Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org

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History 1998: GCP for trial implementation by MoH 1999: GCP by SDA 2003: GCP by SFDA 26 STATE FOOD AND DRUG ADMINISTRATION
Accreditation by Jun. 1, 23 Notice for Accreditation of Drug Clinical Trial Institutions issued by SFDA � 298 drug clinical trial institutions in 27 provinces, autonomous regions or municipalities � 3 hospitals in HK � For relevant information: www.sfda.gov.cn 27 STATE FOOD AND DRUG ADMINISTRATION
Page 1 and 2: Regulation <strong
Page 3 and 4: Approval of drug clinical trials 3
Page 5 and 6: Drug Administration Law � Article
Page 7 and 8: Different clinical trials �clinic
Page 9 and 10: Requirement for sponsors •qualifi
Page 11 and 12: Highlights of regulation on trials
Page 13 and 14: 13 new chemical compounds,1 new TCM
Page 15 and 16: 15 CDE � Highly professional team
Page 17 and 18: 17 MRCT � Main sponsors: big inte
Page 19 and 20: Challenges 19 Approval timeline Imp
Page 21 and 22: 21 MRCT in China: 2002 - 2008 STATE
Page 23 and 24: Risk-benefit Analysis � Benefits
Page 25: 25 GCP Implementation STATE FOOD AN
Page 29 and 30: 29 Clinical trial institutions abou
Page 31 and 32: 31 Clinical trial institutions Appr
Page 33 and 34: Comparison between China an
Page 35 and 36: Inspections � Supervisory inspect
Page 37 and 38: 1. improve legal and</stron
Page 39 and 40: Innovative drugs � While focusing
Page 41 and 42: Targets 41 set up a team of GCP ins
Page 43: 43 Thank you! STATE FOOD AND DRUG A

Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org

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