Total 153Articles, Present Page 6/16
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103MFDS Begins Rolling Review of Novavax COVID-19 Vaccine [Press Release, April 29, 2021][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...
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(4.29) MFDS Begins Rolling Review of Novavax COVID-19 Vaccine.pdf
2021-05-03 -
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102MFDS Publishes Q&A Guidance on Development of COVID-19 Therapeutics & Vaccines [Press Release for Reference, April 30, 2021][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...
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(4.30) MFDS Publishes Q&A Guidance on Development of COVID-19 Therapeutics & Vaccines.pdf
2021-04-30 -
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101MFDS Adopts E-Receipt for Samples Collected for Imported Food Inspection [Press Release, April 23, 2021][Press Release, April 23, 2021/ Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that from May 2021, e-receipt will be used in place of the current paper-based receipt for product samples collected for imported food inspection. ※ Receipt...
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(4.23) MFDS Adopts E-Receipt for Product Samples.pdf
2021-04-26 -
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100MFDS Establishes Evaluation Methods for Cardiovascular Safety Pharmacology [Press Release, April 16, 2021][Press Release, April 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 [Press Release for Reference, April 14, 2021][Press Release for Reference, April 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 ...
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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, April 12, 2021][Press Release, April 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, April 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 [Press Release for Reference, April 7, 2021][Press Release for Reference, 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 currently condu...
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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, April 1, 2021][Press Release, April 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 advi...
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(4.1) Central Pharmaceutical Advisory Meeting Outcomes on Janssen COVID-19 Vaccine.pdf
2021-04-02 -