법무법인(유한) 율촌 | Yulchon LLC

On April 29, 2022, on behalf of PCL Inc. (the “Company”), Yulchon obtained from the Ministry of Food and Drug Safety (the “Ministry”) a marketing approval for a COVID-19 self-test kit that utilizes the testing individual’s saliva (the “Product”).  It is the first such COVID-19 test kit to be approved for use by the general public in Korea.  Prior to the Ministry’s approval for the Product, all COVID-19 test kits available to Korean consumers required a nasal pharyngeal swab.  Because of the difficulty in taking the required swab properly, young children and the elderly often found the kits difficult and painful to use while the tests sometime resulted in false negatives.  By contrast, the use of the Product only requires the testing individual to discharge saliva onto a funnel.

Yulchon advised the Company at all stages of the review leading to the marketing approval, including (i) clinical trial planning and execution, (ii) reviewing documents required for the approval application, and (iii) communications with the Ministry.  Given the innovative and cutting-edge nature of the Product, from the outset, the clinical trial called for precise planning and execution that would demonstrate the Product’s effectiveness and stability.  Through seamless collaboration among Healthcare Team members, including former Ministry officials experienced in reviewing marketing approval applications, Yulchon succeeded in securing the approval for the Product only six weeks after commencing work on the project.