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  • Impurity checks are left to the industry
  • by Lee, Tak-Sun | translator Choi HeeYoung | Dec 30, 2019 09:47pm
Pharmacy industry settled by 2019 administration and system by the MFDS
Establishment of fast permit requirement by passing advanced bio law

As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year. In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics.

Generic regulatory measures, including restrictions on cooperative and entrusted activities, the introduction of three batches of commissioned generic trial production, and mandatory licensed generic DMF, have already been implemented or heralded. Among them, the joint and consignment limit is an administrative notice announced in April, and the domestic pharmaceutical industry is under pressure and is keen to implement it.

Generic entry restrictions up to maximum aimed
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