Vaccine/treatment approval and review thoroughly and promptly… Operation of’GO-Fast Program’
Target to shorten the processing period to within 40 days through preliminary review by item and permission/examination
[서울=뉴스핌] Reporter Jeong Gyeong-hwan = The Ministry of Food and Drug Safety is fully preparing for the rapid supply of Corona 19 vaccine and treatment. The policy is to reduce the approval/examination period to within 40 days and the shipment approval period to within 20 days through the formation of a vaccine and treatment approval evaluation team, an expert consultation body, and a shipment approval team.
The Ministry of Food and Drug Safety said on the 2nd, “We are preparing to thoroughly and promptly carry out the approval and review of Corona 19 vaccines and treatments that are currently being developed at home and abroad.”
Earlier, the Ministry of Food and Drug Safety announced on the 27th that it aims to shorten the existing treatment period (usually 2-3 months or more) and treat it within 20 days for the Corona 19 vaccine.
The Ministry of Food and Drug Safety said, “For the thorough national shipment approval of the Corona 19 vaccine, which must be supplied in a short period of time, we have formed a shipping approval team for each type of vaccine.” “In particular, the test methods necessary for testing and testing of mRNA vaccines using new technology We plan to establish it in advance before applying for permission, and for this, we are making every effort to proceed with national shipment approval, such as urgently purchasing 9 types of analysis equipment and securing an analysis room dedicated to RNA.”
| Corona 19 vaccine image [사진=로이터 뉴스핌] |
Along with this, the Ministry of Food and Drug Safety has been operating a’high-intensity rapid productization promotion program’, or’GO-rapid program,’ to support the development of vaccines and treatments from April last year following the corona 19 pandemic.
This is to promote the development of domestic vaccines and treatments, to thoroughly screen vaccines and treatments developed in foreign countries, and to quickly introduce them to the country. Research and development of candidate substances, clinical approval, permission screening, technology information sharing, and international cooperation It is a program to provide differentiated support for the back.
In particular, in the case of approval of a clinical trial plan, new substances are processed within 15 days, and if an already approved drug or a drug in the clinical trial adds efficacy or effect (drug re-creation), it is processed within 7 days, compared to the previous 30 days. It is making it possible to enter quickly.
A dedicated permit review team is also being formed and operated. As the clinical trials of COVID-19 vaccines and treatments are accelerated and applications for approval become visible, a’team review operation system’ has been established to thoroughly permit and review.
The Ministry of Food and Drug Safety said, “From 90 days before the application for permission for an item is expected, it has formed a’permission-dedicated examination team’ consisting of expert examiners in each field, and conducts preliminary consultation and review before applying for permission. He said.
In August, a dedicated review organization called the’Expedited Review Division’ was also established to proactively respond to the development of a vaccine and treatment for Corona 19.
In addition, the Ministry of Food and Drug Safety has formed and is operating a’Expert Council’ that consults external experts in order to increase the expertise and transparency of corona19 vaccine and treatment approval and review.
The Ministry of Food and Drug Safety said, “We aim to shorten the existing treatment period (over 180 days) through preliminary review, approval, and review for each item for Corona 19 vaccines and treatments, and to treat them within 40 days.” We will do our best to ensure that vaccines and treatments with sex can be supplied as quickly as possible.”
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