Overview
From 1 to 30 September 2025 the Korean Ministry of Food and Drug Safety (MFDS) issued 62 approvals for investigational new drugs (INDs). Of these, 15 were for compounds developed domestically and 47 for products developed overseas, meaning about 76 % of the approvals related to foreign‐developed candidates. The approvals covered a range of areas, including oncology, rare diseases and metabolic disorders, underscoring Korea’s status as a global hub for clinical research.
Approvals and phase distribution
The dataset shows that third‐phase studies accounted for 26 approvals, first‐phase trials for 15, and phase 1/2 and phase 2 trials for 6 and 5 approvals respectively. Other stages such as phase 2a, 3b or 2/3 were single‐digit totals. The high share of late‐stage (phase III) trials suggests that many products have already cleared early safety evaluations and are now verifying efficacy, and that global pharmaceutical companies are actively extending their development programmes in Korea.
Domestic vs. foreign development
One reason the majority of approvals are for foreign‐developed drugs is that overseas sponsors must work with a domestic clinical research organisation (CRO) when conducting trials in Korea. Collaborating with a local CRO allows multinationals to use Korea’s clinical infrastructure and diverse patient population, making the country an attractive destination for IND filings. Domestic approvals largely consisted of early‐stage projects led by small biotech companies, which reflects the growing momentum of the local biotech ecosystem.
Key sponsors and research trends
The largest number of approvals came from PPD Development Pte Ltd (6 approvals). Other leading sponsors were Parexel Korea and AstraZeneca Korea (four approvals each). A review of trial titles and indications shows that oncology dominated. Many projects investigated new targeted therapies, immuno‑oncology agents and even radiopharmaceuticals. Trials also addressed chronic kidney disease, gastrointestinal and metabolic disorders, and several evaluated pharmacokinetic profiles and safety in paediatric or elderly patients. These patterns suggest Korean trials are maintaining therapeutic diversity while keeping pace with global research trends.
Regulatory environment
Korea offers a world‑class clinical environment built on modern healthcare facilities and skilled professionals. MFDS is the central authority that reviews trial protocols and verifies safety and ethics, and studies cannot start without parallel approval from an institutional review board (IRB). The Korean Good Clinical Practice (KGCP) standard aligns with the International Council for Harmonisation (ICH) guidelines, while the Personal Information Protection Act and MFDS guidelines impose strict requirements for data privacy and security. Sponsors must also report adverse events promptly and continuously monitor safety. Foreign sponsors are required to engage a domestic CRO partner and disclose trial outcomes via the Clinical Research Information Service (CRIS), enhancing transparency and reliability.
Conclusion
The September 2025 MFDS IND approvals confirm that Korea remains an attractive research venue for both multinational pharmaceutical companies and local biotechs. The 62 approvals represent an increase over the same period of the previous year, and the high proportion of phase III trials shows that drug development is advancing rapidly. Although foreign‑developed products still dominate, domestic participation is gradually expanding. Combined with strict yet efficient regulatory oversight, compliance with global standards and robust privacy protections, these factors underpin Korea’s evolution into a clinical research hub not only for Asia but for the world.
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