Total 151Articles, Present Page 9/16
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71MFDS to Lead International Regulatory Harmonization of Medical Devices in 2021 [Press Release, Jan. 21, 2020][Press Release, Jan. 21, 2020 / unofficial translation ] MFDS to Lead International Regulatory Harmonization of Medical Devices in 2021- Korea serves as the chair country of the International Medical Device Regulators Forum (IMDRF) -
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(01.21) Leading International Regulatory Harmonization of Medical Devices in 2021(IMDRF).pdf
2021-02-01 -
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70Contact “14-3330” to access the Relief System for Adverse Drug Reaction [Press Release, Jan 20, 2020][Press Release, Jan 20, 2020 / Unofficial translation] Contact “14-3330”to access the Relief System for Adverse Drug Reaction - New hotline offers easier access to information and consultations -
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(1.20) 14-3330 Relief System for Adverse Drug Reaction.pdf
2021-01-21 -
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69Updates on the approval and review of COVID-19 therapeutics and vaccines (1) [Press Release, Jan 11, 2020][Press Release, Jan 11, 2020 / unofficial translation ] Updates on the approval and review of COVID-19 therapeutics and vaccines (1) □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) provides the following clarifications regarding the marketing approval of a COVID-19 ther...
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(210111) Updates on the approval and review of COVID-19 therapeutics and vaccines (1).pdf
2021-01-18 -
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68Nine substances including crotonylfentanyl designated as narcotics or precursors [Press Release, Jan 5, 2020 ][Press Release, Jan 5, 2020 / unofficial translation ] Nine substances including crotonylfentanyl designated as narcotics or precursors - Promulgation of the amended“Enforcement Decree of the Narcotics Control Act” - □ The Ministry of Food and Drug Safety (MFDS, Minister Kim G...
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(1.5) Desginated Nine substances as narcotics or precursors.pdf
2021-01-18 -
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67Key features and mechanism of action of COVID-19 vaccines [Press Release, Jan 22, 2020][Press Release, Jan 22, 2020 / unofficial translation ] Key features and mechanism of action of COVID-19 vaccines □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) provided the following clarification regarding the key features and mechanism of action of COVID-19 vaccines. ...
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(1.7) 코로나19 백신의 특징 및 작용원리(영문용)_eng1.pdf
2021-01-15 -
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66MFDS begins review of Astrazeneca’s COVID-19 vaccines [Press Release, Jan 4, 2021][Press Release, Jan 4, 2021 / unofficial translation ] MFDS begins review of Astrazeneca’s COVID-19 vaccines- MFDS aims to assess the safety and efficacy of the vaccine thoroughly and swiftly within 40 days - □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) received ...
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(1.4) 아스트라제네카 코로나19 백신 허가·심사 착수_eng_수정.pdf
2021-01-08 -
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65[Press Release, Dec 31, 2020] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)[Press Release, Dec 31, 2020 / unofficial translation ] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II) - 21 COVID-19 therapeutics and vaccines under clinical trial in Korea - □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted approval, on ...
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(12.31) 국내 개발 코로나19 백신(1·2상) 임상 승인_eng_최종.pdf
2021-01-07 -
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64[Press Release, Dec 29, 2020] MFDS begins review of Celltrion’s COVID-19 monoclonal antibody therapy[Press Release, Dec 29, 2020 / unofficial translation ] MFDS begins review of Celltrion’s COVID-19 monoclonal antibody therapy- MFDS aims to assess the safety and efficacy of the treatment thoroughly and swiftly within 40 days - □ Following Celltrion Inc.’s submission of marketin...
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(12.29) 셀트리온 코로나19 치료제 허가·심사 착수_eng4.pdf
2021-01-05 -
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63[Press Release, Dec 22, 2020 ] MFDS begins rolling reviews of Janssen’s (Johnson&Johnson’s) COVID-19 vaccine[Press Release, Dec 22, 2020 / unofficial translation ] MFDS begins rolling reviews of Janssen’s (Johnson & Johnson’s) COVID-19 vaccine □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that Janssen (Johnson & Johnson) applied for a rolling revie...
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(12.22) 식약처, 얀센社(존슨앤드존슨) 코로나19 백신 사전검토 착수(수정).pdf
2020-12-29 -
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62[Press Release, Dec 18, 202] MFDS begins rolling review of Pfizer’s COVID-19[Press Release, Dec 18, 2020 / unofficial translation ] MFDS begins rolling review of Pfizer’s COVID-19 vaccinesAstrazeneca also applied for additional rolling reviews □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that Pfizer has begun a rolling submission...
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(12.18) 식약처, 화이자社 코로나19 백신 사전검토 착수.pdf
2020-12-29 -