Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Latest COVID-19 News

MFDS Begins Rolling Review of Sputnik V COVID-19 Vaccine [Press Release, April 29, 2021]
  • Registration Date 2021-05-03
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[Press Release, April 29, 2021 / Unofficial Translation]

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that Huons Co., Ltd. filed for rolling review of Russia’s Sputnik V COVID-19 vaccine on April 29 prior to submitting an application for marketing authorization.

○ Since Sputnik V is not included in the Korean government’s COVID-19 vaccination program, Huons has filed for rolling review of the non-clinical data (toxicity and efficacy tests) in accordance with Pharmaceutical Affairs Act.

○ The MFDS will rigorously review the safety and efficacy of the vaccine, based on the submitted non-clinical data.

○ Sputnik V is a viral vector vaccine which has been authorized in 61 countries including Russia, but not in the U.S. and the E.U.
- The vaccine is currently under the European Medicines Agency (EMA)’s rolling review and the WHO Emergency Use Listing (EUL) evaluation.
* The EMA’s rolling review: since March 4, 2021 The WHO EUL evaluation: since October 2020

□ The MFDS will spare no effort for a timely provision of safe and effective vaccines.
Attached File
  • (4.29) MFDS Begins Roling Review of Sputnik V COVID-19 Vaccine.pdf Download preview

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