KOR/1117
WTO/TBT
KR South Korea
  • 11 - Health care technology
2023-01-31
2022-12-05

Pharmaceuticals

Proposed partical amendments to the "Standard on Pharmaceutical Equivalence Test"; (41 page(s), in Korean)

The proposed amendment to the Standard on Pharmaceutical Equivalance Test is as follows:

1) Add standards for designating Reference Listed Drugs in accordance with the expanded scope of drugs subject to pharmaceutical equivalence study;

2) Harmonize bioequivalence criteria for narrow therapeutic index drugs with international standards;

3) Strengthen management of excipient changes by taking into consideration the formulations of products; and

4) Recalibrate pharmaceutical equivalence study document requirements for cases when manufacturing procedures and sites are changed