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The Ministry of Food and Drug Safety announced on day 2 that it has formed a ‘shipping approval working group’ for each type of vaccine to supply large quantities of a new vaccine against coronavirus infection (Corona 19) in a short time frame.
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| ▲ The Ministry of Food and Drug Safety has organized a shipment approval team for each type of Corona 19 vaccine (photo source = Yonhap News) |
The Ministry of Food and Drug Safety plans to establish in advance the necessary test methods for testing and analysis, particularly for mRNA vaccines using new technologies, before applying for approval. To this end, we are preparing to proceed with the approval of national shipment, such as the rush purchase of 9 types of analysis equipment and securing a dedicated RNA analysis room.
The Ministry of Food and Drug Safety aims to shorten the approval period for existing products that took more than 180 days to a period of 40 days through a preliminary review and approval review for each item for Corona vaccines and treatments. 19.
Previously, the Ministry of Food and Drug Safety has been operating a “high intensity rapid production promotion program” (GO-rapid program) since April last year to support the development of vaccines and treatments.
The program contains the content to shorten the approval period of the clinical trial plan from 30 days to 7 or 15 days for the rapid commercialization of COVID-19 drugs. The new substances were processed in 15 days and the recreation of drugs that adds efficacy to drugs already approved or in clinical trials was processed in 7 days.
Composition by type of operational vaccine review team
The Ministry of Food and Drug Safety has also established a ‘team review operating system’ to thoroughly review applications for approval and clinical trials for COVID-19 vaccines and treatments.
By type, there are ‘Vector Virus Vaccination Kit’, ‘Nucleic Acid Vaccination Kit’ and ‘Antibody Treatment Kit’.
From 90 days before the product permit application is expected, a ‘dedicated license review team’ is formed consisting of expert reviewers in each field to conduct preliminary inquiries and reviews before applying for the permit.
The Ministry of Food and Drug Safety has established the ‘Expedited Review Division’, an organization dedicated to the rapid review of Corona 19 medicines. In addition, the “Expert Council” has been formed and operated to consult external experts on the experience and transparency of the exam.
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