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Assessment of the Extrapolation of Foreign Clinical Data for Registration Purposes

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Abstract

The assessment of the acceptability of the extrapolation of foreign clinical data to a new region for registration purposes, known as the process of “bridging study evaluation,” started in Taiwan on January 1, 2001. Established in compliance with the International Conference on Harmonisation E5 guidance, this process was enacted to gradually replace the “registration trial” as a basis for registration of medications in the Asian region. Since its implementation, Taiwan’s Center for Drug Evaluation has received and evaluated 20 applications. Of these, 12 (60%) were considered to be ethnically acceptable and 8 (40%) were considered ethnically sensitive due to reasons such as their pharmacodynamic/pharmacokinetic characteristics, concerns about their efficacy and safety in the Taiwanese population, and extrinsic factors leading to ethnic differences.

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References

  1. 1.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5). Geneva, Switzerland: ICH; 1998.

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    Naito C. Necessity and requirements of bridging studies and their present status in Japan, lnt J Clin Pharmacol Ther. 2000;38:80–86.

  3. 3.

    Hsiao ML. The current status of clinical trials and GCP in Taiwan. Drug InfJ. 1998;32:1203S–1207S.

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Author information

Correspondence to Yeong-Liang Lin MD.

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Lin, Y., Chiou, Y.J., Hsiao, C. et al. Assessment of the Extrapolation of Foreign Clinical Data for Registration Purposes. Ther Innov Regul Sci 36, 513–516 (2002). https://doi.org/10.1177/009286150203600306

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Key Words

  • Foreign
  • Efficacy
  • Safety
  • Bridging study
  • Ethnic factors