의약품 첨부문서의 시각적 가독성과 이해도 확보를 위한 국가별 제도 비교: 한국, 유럽연합, 미국, 캐나다, 호주를 중심으로

초록

Although package inserts are essential for the safe and effective use of medicines, they have often been criticized for poor legibility and readability, especially in South Korea. This study compares regulatory frameworks for package inserts for consumers in South Korea, the European Union, the United States, Canada, and Australia. We reviewed national laws, regulations, and guidelines, focusing on mandatory requirements and recommendations for formatting standards, plain language, content structure, and verification procedures. We found that, unlike South Korea, the other four jurisdictions use a two-tiered system that separates information for healthcare professionals and consumers, and they provide standardized templates, detailed formatting criteria, and verification mechanisms for package inserts for consumers. In contrast, South Korea does not provide separate package inserts for consumers and regulates only the minimum font size and line spacing, resulting in limited legibility standards. For readability, South Korea offers only a list of plain-language terms and lacks verification procedures, such as pre-market evaluation, to ensure package inserts are understandable. To improve the safe and effective use of medicines, the regulatory framework should specify detailed legibility criteria, introduce comprehension-enhancing measures through a stepwise approach tailored to the Korean context, and establish a dedicated unit to conduct integrated pre- and post-market evaluations.

키워드