摘要
目的探索美国药品审评创仿平衡机制。方法通过查阅美国法律法规及国内外文献,追溯仿制药发展的基础和原研药企业阻止仿制药竞争的行动,并由此归纳美国为维持药品审评创仿平衡稳定性采取的调整措施。结果与结论《药品价格竞争与专利期补偿法》中的简略新药申请、专利挑战制度以及首仿药市场独占制度构成仿制药发展的基础。原研药企业则通过提前抢占市场、拒绝提供研究用样品、提交公民请愿书延长仿制药审评时间及延长原研药专利期和市场独占期阻止仿制药竞争。美国通过立法、修订法律法规、调整仿制药企业收费政策等方式维持创仿平衡的稳定性,值得我国深入学习和研究。
OBJECTIVE To figure out the balance mechanism between brand-name drugs and generic drugs in American drug review. METHODS This paper reviewed FDA laws and regulations, domestic and foreign literature to retrospect the basis of generic development and explore the brand-name drug companies' action to prevent generic competition. RESULTS AND CONCLUSION The abbreviate new drug application, patent challenge and market exclusivity in the Hatch-Waxman Act were the basis of generic development. Brand-name drug companies prevented competition by occupying the market, refusing to provide samples, submitting citizen petitions to extend generic drug review time and extending the patent term and market exclusivity of brand-name drugs. The United States legislated and amended relevant laws and regulations, adjusted the generic drug user fee to maintain the stability of the balance, which is worthy of further research.
作者
冯霄婵
杨悦
FENG Xiao-chan;YANG Oue(Business Administration School , Shenyang Pharmaceutical University, Shenyang 110016, China;International Food and Drug Policy and law Center, Shenyang 110016, China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2018年第11期938-944,共7页
Chinese Pharmaceutical Journal
基金
国家食品药品监督管理总局课题项目资助(20170011)
工业和信息化部产业发展促进中心课题项目资助(2017021)
关键词
创仿平衡
药品价格竞争与专利期补偿法
专利挑战制度
balance mechanism between brand-name drug and generic drug
Hatch-Waxman Act.
patent challenge