[그린포스트코리아 이민선 기자] The Ministry of Food and Drug Safety will initiate a preliminary review of Janssen’s Corona 19 vaccine, which the government announced plans to introduce.
The Ministry of Food and Drug Safety (Director Kang-lip Kim) announced that Janssen (Johnson & Johnson) had applied for a preliminary review before applying for a COVID-19 vaccine.
This vaccine is one of the vaccines that the government has announced plans to introduce, and this time, we applied for a preliminary review of non-clinical and quality data. Accordingly, the’Virus Vector Vaccine Team’, an exclusive license review team, will carefully review the toxicity, pharmacological and quality data of the vaccine in advance.
Currently, the Ministry of Food and Drug Safety has formed and is operating a’license-dedicated review team’ such as a virus vector vaccine team and a nucleic acid vaccine team for rapid evaluation in preparation for domestic approval applications for Corona 19 vaccine.
Vaccine developers can submit data such as quality, non-clinical, and clinical data to the Food and Drug Administration as soon as they are prepared for preliminary review before applying for approval.
An official from the Ministry of Food and Drug Safety said, “Through this, we expect to secure time to fully review the safety and effectiveness of the vaccine, and shorten the period of review after application for permission as much as possible.” “We will do our best to supply them quickly.”
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