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

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10 Control over samples � manufactured in GMP-compliant facility � with appropriate scope for trials � free supply to subjects STATE FOOD AND DRUG ADMINISTRATION
Highlights of regulation on trials in China •all clinical trials must be approved by SFDA prior to the approval by the ethics committee •clinical trials must be conducted in designated clinical hospitals •clinical hospitals jointly selected by SFDA <strong>and</strong> MoH as clinical pharmacology institutes • Chinese GCP as the guideline • lots of trials for generics 11 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: Requirement for sponsors •qualifi
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 and 26: 25 GCP Implementation STATE FOOD AN
Page 27 and 28: Accreditation by Jun. 1, 23 Notice
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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