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

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Professional background of CDE 14 STATE FOOD AND DRUG ADMINISTRATION
15 CDE � Highly professional team � focus on drug evaluation, while also involved with drug clinical trial regulatory system � Take the lead in introducing international evaluation system <strong>and</strong> concepts � Heavy workload, lack of human resources � st<strong>and</strong>ardized, independent, science-based <strong>and</strong> transparent � Active in international activities, e.g. dialogue with US FDA, EMA 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: 13 new chemical compounds,1 new TCM
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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