한국, 미국, 유럽의 코로나19 백신 및 치료제 허가·승인 현황 비교

Abstract

As demand for COVID-19 vaccines and treatments has soared, each country has applied appropriate approval/authorization system according to circumstances, such as emergency use authorization, conditional marketing approval, or other rapid procedures to introduce COVID-19 related items quickly. This study compared and analyzed the approval/authorization status of COVID-19 vaccines and treatments in Korea, the United States, and Europe. There were differences in the number and types of approved vaccines and treatments and also in the approval procedures used across countries. The United States adopted the emergency use authorization system, and Europe utilized the conditional marketing authorisation system, while Korea mainly applied conditional approval for vaccines and emergency use authorization for treatments. After initial approval in the US, Europe, most vaccines and treatments were introduced with delay in Korea. For instance, the average of Drug lag time for vaccines was about two months(61.5days). In the case of treatments, the difference between Drug lag time among items was relatively large. Considering that Korea's review period for drug approval is similar to that of the United States or Europe, it is necessary to proceed more quickly with approval applications and emergency authorization reviews in the event of other public health emergencies in the future.