美国仿制药申请中应注意的问题及对我国的启示

Consideration on Abbreviate New Drug Application in U.S.A. and Its Implication for China

目的为我国仿制药进入美国市场提供参考。方法通过文献分析和例证法等方法,阐述美国ANDA(Abbreviate New Drug Application,简略新药申请)审评中的审评程序、技术要求及常见缺陷。结果仿制药要进入美国市场,必须提交ANDA,ANDA申请人应按照相关的法律法规递交充分的科学论证,才能有助于加快审批流程。结论我国制药行业应抓住国际化的重要机遇,正确理解FDA先进科学的药品管理体系,同时完善我国仿制药注册审评制度,实现更多仿制药在美国等发达国家市场的上市。

OBJECTIVE To provide references for domestic genetics going into the US market. METHODS The literature analysis, illustration and other research methods were used in this study to study the aspects including the framework of legislation, review process of genetics,requirements on technical contents and common deficiencies during the ANDA （Abbreviate New Drug Application） review in the United States （US）. RESULTS A generic drug must submit the ANDA application to obtain approval before entering the US market, a ANDA applicant should submit sufficient and reliable demonstrations to accelerate the approval process. CONCLUSION The domestic pharmaceutical industry should seize the opportunity of internationalization, correctly understand the advanced and sound drug management system of FDA, as well as improve the generic approval system, to help more and more generic enter the US market.