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: ******@
郑州
我国仿制药申报、审评和研发对策
主要内容
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
展望
1
2
3
4
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
3
Ceryak
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
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 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FDA Draft Guidance for Industry (1999)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?