[Press Release, Apr. 16, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has published a “Guidance on Cardiovascular Safety Pharmacology Evaluation Method”, which aims to help pharmaceutical companies better develop and market drugs. ...

[Reference for Press Release, Apr. 14, 2021 / Unofficial Translation] □ On April 14, 2021, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) preannounced an administrative notice of an amendment to the “Regulation on Evaluation of Testing and Inspection Laboratories in the F...

[Press Release, Apr. 12, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that Green Cross Corporation, or GC Pharma, filed an application for the Moderna COVID-19 vaccine’s marketing authorization. ○ The Moderna COVID-19 vaccine,...

[Press Release, April 7, 2021 / Unofficial Translation] □ Following the Janssen Korea's application for the marketing authorization of the Janssen COVID-19 vaccine on February 27, 2021, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted a marketing authorization to the vacc...

[Reference for Press Release, April 7, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has established and published two sets of “Usability Guidelines for Medical Devices” to raise awareness of medical device usability requirements, w...

[Reference for Press Release, Apr. 6, 2021 / Unofficial Translation] On April 6, 2021, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) will hold the “Consultation Meeting for Supporting COVID-19 Vaccine Quality Management”with vaccine developers who are cur...

[Press Release, Apr. 1, 2021 / Unofficial Translation] 1. Current Review Status for Marketing Authorization □ On April 1, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) held a Central Pharmaceutical Advisory Committee (CPAC) meeting at its headquarters in Osong to seek advic...

[Reference for Press Release, Mar. 30, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has published “Guidance on Import Procedures for Hygiene Products”, which explains what importers of hygiene products should know....

[Press Release, Mar. 29, 2021 / Unofficial Translation] 1. Current Marketing Authorization Review Status □ On March 28, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) held a meeting of the COVID-19 Vaccine Safety and Clinical Efficacy Advisory Committee (hereinafter Advisory...

[Press Release Mar. 28, 2021 / Unofficial Translation] □ On March 28, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) approved the lot release of Comirnaty Inj. for 250,000 people (or 500,000 doses), which was filed by Pfizer Korea. ○ The lot release for Comirnaty w...