Bioequivalence testing to become compulsory for all ingredients of combined preparations, KFDA says

From October 27, generic combination drugs to be produced in Korea must prove they are equivalent to the patented medicines on which they are modeled.

Those applicants who intend to seek approval of the generic combination products containing three ingredients should conduct bioequivalence testing for each active ingredient, according to a Q/A document published by the Korea Food and Drug Ad...