(1) Reasons for Proposal

This Partial Amendment aims to ensure quality reliability for generic drugs by preparing equivalence evaluation standards reflecting the characteristics of delayed release drugs and harmonizing equivalence acceptance criteria in a comparative dissolution test with international standards, while reflecting the amended upper-level law to improve and supplement regulations.

(2) Major Provisions

A. Strengthen equivalence evaluation standards for delayed release drugs (Articles 14 and 15)

To reflect the characteristics of delayed release drugs, add a postprandial bioequivalence test as a requirement to submit in equivalence evaluation to reinforce the reliability of generic drugs.

B. Harmonize regulations for acceptance criteria on dissolution pattern equivalence (Article 21, and attached Table 6)

While either difference in the mean dissolution rate or the similarity factor could be previously selected as the equivalence acceptance method in a comparative dissolution test, harmonize regulations in a way that only the similarity factor can be used to determine whether equivalence is acceptable.

C. Expand the applicable scope of a drug equivalence test in accordance with the upper-level law (Article 3, and attached Tables 2, 3, and 4)

Reflect the amendment of the Rules on the Safety of Drugs, etc., (Ordinance of the Prime Minister No. 1650; October 14, 2020) which makes all prescription drugs subject to a bioequivalence test.

D. Define the level of change and documentation to be submitted when changing a production method or place (attached Tables 2, 3, and 4)

In relation to stricter management for any change in prescription drug production methods under Article 3-2 of the Administrative Pre-Announcement of the Rules on the Safety of Drugs, etc., (Notice No. 000; December 00, 2020) explicitly define the level of change and documentation to be submitted in an effort to increase predictability for the applicant. 

E. Harmonize bioequivalence test exemption standards with international ones in accordance with the Biopharmaceutics Classification System (Article 7, and attached Table 5)

Expand those exempted from a bioequivalence test to be in line with the ICH M9 Guidelines.

F. Add the physicochemical equivalence test evaluation form (attached Form 6)

Make it easier for the applicant to fill out documentation by adding the physicochemical equivalence test evaluation form.