[Press Release for Reference, June 15, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) published on June 15 the "2020 APEC Harmonization Center (AHC) Annual Report" both in Korean and English to share AHC's activities in medical Products regulato...

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announce an advance administrative notice on June 10 and receive opinions on the revision of 「Standards and Specifications for Health Functional Food」, which include addition of warning notice for intake of 8 functional ingredients*...

[Press Release for Reference, May 16, 2021 / Unofficial translation] □ According to a joint analysis on clinical trial authorizations, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) and the Korea National Enterprise for Clinical Trials (KoNECT, President Bae Byoungjun) announce...

[Press Release for Reference, May 10, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) made an administrative pre-announcement on May 10 on the revision of the “Regulations on Inspection of Imported Foods, etc.”, which includes adjustm...

[Press Release, May 10, 2021 / Unofficial Translation] 1. Current Marketing Authorization Review Status □ On May 9, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) convened a meeting of the COVID-19 Vaccine Safety and Clinical Efficacy Advisory Committee (hereinafter “the...

[Press Release, May 4, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that KeraSkinTM Skin Irritation Test (SIT), a locally developed alternative method to animal testing, was approved as an OECD Test Guideline (TG) in the 33rd Wor...

[Press Release April 30, 2021 / Unofficial Translation] On April 30, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) released the revision of The Guidelines on Review and Approval of AR/VR-Based Medical Devices which is aimed at improving safety review method and clarifying prod...

[Press Release, April 29, 2021 / Unofficial Translation] The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that Huons Co., Ltd. filed for rolling review of Russia’s Sputnik V COVID-19 vaccine on April 29 prior to submitting an application for marketing authoriz...

[Press Release, April29, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that SK Bioscience filed for a rolling review* of the Novavax COVID-19 vaccine on April 29 before submitting an application for marketing authorization. * Rolling...

[Press Release for Reference, April 30, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has published a “Q&A Guidance on the Development of COVID-19 Therapeutics and Vaccines” based on pre-submission consultations on R&D and c...