摘 要
非专利药在世界医药市场上占据着举足轻重的作用，其注册文件和审批程序 越发引起业内人士的关注。本文通过对非专利药国内外注册申报历史数据、注册 审批程序、批准数量历史数据、批准时间历史数据、人力资源、注册文件的对比 分析，发现国内无论是在注册申报资料要求还是审批方面都存在一定的不足。为 此，笔者认为借鉴国外经过多年证实行之有效的 DMF 机制将有利于改善目前非 专利药注册体制存在的种种问题，并对基于 DMF 机制的审评给予适当的建议， 从而进一步完善非专利药注册审批机制，提高审批效率，使得非专利药在产品的 安全性、有效性和质量可控性上得到更好的保证。
关键词：非专利药（仿制药）、药品注册、审批、DMF、CTD
Discussion and Policy Analysis on Regulatory Submission for Generics at Home and Abroad
Abstract
Generic drugs play a very important role in global pharmaceutical market. Therefore, generic drug regulatory submission, review and approval procedures are of great interests to the industry. Through comparing and analyzing the regulatory information of generic drugs from China and abroad, with respect to the historical data of regulatory submission, review and approval procedure, historical data of approval number and approval time, human resource, and regulatory dossier, the author found that deficiencies exist in China in both the requirements of regulatory dossier as well as the review and approval procedures and processes. The author believes that the DMF system, which has been used by other countries and approved to be effective, will be beneficial to address problems generated from China’s current regulatory system for generic drugs. The author also attempts to provide constructive suggestions for DMF based review and approval systems. The goal is to further improve the regulatory review and approval system for generic drugs, to increase the review efficiency, and assure the quality, safety and efficacy of generic drugs.
Keywords: Generics
Pharmaceutical regulatory submission DMF CTD.
Review and approval 目 录
第 1 章 序言. ........................................................ 1 第 2 章 背景介绍. .................................................... 3
2.1 药品注册的定义 ................................................................................... 3 2.2 药品注册的发展史 ............................................................................... 3
2.2.1 欧美药品注册的发展史 ............................................................... 3 2.2.2 中国药品注册的发展史 ............................................................... 5 2.2.3 药品注册的发展史的启示 ........................................................... 7 2.3 DMF的定义及其发展 ........................................................................... 7
2.3.1 美国DMF ................................................................................... 7 2.3.2 通用技术文件（简称CTD） ....................................................... 8 2.4 非专利药 ............................................................................................ 10
2.4.1 非专利药在美国的定义 ............................................................. 10 2.4.2 非专利药在中国的定义 ............................................................. 10 2.4.3 非专利药和仿制药概念的异同 .................................................. 12
第 3 章 非专利药国内外注册申报审批状况比较分析. ..................... 13
3.1 非专利药在国内外申报历史数据分析 ................................................. 13
3.1.1 近几年国内新药和已有国家标准药品的申报统计数据 ............... 13 3.1.2 近几年美国非专利药申报的统计数据 ........................................ 14 3.1.3 中美非专利药申报统计数据对比分析 ........................................ 15 3.2 非专利药在国内外注册审批程序对比分析 .......................................... 16
3.2.1 中国SFDA非专利药审批程序 .................................................. 16 3.2.2 非专利药美国FDA审批程序 .................................................... 23 3.2.3 审批程序分析 ........................................................................... 25 3.3 非专利药国内外批准历史数据对比分析 ............................................. 25
3.3.1 中国SFDA批准数量历史数据 .................................................. 25 3.3.2 美国FDA批准数量历史数据 .................................................... 26 3.3.3 中国SFDA批准时间历史数据 .................................................. 27 3.3.4 美国FDA批准时间历史数据 .................................................... 28
3.3.5 审批历史数据分析 .................................................................... 28