Pharmaceuticals

Proposed amendments to the Regulation on Safety of Pharmaceuticals, etc.; (43 page(s), in Korean)

This amendment clarifies specific dispositions criteria - such as the cancellation of GMP compliance determination in case of violation by medicinal product manufacturers - which is in relation to the amendments of the "Regulations on Drug Safety Notice No. 2022-436"(notified on September 30, 2022), of which the amendment was made to define the dispositions criteria for GMP compliance determination cancellation in accordance with Article 41 of the Administrative Procedures Act.