Total 100Articles, Present Page 1/10
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100MFDS Establishes Evaluation Methods for Cardiovascular Safety Pharmacology [Press Release, Apr. 16, 2021][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. ...
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(4.16) MFDS Establishes Evaluation Methods for Cardiovascular Safety Pharmacology.pdf
2021-04-16 -
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99Evaluation Standards for Testing and Inspection Laboratories Revised in Accordance with International Standards [Reference for Press Release, Apr. 14, 2021][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...
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(4.14) Evaluation Standards for Testing and Inspection Laboratories Revised in Accordance with International Standards.pdf
2021-04-15 -
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98MFDS begins Review of Moderna COVID-19 Vaccine [Press Release, Apr. 12, 2021][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,...
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(4.12) MFDS Begins Review of Moderna COVID-19 Vaccine.pdf
2021-04-13 -
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97MFDS Grants Marketing Authorization for Janssen COVID-19 Vaccine [Press Release, Apr. 7, 2021][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...
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(4.7) MFDS Grants Marketing Authorization for Janssen COVID-19 Vaccine.pdf
2021-04-08 -
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96New Guidance on Usability Requirements for Medical Device Manufacturers [Reference for Press Release, Apr. 7, 2021][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...
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(4.7) New Guidance on Usability Requirements for Medical Device Manufacturers.pdf
2021-04-07 -
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95MFDS Holds a Consultation Meeting to Support COVID-19 Vaccine Quality Management [Reference for Press Release, Apr. 6, 2021][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...
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(4.6) MFDS Holds a Consultation Meeting to Support COVID-19 Vaccine Quality Management.pdf
2021-04-06 -
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94Central Pharmaceutical Advisory Meeting Outcomes on Janssen COVID-19 Vaccine [Press Release, Apr. 1, 2021][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...
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(4.1) Central Pharmaceutical Advisory Meeting Outcomes on Janssen COVID-19 Vaccine.pdf
2021-04-02 -
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93Import Procedure for Hygiene Products Explained [Reference for Press Release, Mar. 30, 2021][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....
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(3.30) Import Procedure for Hygiene Products Explained.pdf
2021-03-30 -
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92Advisory Committee Meeting Outcomes on Janssen COVID-19 Vaccine [Press Release, Mar. 29, 2021][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...
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(3.29) Advisory Committee Meeting Outcome on Janssen COVID-19 Vaccine.pdf
2021-03-30 -
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91Pfizer COVID-19 Vaccine Comirnaty Lot Release Approved for 250,000 People [Press Release, Mar. 28, 2021][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...
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(3.28) Pfizer COVID-19 Vaccine Comirnaty Lot Release Approved for 250,000 People.pdf
2021-03-30 -