South Korea
Ministry of Food and Drug Safety (MFDS) · Asia-Pacific
Executive summary
South Korea operates one of Asia's most sophisticated regulatory systems through the Ministry of Food and Drug Safety (MFDS, formerly KFDA), an independent ministerial agency reporting to the Prime Minister. Drug authorisation is granted under the Pharmaceutical Affairs Act (PAA). MFDS joined ICH in 2016 and PIC/S in 2014 and has progressively converged with ICH and EMA standards. Korea is a global leader in biosimilars (Celltrion, Samsung Bioepis) and a rapidly growing innovator hub. The Global Innovative Products on Fast Track (GIFT) programme provides expedited review for innovative therapies. Conditional approval, orphan, and paediatric pathways are actively used. Reimbursement on the Health Insurance Review and Assessment Service (HIRA) positive list is largely mandatory for commercial success. The Korea National Enterprise for Clinical Trials (KoNECT) supports a strong clinical trial environment, with Korea consistently ranked top-5 globally for trial volume per capita.
About the authority
MFDS comprises the Drug Evaluation Department (which contains the New Drug Division, Generic Drug Division, Biopharmaceutical Division, and others) and operates regional MFDS offices for inspections. The National Institute of Food and Drug Safety Evaluation (NIFDS) provides scientific evaluation support. MFDS has aggressively pursued international convergence — eCTD acceptance, ICH Q12 implementation, biosimilar guidelines aligned with EMA.
International affiliations
Reliance & recognition
MFDS does not operate a formal reliance pathway but actively accepts foreign clinical data and assessment reports. PIC/S membership means GMP inspections by partner authorities are recognised. The ACCESS Consortium observer role indicates direction toward more formal work-sharing. Joint reviews with FDA under Project Orbis (oncology) and bilateral confidential exchanges with EMA, PMDA, FDA are routine.