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  • MFDS, "will make all efforts to pass and land the 1+3 bill"
  • by Lee, Jeong-Hwan | translator Alice Kang | May 3, 2021 05:54am
¡°To limit co-development and prevent GMP violations¡¦ will make efforts to increase planning and monitoring personnel¡±
MFDS's responses to the National Assembly Health and Welfare Committee¡¯s written QA


The Ministry of Food and Drug Safety announced its plan to pass the revised Pharmaceutical Affairs Act at the National Assembly's plenary session and soft-land the system afterward. The revised Act contains a clause that limits the number of consignees to three for each company that conducts the bioequivalence test for generics and drugs requiring data submission (incrementally modified drugs, iMD).

The Ministry also reaffirmed its position regarding the 1+3 bill for generics and IMDs, on how the bill will partially resolve the rampant drug production issue in Korea, and have a positive influence on preventing recurrence of GMP violations of domestic pharmaceutical manufacturers like Binex and Vivozon.

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