for industry extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlation, Sep 1997. 7. FDA Guidance for industry Topical dermatological drug product NDAs and ANDAs -in vivo bioavailability and bioequivalence, in vitro release, and associated studies, June 1998. (Draft guidance) 8. EMEA Notes for guidance on the investigation of bioavailability and bioequivalence. July 2001. 9. MALAYSIA The conduct of bioavailability and bioequivalence studies. Sep 2000. 10. MHW Guideline for bioequivalence studies of generics products, Dec 1997. 11. Roger L. Williams, Md et al, Equivalence approaches, Clin Pharmacol Ther 2002; 72:229-37 已有国家标准化学药品研究技术指导原则起草说明 （一）背景资料 1、“仿制药”这一概念是我国曾经使用的“仿制药”概念的延伸和扩展。《药品注册管理办法》（试行）相对于以前的《新药审批办法》缩小了新药定义范围，相应的扩大了“仿制药”的定义范围。我国于1999年颁布的《仿制药审批办法》中规定“仿制药系指仿制国家已批准正式生产、并收载于国家药品标准（包括《中国生物制品规程》）的品种。2002年颁布的《药品注册管理办法》（试行）中规定“仿制药的申请，是指生产国家药品监督管理局已经颁布正式标准的药品的注册申请”，同时规定国家药品标准包括国家药品监督管理局颁布的《中华人民共和国药典》、药品注册标准和其他药品标准。 由于“仿制药”定义的扩展，其研究的思路、方法与原“仿制药”有所不同。本指导原则是在对原“仿制药”研究的一般技术要求进行总结、分析的基础上，针对目前国内“仿制药”研究和评价中遇到的具体问题，通过系统的整理和分析而形成的对于“仿制药