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Significantly reduced from the existing 180 days … The Ministry of Food and Pharmaceutical Safety is preparing for the approval of the national shipment
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 a new vaccine against coronavirus infection (Corona 19) in large quantities in a short period of time. .
In particular, the test methods required to test and test mRNA vaccines using new technology will be established in advance prior to application for approval.
To this end, it is preparing to proceed with the approval of the national shipment, such as the urgent 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.
In addition, the Ministry of Food and Drug Safety has shortened the approval period of the clinical trial plan from 30 days to 7 or 15 days for the rapid commercialization of Corona 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.
The Ministry of Food and Drug Safety has been operating a ‘high intensity rapid marketing promotion program’ (GO-rapid program) that includes this content since April last year.
Support the development of vaccines and treatments.
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 prior to the expected date for the product permit application, the “Permit Deliberation Team” is formed, composed of expert reviewers in each field to carry out a preliminary consultation and review 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 drugs.
In addition, the “Expert Council” has been formed and operated to consult external experts on the experience and transparency of the examination.
/ yunhap news
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