KFDA requires bridge test data for product registration.

Taking effect from July the KFDA requires the bridge test data for any new drugs in their health registration process, and will recognize the toxicological test data from Jan. 1, 2003 only performed at the GLP standardized institutes.

So far the KFDA provision has required that the submission of the bridge test data was exempted for the new drug of over 3 years elapsed after its development ...