Bridging study evaluation (BSE) is a process required before or with NDA submission in Taiwan. The purpose of BSE is to evaluate if there is any ethnic difference. The study aims to evaluate the relationship between BSE results and the present of Asian clinical and/or PK data in the BSE package.
Taiwan Center for Drug Evaluation (TCDE) has reviewed the technical dossiers of BSE applications since 2004. Cases with Asian data gained waiver or non-waiver of bridging study are analyzed. We also analyze the deficiencies of the non-waiver cases.
More than 400 BSE applications were submitted since 2004. The percentage of cases with Asian data increased from 54% to over 80%. Overall, about 80% of cases with Asian data gained waiver of bridging study. For the non-waiver cases with Asian data, frequent deficiencies include: the Asian data are too limited to evaluate ethnic difference; the Asian PK and/or clinical data shows ethnic difference; and improper design of the Asian study.
There is a trend of more and more Asian data being submitted. Cases with Asian data have a higher probability to gain bridging study waiver.