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

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Legislation 1. Drug Administration Law 2. <strong>Regulation</strong>s for Implementation of the Drug Administration Law 3. Provisions for Drug Registration 4. Good Clinical Practice 5. Provisions for Accreditation of Drug Clinical Trial Institutes 4 STATE FOOD AND DRUG ADMINISTRATION
Drug Administration Law � Article 29 The dossier on a new drug research <strong>and</strong> development including the manufacturing process, quality specifications, results of pharmacological <strong>and</strong> toxicological study, <strong>and</strong> the related data <strong>and</strong> the samples shall, in accordance with the regulations of the drug regulatory department under the State Council, be truthfully submitted to the said department for approval, before clinical trial is conducted. Measures for verifying the qualifications of clinical study institutions for drugs shall be formulated jointly by the drug regulatory department <strong>and</strong> the administrative department for health under the 5 State Council. � Article 30 The institutions for non-clinical safety evaluation <strong>and</strong> study <strong>and</strong> clinical study institutions shall respectively implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) <strong>and</strong> Good Clinical Practice (GCP). The GLP <strong>and</strong> GCP shall be formulated by the department designated by the State Council. STATE FOOD AND DRUG ADMINISTRATION
Page 1 and 2: Regulation <strong
Page 3: Approval of drug clinical trials 3
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 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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