1. Reasons for Amendment

As the Pharmaceutical Affairs Act was revised (Act No. 18970, promulgated on June 10, 2022, and effective on December 11, 2022) to provide the basis for the suitability decision to the manufacturing and quality management practice for drugs, etc. (hereinafter referred to as “GMP”), this amendment aims to determine the matters entrusted by Ordinance of the Prime Minister, such as detailed dosage forms of drug products subject to GMP suitability decision.

2. Major Provisions

A. Detailed dosage forms for GMP suitability decision (Article 2-4)

Maintain appropriateness in the issuance of a written GMP suitability decision by defining the detailed dosage forms of drug products subject to GMP suitability decision.