Corona 19 vaccine item approval is completed within 40 days… Composition of task force for each vaccine

Significantly reduced from the existing 180 days… The Ministry of Food and Drug Safety is preparing for national shipment approval

(Seoul = Yonhap News) Reporter Seung-Hyun Gye = The Ministry of Food and Drug Safety announced on the 2nd that it has formed a shipping approval task force for each type of vaccine in order to supply a new coronavirus infection (Corona 19) vaccine in large quantities in a short period of time.

In particular, test methods necessary for testing and testing of mRNA vaccines using new technology will be established in advance before application for approval.

To this end, it is preparing to proceed with national shipment approval, such as urgently purchasing 9 types of analysis equipment and securing an analysis room dedicated to RNA.

The Ministry of Food and Drug Safety aims to shorten the approval period for existing products that took more than 180 days to within 40 days through preliminary review and approval review for each item for Corona 19 vaccines and treatments.

In addition, the Ministry of Food and Drug Safety has shortened the approval period for the clinical trial plan from 30 days to 7 or 15 days for the rapid commercialization of Corona 19 drugs.

New substances were processed within 15 days, and drug re-creation that adds efficacy to drugs already approved or in clinical trials was processed within 7 days.

The Ministry of Food and Drug Safety has been operating a’high-intensity rapid commercialization promotion program’ (GO-rapid program) that includes this content since April last year. To support the development of vaccines and treatments.