1. Reasons for Amendment

This partial amendment will harmonize the scope of application of the pharmaceutical equivalence test with associated laws and regulations, and develop an additional standard for selecting comparators so as to improve and complement the scope of data to be submitted according to the degree of modification to the bioequivalence assessment standards of pharmaceutical drugs whose treatment area is narrow and the content of pharmaceutical ingredients.

2. Major Provisions

A. Make sure the pharmaceutical drugs that are required to undergo pharmaceutical equivalence testing coincide with the scope of application set out under Articles 18 and 21 in the Narcotics Control Act (Article 3)

B. Modify the comparator selection standards and develop additional standards according to the expanded scope of drugs subject to pharmaceutical equivalence testing (Article 3-2)

Develop the comparator selection standards for items newly added according to the gradual expansion of the scope of drugs subject to pharmaceutical equivalence testing

C. Harmonize the types of pharmaceutical drugs with narrow treatment areas and the bioequivalence assessment standards with international standards (Article 17, attached Table 1).

When adding and assessing the equivalence of a pharmaceutical drug with a narrow treatment area, set the confidence interval of the pharmacokinetic parameters to a narrow scope.

D. Set the scope of data to be submitted according to the degree of modification to ingredient drugs and quantity by dosage form (attached Table 2)

Harmonize the degree of content modification according to the difference in the content in the total weight of the unit dosage form.