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Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D.

Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003. Regulatory Reform in Clinical Trials.

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Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D.

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  1. Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003

  2. Regulatory Reform in Clinical Trials • July 7 Announcement (1993): An approved study report of a local clinical trial is required for the new drug application in Taiwan • Double 12 Announcement (2000): Bridging Studies *2001: BSE optional; BS optional if not waived *2003: BSE mandatory; BS optional if not waived *2004: BSE mandatory; BS only if not waived

  3. Current Checklist for Assessing Ethnic Sensitivity

  4. Results for BS Evaluation (I)(01/2001-8/2003) • Application－74 cases Asian data 33 (53%) • Case evaluated (62) 29 (47%) No Asian data Asian data 26 (79%) • BS waived (49)(79%) 23 (79%) No Asian data

  5.  13 cases-bridging study not waived (21 %) ★ Concerns of drug-drug interactions; ★ Concerns of dose adjustment

  6.  13 cases-bridging study not waived (21 %)

  7. Recommended Checklist for Assessing Ethinic Sensitivity <Ref> Lin et al. DIA 37: 143-145, 155-158, 2003

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