비처방의약품 허가 제도의 국가별 비교 연구 및 고찰

Abstract

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducingexpenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individualconsumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry forqualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professionalopinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC MonographProcess. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment requiredwhen the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved withreference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of theregulatory framework and the requirements for nonprescription approval process in different countries, several ways to improveregulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.