中美仿制药研发申报流程资料解读.pptVIP

药物经济学催生美国仿制药制度 美国社会安全制度导致政府赤字严重 SSA已经破产：如何破局？ 降低医疗费用成为必然 Hatch-Waxman法案出台 美国FDA药品注册申请：新药（两类）、仿制药和非处方药申请 1984年后 NDA的研发和申报 505(b)(1) 新药申报资料内容 Index Summary Chemistry, Manufacturing and Control Samples, Methods Validation Package and Labeling Nonclinical Pharmacology and Toxicology 6. Human Pharmacokinetics and Bioavailability 7. Microbiology ( for anti-microbial drugs only) 8. Clinical Data 9. Safety Update report ( typically submitted 120 days after the NDA’s submission ) 10. Statistical 11. Case Report Tabulations 12. Case Report Forms 13. Patent Information 14. Patent Certificati