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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.

October 28, 2003


Regulatory reform in clinical trials
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



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


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

★ Concerns of drug-drug interactions; ★ Concerns of dose adjustment



Recommended Checklist for Assessing Ethinic Sensitivity

<Ref> Lin et al. DIA 37: 143-145, 155-158, 2003


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