# Ministry of Food and Drug Safety (MFDS)

Source: https://onco.cc/institutions/mfds/  
OnCo record `mfds` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

South Korea's medicines regulator, which approves cancer drugs and clinical trials. It approved 783 drug trials in 2025, 304 of them for cancer medicines.

## Summary

The Ministry of Food and Drug Safety, based in the Osong life-science complex in Cheongju, licenses medicines and approves clinical trials in South Korea; its scientific review is carried out by its National Institute of Food and Drug Safety Evaluation. Its own press note of 30 June 2023 records that it first approved Yuhan's lazertinib (Leclaza), the 31st new drug developed in Korea, on 18 January 2021 for EGFR T790M-positive lung cancer after a previous EGFR inhibitor, more than three years before the United States approved it, and extended it to first-line treatment on 30 June 2023.

Its annual trial statistics for 2025, published on 6 March 2026, count 783 approved drug trials (747 in 2024), of which 668 were company-led and 115 investigator-led. Cancer medicines accounted for 304 (276 in 2024), about 68 per cent of them (207) targeted agents. Multinational trials rose from 372 to 425, while trials of medicines developed by Korean companies fell from 305 to 259. Its note for 2024 cites an analysis by the Korea National Enterprise for Clinical Trials ranking Korea sixth among countries and Seoul second among cities, after Beijing, for new company-led trials registered on ClinicalTrials.gov.

A revised new-drug review procedure started in January 2025, with a dedicated review team for each product and early inspection of manufacturing; trade press reported that it came with a fee of 410 million won per new drug application and a target of 295 days against an average of about 420. MFDS's own text on the fee and the target was not reached for this record.

## Fields

- Kind: Institution
- Last checked: 2026-11-03
- Also known as: MFDS; 식품의약품안전처; 식약처; Korea Food and Drug Administration; KFDA
- City: Cheongju (Osong), KR
- Type: government
- Website: https://www.mfds.go.kr

## Sources

- MFDS (Korean): https://www.mfds.go.kr
- MFDS press release, 6 March 2026: 2025 clinical trial approvals (Korean): https://www.mfds.go.kr/brd/m_99/view.do?seq=49738
- MFDS press release, 28 March 2025: 2024 clinical trial approvals (Korean): https://www.mfds.go.kr/brd/m_99/view.do?seq=48944
- MFDS press note, 30 June 2023: lazertinib first-line approval (Korean): https://www.mfds.go.kr/brd/m_99/view.do?seq=47414
- Daily Pharm, 6 February 2025: the 410 million won fee and 295-day target (Korean): https://www.dailypharm.com/user/news/8680

## Connected records

- institutions: [Health Insurance Review and Assessment Service (HIRA)](https://onco.cc/institutions/hira/), [National Health Insurance Service (NHIS), South Korea](https://onco.cc/institutions/nhis-korea/), [Pharmaceuticals and Medical Devices Agency](https://onco.cc/institutions/pmda/)
- drugs: [Lazertinib](https://onco.cc/drugs/lazertinib/)
- companies: [Yuhan Corporation](https://onco.cc/companies/yuhan/)
- key papers: [An empirical analysis of anti-cancer drug lags in South Korea](https://onco.cc/key-papers/paper-lee-anticancer-drug-lag-korea-inquiry-2025/)

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