Health Authorities "Establish Dedicated Teams for Each COVID-19 Vaccine"

Approval Period for Items Reduced to Within 40 Days

[Asia Economy Reporter Yujin Cho] To increase the short-term supply of COVID-19 vaccines, government authorities have formed dedicated teams for batch release approval for each vaccine.

In particular, testing methods required for the evaluation of new technology-based mRNA vaccines will be established in advance before the approval application.

The Ministry of Food and Drug Safety (MFDS) announced on the 2nd that it is preparing to proceed with national batch release approval by urgently purchasing nine types of analytical equipment and securing an RNA-dedicated analysis laboratory.

The MFDS aims to shorten the existing product approval period, which takes more than 180 days, to within 40 days through pre-review and approval examination for each COVID-19 vaccine and treatment product.

Additionally, to expedite the productization of COVID-19 pharmaceuticals, the approval period for clinical trial plans has been shortened from the existing 30 days to 7 or 15 days.

For new substances, processing is to be completed within 15 days, and for drug repositioning that adds efficacy to already approved pharmaceuticals or those undergoing clinical trials, within 7 days.

The MFDS has been operating the "High-Intensity Rapid Productization Promotion Program" (GO-Rapid Program) since April last year, which includes these measures to support vaccine and treatment development.

The MFDS also established a "team review operation system" to thoroughly review clinical trials and approval applications for COVID-19 vaccines and treatments. There are teams by type such as the "Virus Vector Vaccine Team," "Nucleic Acid Vaccine Team," and "Antibody Therapeutics Team."

From 90 days before the expected product approval application, a "dedicated approval review team" composed of specialized reviewers in each field is formed to conduct pre-consultation and pre-review before the approval application.

The MFDS established the "Rapid Review Division," an organization dedicated to the rapid review of COVID-19 pharmaceuticals. To ensure expertise and transparency in the review process, an "Expert Advisory Group" composed of external experts has also been formed and is currently operating.

This content was produced with the assistance of AI translation services.