Bridging Study Evaluation

　　　To fulfill the spirit of ICH-E5, reduces repetitions of clinical trials and integrates ethnic concerns into global drug development programs, DOH announced the Bridging Study on December 12,2000. If ethnic concerns are considered during the early stage of drug development, there may be no need to conduct bridging studies in Taiwan. By the end of 2006, among 234 evaluations to wave the bridging studies, 146 of them received permission with a permission rate of 62.4%. For those rejected, they are encouraged to discuss with CDE based on the synopsis of bridging studies prepared by the sponsor.

　　　Based on the five DOH announcements officially issued by DOH between 1998 and 2004, alternative track to waive local clinical trial were provided. By the end of 2006, among 136 applications evaluated, 92 cases received permission. The permission rate was 67.6%.

If you want to get more informations, please visit "The Bridging Study Site"

Checklist for the Evaluation of Bridging Study by the Sponsor