制药研发趋势及中美仿制药申报注册要求对比课件.ppt

SFDA Review/Approval Process Chen Xiaoyuan, CDE, SFDA, 2008 * SFDA/CDE Workload Dong Lu and Wenlong Huang, Overview of drug evaluation system in China, 2010 * New Drug Application: FDA vs. SFDA * Dale Chenoweth , DDT. Volume 10, Number 17, September 2005 SFDA Progress: Review Timeline Application Type Timeline (Day) New Drug Clinical Trial 90 New Drug Manufacture 150 Change of Formulation 160 Generic Drug 160 Supplement 40 Import Re-registration 80 * 美国FDA与中国药监局 US FDA History: 100 year Budget: $3.2 billion (2010) Employees: as of Oct. 1, 2009 CBER 946 CDER 2,889 Total 11,516 Application approvals: IND: 2577 (2009) investigational, treatment, exploratory NDA: 131 505(b)(1); 505(b)(2) ANDA: 599 505(j) Chinese SFDA History: 8 years (SDA) Budget: RMB 707M (2010) Employees: as of Dec. 31, 2009 CDE 120 Total 47,472 Application approvals: New Drugs: CTA: 298; NDA: 164 Generic Drug: CTA: 196; ANDA: 1623 Import Drug: CTA: 320; NDA: 489 Supplement: SFDA: 2492; PFDA: 8537 * 相关指导原则 US FDA Advertising 3 (6 draft) Chemistry 31 (draft 12) Clinical Medical 47 (draft 29) Clinical Pharmacology 8 (draft 4) Combination Products 1 (drat 2) Current GMP/Compliance 29 (draft 12) Drug Safety 2 (draft 2) Electronic Submissions 7 (draft 7) Generic Drug 17 (draft 3) Good Review Practices 3 Pharmacology/Toxicology 14 (draft 6) ICH – Efficacy 22 (6) ICH - Joint Safety/Efficacy 10 (2) ICH - Quality 33 (9) ICH - Safety 15 (3) Chinese SFDA Chemical drugs: 32 TCM/Natural drugs: 14 Biologics: 26 Scientific review writing: 6 Review principles 6 Technical standards 13 US FDA Guidance Translation: CMC: 12 clinical pharmacology: 15 Clinical: 64 GRP: 2 Procedure: 3 * 阳性药选择 FDA对于仿制药所使用的参比制剂都有着硬性的规定。 FDA 在其处方药及非处方药的目录中都规定了参比的药品产品。以此来避免由于参比制剂使用的不同而可能导致的各仿制品之间发生显著的差异。 SFDA申请注册分类6的药品，应根据品种的工艺、处方进行全面的质量研究，按国家标准与已上市产品进行质量对比研究。无法按照国家标准与已上市产品进行质量对比研究的，应按照新药的要求进行质量研究，必要时对国家药品标准项目进行增订和/或修订。 * ? ? BIOSIMILARS Patient?Protection?and?Affordable?Care?Act? (PPACA) of?2010?c