ANDA以与仿制药业务.pptVIP

ANDA及仿制药业务 ANDA and generic business development;IND Investigational Dew Drug; NDA New Drug Application; ANDA Abbreviated New Drug Application ;IND;IND所需要的资料;NDA;;ANDA;Registration procedure;Organization of CDER;Registration File ;Registration File ;Registration File;Registration File;DMF introduction;DMF Submission;DMF COS(CEP);生产厂直接申请 ;International Conference on Harmonization of Technical Requirements ForRegistration of Pharmaceuticals for Human Use;Common Technical Document;;Product Life Cycle;Clinical 1;几个数字的背后：新药开发的艰难;;首仿;全球医药市场份额%，2008;医药市场发展速度%平均3-4%，2008;2008年全球仿制药市场;2001-2008年全球仿制药的市场增长;仿制药市场发展全球预测;从2006年期起全球制药企业与仿制药进入热恋期！“抗争不过，不如加入” ;Mergers and Acquisitions;Mergers and Acquisitions;;Global leaders in generic business;Competitors;Competitors;Competitors;Teva Pharmaceutical Industries Limited ;Dr. Reddys Laboratories Ltd. ;仿制药申请流程！;仿制药申请流程！;仿制药申请流程！;仿制药申请流程！;仿制药申请流程！;Difficulty scale;Distribution;US Distribution