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