文档介绍：中美仿制药研发和申报流程涂家生, Ph. D. 中国药科大学药剂学教授 Tel: 025-83271305 Email: jiashengtu@ 郑州我国仿制药申报、审评和研发对策我国仿制药申报、审评和研发对策主要内容主要内容中美关于原研药和仿制药的背景中美关于原研药和仿制药的背景美国仿制药:申报、基于问题的审评和研发对策美国仿制药:申报、基于问题的审评和研发对策展望展望 1 12 23 34 pany Logo 3 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 New Drug Applications (NDAs) Abbreviated New Drug Applications (ANDAs) ?“ Full Reports ” of Safety and Efficacy Investigations ? Applicant has right of reference to essential investigations? ? Duplicate of an already approved product ? No safety/efficacy data permitted (only bioequivalence) YES NO 505(b)(1) 505(b)(2) 505(j) NDA 的研发和申报 505(b)(1) 新药申报资料内容 1. Index 2. Summary 3. Chemistry, Manufacturing and Control 4. Samples, Methods Validation Package and Labeling 5. Nonclinical Pharmacology and Toxicology 6. Human ics 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 Certification 505(b)(2): 历史过程? Hatch Waxman 法案: 1984 ? Parkman Letter ? Phantom ANDA ? FDA Draft Guidance for Industry (1999) ? FDA Response to Citizen ’ s Petition ( 2003) ?可以降低研发的费用和审评力量的浪费 505(b )(2 )的关键:可靠性? What is “ Reliance ”? By whom? ? On what? ? Reliance and Exclusivity ? Market vs. Data Exclusivity ? Safety/Efficacy Data vs. CM&C data ? FDA Process for Determining Reliance ? Who, when and how?