KR Südkorea
  • 30 - Pharmazeutische Erzeugnisse


Regulation on Safety of Pharmaceuticals, etc. (46 page(s), in Korean)

This is to determine the matters entrusted by the law and the details necessary for its implementation including monitoring the implementation of procedures and conditions necessary for Conditional Marketing Authorization (CMA) and establishing Standard Operation Procedure (SOP) for Site Management Organization (SMO) and the Central Institution Review Board (IRB), following the revision of 'Pharmaceutical Affairs Act' (Act No.18307, Promulgation Date, 20 Jul, 2021, Enforcement Date, 21 Jan, 2022), which aims to provide legal basis on CMA which authorizes marketing under the condition that clinical trials result for the medicine user should be submitted and clinical trials consigned and conducted by IRB.