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…
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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: e986a24fd1dba0831f6747095ca484231c7c9e95f361835bbd4b987c11cc6275
Primary Citations — 6 traced to source
- Article 31 (marketing approval); Article 31-2 (priority review); Article 34 (clinical trial); Article 42 (overseas manufacturer); Article 68 (PMS); Chapter VIII (penalties) — Pharmaceutical Affairs Act (Act No. 901, 2023 Consolidation) - Ministry of Legislation
- ICH CTD dossier requirements; Korean Module 1 administrative requirements; review timelines; fee schedule; Korean package insert standards — MFDS - Drug Approval and Registration
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/south-korea-mfds-pharmaceutical-act-2023.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/south-korea-mfds-pharmaceutical-act-2023.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/south-korea-mfds-pharmaceutical-act-2023
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