国内制药企业申报FDA制剂仿制药的调查与分析

Investigation and Analysis of Domestic Pharmaceutical Firms to Obtain Approval of Preparation Abbreviated New Drug Application from FDA

目的为国内制药企业进行制剂仿制药FDA申报提供建议,促进我国制药企业的制剂国际化。方法通过对国内代表性的制药企业进行问卷和采访调查,并结合FDA仿制药申请的法规,分析影响国内制药企业申报美国制剂仿制药的主要因素。结果与结论提出促进我国制药企业申报FDA制剂仿制药的建议。

Objective To provide some suggestion to native pharmaceutical firms for pursuing approval of preparation ANDA from FDA,and promote the internationalization of preparation.Methods Through social survey of several native representative pharmaceutical firms,the general condition of native pharmaceutical firms in applying preparation ANDA was studied.Considering the ANDA regulations of FDA,the major constraints to our domestic firms pursuing approval of preparation ANDA from FDA were analyzed and discussed.Results and Conclusion Suggestion for native pharmaceutical firms to pursue approval of preparation ANDA was offered aim to promoting the internationalization of preparation.