国内制药企业申报FDA制剂仿制药的调查与分析.pdfVIP

8 2011 25 1 理论探讨 FDA 徐月红, 苏铌雅, 吴传斌( , 510006) : 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 通过对国内代表 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提出促进我国制药企业申报FDA 制剂仿制药的建议 : 制剂; FDA; 制药企业; ANDA : R9517 ( 712) : A : ( 2011) Investigation andAnalysis of Domestic Pharmaceutical Firms to Obtain Approval of Preparation Abbreviated NewDrug Application from FDA Xu Yuehong, u N iya and Wu Chuanbin ( chool of Pharmaceutical ciences, un Yatsen University, Guangzhou 510006) ABST ACT: ObjectiveT o 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 AN DA w as studied Considering the A NDA regulations of FDA, the major constraints to our domestic firms pursuing approval of preparation ANDA from FDA w ere analyzed and discussed esults and Conclusion uggestion for native pharmaceutical firms to pursue approval of preparation ANDA w as offered aim to promoting the internationalization of preparation KEYWO DS: preparation; FDA; pharmaceutical firms; ANDA [ 3] , FDA , FDA ANDA , AN DA ? [ 1] , , ANDA ? , ANDA , ( Abbreviated New Drug FDA ANDA Application; ANDA, ) , ANDA ANDA , , , ANDA , , [ 2] [ 4] ,