Total 151Articles, Present Page 7/16
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91Pfizer COVID-19 Vaccine Comirnaty Lot Release Approved for 250,000 People [Press Release, March 28, 2021][Press Release March 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 was swiftl...
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(3.28) Pfizer COVID-19 Vaccine Comirnaty Lot Release Approved for 250,000 People.pdf
2021-03-30 -
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90Mentoring Program for Mutual Growth of Testing and Inspection Laboratories [Press Release for Reference, March 24, 2021][Press Release for Reference, March 24, 2021 / Unofficial Translation] The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) initiated the “Testing and Inspection Laboratory Mentoring” program, which will be operated from March to October 2021. 58 private testing and inspect...
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(3.24) Mentoring Program for Mutual Growth of Testing and Inspection Laboratories.pdf
2021-03-25 -
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89Advisory Committee Meeting Outcomes on Candidate COVID-19 Treatment Napabeltan [Press Release, March 17, 2021][Press Release, March 17, 2021 / Unofficial Translation] □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) describes as follows the marketing approval process of ChongKunDang’s Napabeltan, which was repurposed for COVID-19 treatment efficacy and effect. 1. Drug Repurp...
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(3.17) Advisory Committee Meeting Outcomes on Candidate COVID-19 Treatment Napabeltan.pdf
2021-03-23 -
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88Quality Management Requirements for Exported Combination Products Explained [Press Release for Reference, March 18, 2021][Press Release for Reference, March 18, 2021 / Unofficial Translation] The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has published “Guidance on Overseas Good Manufacturing Practice (GMP) Requirements for Combination Products”, which domestic combination product man...
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(3.22) Quality Management Requirements for Exported Combination Products Explained.pdf
2021-03-22 -
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87MFDS Grants Marketing Authorization for Pfizer Korea COVID-19 Vaccine [Press Release, Mar. 5, 2021][Press Release, Mar. 5, 2021 / Unofficial Translation] On March 5, at the Final Evaluation Committee meeting involving internal and external experts, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) granted marketing authorization to Pfizer Korea for its COVID-19 vaccine, COMIRNA...
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(3.5) MFDS Grants Marketing Authorization for Pfizer Korea COVID-19 Vaccine.pdf
2021-03-19 -
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86Intensive Campaign on Eradication of Illegal Distribution of Pharmaceuticals [Press Release, Mar. 2, 2021][Press Release, Mar. 2, 2021 / Unofficial Translation] The MFDS has designated the period of March 1 through 31, 2021, as the "Intensive Campaign Week for Eradication of Illegal Distribution of Pharmaceuticals" as part of a crackdown on unlawful conduct such as illegal online advertisement and sale...
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(3.2) Intensive Campaign on Eradication of Illegal Distribution of Pharmaceuticals.pdf
2021-03-08 -
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85MFDS Appoints Pharmaceutical GMP Inspectors [Press Release, Mar. 3, 2021][Press Release, Mar. 3, 2021 / Unofficial Translation] The Ministry of Food and Drug Safety has appointed 62 Good Manufacturing Practice (GMP) inspectors who are responsible for ensuring conformity with the pharmaceutical GMP standard by assessing production and quality control of pharmaceuticals.
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(3.3) MFDS Appoints Pharmaceutical GMP Inspectors.pdf
2021-03-05 -
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84MFDS Begins Review of Janssen Korea’s COVID-19 Vaccine [Press Release Feb. 27, 2021][Press Release Feb. 27, 2021 / unofficial translation] The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that on February 27, Janssen Korea (Johnson & Johnson) filed marketing authorization application for its COVID-19 vaccine (Ad26.COV2S).
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(2.27) MFDS Begins Review of the Janssen COVID-19 Vaccine.pdf
2021-03-04 -
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83The CPAC Meeting Outcome Regarding Pfizer’s COVID-19 Vaccine [Press Release, Feb. 26, 2021][Press Release, Feb. 26, 2021 / unofficialtranslation] On February 25, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) held the Central Pharmaceutical Advisory Committee (CPAC) meeting at the headquarter in Osong, Chungbuk province, regarding safety and efficacy of COMIRN...
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(2.26) CPAC Meeting Outcome Regarding Pfizes COVID-19 Vaccine.pdf
2021-03-04 -
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82MFDS Hosts the 18th Forum for the Harmonization of Herbal Medicines (FHH) [Press Release, Feb. 24, 2021][Press Release, Feb. 24, 2021 / UnofficialTranslation] On February 25 and 26, the Ministry of Food and Drug Safety hosted closed video conference of the 18th Forum for the Harmonization of Herbal Medicines (FHH) and the 8the FHH International Symposium for discussions on latest regulations on h...
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(2.24) MFDS Hosts the 18th FHH.pdf
2021-03-02 -