(1) Reasons for Proposal
The amendment aims to improve the safety, efficacy, and quality of generic pharmaceuticals by improving outsourced (joint) bioequivalence tests and international balance of generic pharmaceutical permission standards.

(2) Major Provisions
A. Require the inclusion of the pharmaceuticals to be reviewed for safety and efficacy such as special dosage forms (prolonged-release dosage form, etc.), injections whose additives differ from existing permissions, ophthalmic solutions, and otic solutions when preparing the Common Technical Document (CTD) (Article 6)
B. Although Regulations require the submittal of data on the manufacturing methods of injections, there arises confusion because the Regulations do not address specific data, and thus, the amendment aims to address required specific data (Article 14)
C. Make it mandatory to submit stability study data when changing direct containers of pharmaceuticals (Article 19, Article 25, and Article 27)
D. Promote the development of pharmaceuticals for children, assigning a reassessment when pharmaceuticals for children are permitted through clinical trials both in Korea and abroad (Article 22)
E. Exempt the data of study methods and criteria to be submitted as physicochemical equivalence test data and clarify the basis for the data submission by setting the test items in consideration of the physicochemical properties of dosage forms (Article 27)
F. Require that a bioequivalence test be conducted even when being outsourced to the manufacturing site where an item has already gone through the bioequivalence test (Article 28)