Remark:

1.  Apply for waiving bridging studies with reference to DOH announcements of waiving clinical trials. If the drug falls within the category that “requires submission of information proving no existence of ethnic differences”, it should be evaluated following this flowchart after the one year phase-in period.
2. ICH E5 and DOH Guidance on Clinical trials.
3. Under circumstances when evidence indicating potential intrinsic/extrinsic differences between Chinese and other Asian populations, a bridging study in Chinese population is a must.
4.  A bridging study will be required when there exists any safety concern.
5.  A bridging study can be a PK and/or PD study or any clinical study that can demonstrate the efficacy and safety of the medicine.