일반의약품 외부 포장의 국가별 표시제도 비교분석: 레지빌리티(legibility) 요소를 중심으로

Abstract

Labeling of non-prescription medicines should be legible and clear, and should be written with the consumer'sreadability in mind so that the consumer can take proper action. In this study, we compared and analyzed the regulatorylabeling system and factors applied in the non-prescription drugs’ outer packaging, focusing on the legibility as one of theelements of readability. Although the domestic regulations have been improved to a considerable extent as a result of variousstudies to improve the system until recently, it is still not enough in terms of the detailed standards as compared with theoverseas guidelines. In particular, the United States provides a detailed guide by applying the standard format design calledDrug Facts. In Europe, the labeling guidelines are not concrete, but basically the notion of readability implies that the consumeris required to make the information easy to read and understand. Europe also has a pre-approval system of packagingand attached documents in the pre-market stage to ensure that consumers are provided with readable drug information. However, there may be a gap between regulation and the real products so it is necessary to design delicate regulations sothat it can be applied to products well. Also, even if a consistent format is presented, it will be possible to achieve theimprovement only when education on how to read and use the labeling of non-prescription drugs is supported.