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  • Bioequivalence reevaluation may hinder drug license renewal
  • by Lee, Tak-Sun | translator Byun Kyung A | Apr 1, 2020 06:21am
MOHW plans to revive bioequivalence reevaluation and tighten renewal review
Drug industry ¡°Needs consistent review approach with detailed standards¡±
Korean pharmaceutical industry is voicing their concerns about the Ministry of Food and Drug Safety¡¯s (MFDS) plan to revive bioequivalence reevaluation and to toughen the item license renewal review procedure.

Arguing the government¡¯s redundant review could harm them, the industry claims the ministry should set down more consistent review approach to avoid having a series of contradicting review results.

The industry sources reported on Mar. 31, MFDS has unveiled the first Master Plan for Pharmaceutical Safety Management (valid from 2020 to 2024) containing details of reviving bioequivalence reevaluation and strengthening license renewal review.

The ministry means to enhance credibility of approved dru
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