KOR/831
WTO/TBT
KR South Korea
  • 30 - Pharmaceutical products
2019-07-26
2019-05-28

Pharmaceuticals

Proposed Amendments to the Regulation on the Registration of Active Pharmaceutical Ingredient (7 page(s), in Korean)

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is issuing the proposed amendments to the MFDS Notice "Regulation on the Registration of Active Pharmaceutical Ingredient" as stated below. The amendments are intended to manage the Drug Master File (DMF) more efficiently. The active pharmaceutical ingredients (APIs) used for manufacturing of the already approved drugs whose pharmaceutical equivalence needs to be verified are now subject to registration under the amendment.