Who is the medicines regulator in South Korea?

MFDS is the medicines regulator for South Korea. They evaluate, license, and inspect medicines in scope.

How many drugs are approved in South Korea?

Drug Landscape tracks 500 drug approvals in South Korea. Each entry links back to the manufacturer and full regulatory record.

South Korea — Pharmaceutical Approvals & Pricing

MFDS · 500 approvals · 0 pricing records

MFDS is the medicines regulator for South Korea. This page lists every drug we have a tracked approval or pricing record for in South Korea.

Approvals

Ofev · Boehringer Ingelheim · Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Keytruda · Merck & Co. · Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Aczone · Almirall · Wed Apr 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Aczone · Almirall · Fri Apr 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Pivamdinocillin · Sykehuset i Vestfold HF · Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Veopoz · Regeneron · Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Zurzuvae · Biogen · Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Vanflyta · Daiichi Sankyo Inc · Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
ROLVEDON · SPECTRUM PHARMS · Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Inpefa · Lexicon Pharms Inc · Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Posluma · Blue Earth · Thu May 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Miebo · Bausch Health · Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Ophthalmology
Veozah · Astellas Pharma · Fri May 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Elfabrio · Chiesi Farmaceutici S.P.A · Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Qalsody · Biogen Ma · Tue Apr 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Rare Disease
Jesduvroq · GSK · Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Orserdu · Stemline Therap · Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Tzield · Provention Bio Inc · Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Bcmaxcd3 · Johnson & Johnson · Tue Oct 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Sotyktu · Bristol-Myers Squibb · Fri Sep 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Spevigo · Boehringer Ingelheim Pharmaceuticals Inc · Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Amvuttra · Alnylam Pharmaceuticals · Mon Jun 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Mounjaro · Eli Lilly · Fri May 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Vivjoa · Mycovia Pharms · Tue Apr 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Pluvicto · Aaa Usa Novartis · Wed Mar 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Ztalmy · Marinus · Fri Mar 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Enjaymo · Bioverativ Therapeutics Inc · Fri Feb 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Leqvio · Novartis · Wed Dec 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Livmarli · Mirum Pharma Inc · Wed Sep 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Exkivity · Takeda · Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Bylvay · Ipsen · Tue Jul 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Fexinidazole · Sanofi · Fri Jul 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Kerendia · Bayer · Fri Jul 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Lumakras · Amgen · Fri May 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Lybalvi · Alkermes Inc · Fri May 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Azstarys · Commcave Therapeutics Sa · Tue Mar 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Nulibry · Sentynl Theraps Inc · Fri Feb 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Verquvo · Merck & Co. · Tue Jan 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Cardiovascular
Klisyri · Almirall · Mon Dec 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Other
Locametz · Univ Ca Los Angeles · Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Oxlumo · Alnylam Pharmaceuticals · Mon Nov 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Zokinvy · Sentynl Theraps Inc · Fri Nov 20 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Veklury · Gilead Sciences · Thu Oct 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Winlevi · Sun Pharma · Wed Aug 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Dermatology
Viltepso · Nippon Shinyaku · Wed Aug 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Rare Disease
Olinvyk · Trevena · Fri Aug 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Inqovi · Otsuka · Tue Jul 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Rukobia · GSK · Thu Jul 02 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Tauvid · Avid Radiopharms Inc · Thu May 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Retevmo · Eli Lilly · Fri May 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Keytruda · Merck & Co. · Tue Apr 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Zeposia · Bristol-Myers Squibb · Wed Mar 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Isturisa · Recordati · Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Respiratory
Ubrelvy · AbbVie · Mon Dec 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Enhertu · Daiichi Sankyo · Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Vyondys 53 · Sarepta · Thu Dec 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Rare Disease
Oxbryta · Global Blood Theraps · Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Trikafta (Copackaged) · Vertex Pharms Inc · Thu Oct 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Respiratory
Torisel · Pfizer · Fri Aug 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Wakix · Harmony · Wed Aug 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Busulfex · Waylis · Fri Feb 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Vitrakvi · Bayer · Mon Nov 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Yupelri · Mylan Ireland Ltd · Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Respiratory
Talzenna · Pfizer · Tue Oct 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Onpattro · Alnylam Pharmaceuticals · Mon Oct 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Revcovi · Leadiant Biosci Inc · Fri Oct 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Nuzyra · Paratek Pharms · Tue Oct 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Ajovy · Teva · Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Xerava · Tetraphase Pharms · Mon Aug 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Mulpleta · Vancocin Italia · Tue Jul 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Cardiovascular
Torisel · Pfizer · Mon Jul 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Moxidectin · Mdgh · Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Trogarzo · Taimed Biologics Usa · Tue Mar 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Lutathera · Aaa Usa Inc · Fri Jan 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Vabomere · Rempex Pharms Inc · Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Besponsa · Pfizer · Thu Aug 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Radicava · Kk Bcj-94 · Fri May 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Cardiovascular
Dupixent · Regeneron · Tue Mar 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Lartruvo · Eli Lilly · Wed Oct 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Exondys 51 · Sarepta · Mon Sep 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Rare Disease
Xiidra · Bausch Health · Mon Jul 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Nuplazid · Acadia Pharms Inc · Fri Apr 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Neuroscience
Defitelio · Jazz Pharms Inc · Wed Mar 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Anthim · Elusys Therapeutics Inc · Fri Mar 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Other
Zepatier · Merck & Co. · Thu Jan 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Zurampic · Ironwood Pharms Inc · Tue Dec 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Vonvendi · Baxalta US Inc. · Tue Dec 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Portrazza · Eli Lilly Co · Tue Nov 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Vemlidy · Gilead Sciences · Thu Nov 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Immunology
Yondelis · Janssen Prods · Fri Oct 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Viberzi · AbbVie · Wed May 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Pain
Cholbam · Mirum · Tue Mar 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Cresemba · Astellas Pharma · Fri Mar 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Infectious Disease
Farydak · Secura · Mon Feb 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Ofev · Boehringer Ingelheim · Wed Oct 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Akynzeo · Helsinn Hlthcare · Fri Oct 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Trulicity · Eli Lilly · Thu Sep 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic
Auryxia · Keryx Biopharms · Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Hematology
Keytruda · Merck & Co. · Thu Sep 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Oncology
Perikabiven In Plastic Container · Fresenius Kabi · Mon Aug 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time) · likely_approved · Metabolic

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