What South Korea MFDS Pharmaceutical Affairs Act 2023 - Drug Approval, GMP Inspection and Pharmacovigilance requires
South Korea's Pharmaceutical Affairs Act (PAA, Act No. 901, 29 December 1953, consolidated to 2023) administered by the Ministry of Food and Drug Safety (MFDS - Sikhum-uiyakhum) regulates drug marketing approval (품목허가 - pumok heoga), GMP inspection of domestic and overseas manufacturing facilities, pharmacovigilance, clinical trial authorisation, and good distribution practices; Korea adopted the ICH Quality, Safety, and Efficacy guidelines; MFDS participates in PIC/S (Pharmaceutical Inspection Co-operation Scheme) and the International Coalition of Medicines Regulatory Authorities (ICMRA); fines up to KRW 30 million and product market withdrawal apply for violations.
Pillar: Pharmaceuticals & Life Sciences · Authority: Ministry of Food and Drug Safety (MFDS - Sikhum-uiyakhum), Republic of Korea · Version: 1.0.0 · Last updated:
Primary source: https://www.mfds.go.kr/
SHA-256 integrity: c94a0287525708776bcd26323754c4c6db2814a8802e007b80907f67fa81aa0e
Primary Citations — 6 traced to source
- {"title":"Pharmaceutical Affairs Act (Act No. 901, 2023 Consolidation) - Ministry of Legislation","url":"https://www.mfds.go.kr/","section":"Article 31 (marketing approval); Article 31-2 (priority review); Article 34 (clinical trial); Article 42 (overseas manufacturer); Article 68 (PMS); Chapter VIII (penalties)"}
- {"title":"MFDS - Drug Approval and Registration","url":"https://www.mfds.go.kr/eng/brd/m_30/view.do","section":"ICH CTD dossier requirements; Korean Module 1 administrative requirements; review timelines; fee schedule; Korean package insert standards"}
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