In the case of a new drug developed by a first-in-class pharmaceutical company, a priority review request can be made to the rapid review division of the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety recently prepared detailed procedures, such as the method of requesting designation from the Minister of Health and Welfare, when prioritizing new drugs developed by innovative pharmaceutical companies. According to Article 35, Paragraph 4 of the Pharmaceutical Affairs Act, which was revised in July 2021, 'drugs for which the Minister of Health and Welfare has requested designation among new drugs developed by innovative pharmaceutical companies pursuant to Article 2, Subparagraph 3 of the Special Ac