The Ministry of Food and Drug Safety organized a working group in charge of approving the shipment of the Corona 19 vaccine … “Provide as quickly as possible”

[서울=뉴스핌] Reporter Jeong Gyeong-hwan = The Ministry of Food and Pharmaceutical Safety is fully preparing for the rapid supply of Corona 19 vaccine and treatment. The policy is to reduce the approval / review period to 40 days and the shipment approval period to 20 days by forming 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 day 2: “We are preparing to carry out a comprehensive and rapid 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 full approval of the domestic shipment of Corona 19 vaccine, which must be delivered in a short period of time, we have formed a shipment approval team for each type of vaccine.” We plan to establish it in advance before applying for the permit, and for this, we are doing everything possible to proceed with the approval of the national shipment, such as urgently buying 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 production promotion program’ or ‘rapid GO program’ to support the development of vaccines and treatments since April last year after the pandemic. crown 19.

This is to promote the development of vaccines and domestic treatments, to thoroughly evaluate vaccines and treatments developed in foreign countries, and to introduce them quickly into the country. Research and development of candidate substances, clinical approval, detection of permits, exchange of technological information and international cooperation It is a program to provide differentiated support to 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 (recreation of the drug), it is processed within 7 days, compared to the previous 30 days. It allows you to enter quickly.

A dedicated permit review team is also being formed and operated. As clinical trials of COVID-19 vaccines and treatments accelerate and approval requests become visible, a ‘team review operating system’ has been established to enable and comprehensive review.

The Ministry of Food and Drug Safety said: “Since 90 days before a permit application for an item is expected, it has formed a ‘dedicated permit examination team’ consisting of expert examiners in each field, leading to conduct preliminary inquiries and reviews before applying for permission, he said.

In August, a specialized 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 “ Council of Experts ” that consults with external experts to increase the expertise and transparency of corona19 vaccine approval and review and treatment.

The Ministry of Food and Drug Safety said: “Our goal is to shorten the existing treatment period (more than 180 days) by preliminary review, approval and review for each element of Corona 19 vaccines and treatments, and treat them within the 40 days “. We will do our best to ensure that vaccines and sexual intercourse treatments can be provided as soon as possible. “

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