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  • Bioequivalence reevals speed up in line with drug price reev
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Sep 21, 2023 05:24am
Authorities plan to strengthen communication with the industry... CHORUS¡¯s 2H workshop set for this November
MFDS plans to require all generic prescription drugs to be subject to equivalence tests from this year
With the number of items requiring equivalence tests expanded as such, the Ministry of Food and Drug Safety is also accelerating the reevaluation of those that were previously approved. In particular, it is said that the review is being further accelerated this year as its timing overlaps with the reevaluation of the insurance price ceiling amount, which requires self-bioequivalence tests.

So-Hee Kim, Director of the Bioequivalence Evaluation Division at the Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation, said so at a press briefing it had held together with the Drug Evaluation Department.

Director Kim explained, "The initial results of the Ministry of Health and Welfare's
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