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从新药定义的“缩水”看我国政府对药品创新的扶持 被引量:2

Perspective of Government Support on Drug Innovation from Changes of New Drug Definition
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摘要 目的探讨我国政府对药品创新的扶持力度。方法从药监史上的三个新药定义入手分析新药的界定对药品创新的引导。结论我国对药品创新扶持力度正在逐步增加,所制定的"新度"标准也正在逐步提高,对新药的态度在由"保护主义"向"审查主义"过渡。 Objective To discuss government's support and protection of drug innovation. Methods Investigate from the three definitions in history. Conclusions The supporting to drug innovation is gradually increased, the standard is gradually improved.
作者 宋燕 邵蓉
出处 《中国医药技术经济与管理》 2008年第10期84-87,共4页 China Pharmaceutical Technology Economics & Management
关键词 药品管理 药品注册 新药 创新 drug administration drugs registration new drag innovation
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  • 2FDA. Subpart C:Meetings. Title 21 Part 314.47. Code of Federal Regulation USA, 1992
  • 3Office of the Law Revision Counsel. Sec.355: New drugs. Part A-Drugs and Devices. CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT. TITLE 21-FOOD AND DRUGS. United States Code, 2004,3

共引文献12

同被引文献18

  • 1王二丽,何荣和.中药材和中药饮片概念之浅见[J].海峡药学,2007,19(9):147-149. 被引量:10
  • 2夏金彪.《国际制药分工给中国药企走出去以新机遇》,《中国经济时报》2006年9月7日,第2版.
  • 3普华永道.《中国医药行业展望(第二版)》,2009年.
  • 4黄严忠.《中国制药业:全球健康的游戏规则改变者?》,美国外交关系协会,2015年.
  • 5陈正扬.《中国制药产业发展--双元分裂的未来或整合的前奏》,政治大学国家发展研究所硕士论文,2010年.
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  • 7Kale, D., & Little, S., "From Imitation to Innovation: The Evolution of R&D Capabilities and Learning Processes in the Indian Pharmaceutical Industry". Technology Analysis & Strategic Management, 19(5), 2007, PP.589 - 609.
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  • 10Singh, S. "Indian Pharma Enters the Global Arena", Ceil, 128 (5), 2007, PP.811-814.

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