한국, 미국, 유럽의 국제공통기술문서 Module 1 제출양식 중 의약품 표시에 관한 자료 비교 연구

Abstract

National efforts to enhance the readability and utilization of drug labeling information are ongoing, emphasizing the pivotal role of effective systems influenced by regulatory frameworks. A comparative analysis of drug labeling submissions within the administrative context of Module 1 of the Common Technical Document revealed the potential to discern disparities in managing drug labeling information across distinct nations. Consequently, this study scrutinized the structure of drug labeling submissions in Module 1 within the jurisdictions of Korea, the United States, and Europe. Significantly, the United States and Europe require data assessing the consumer’s understanding of drug labeling, subject to regulatory review. In contrast, the Korean regulatory framework overlooks audience considerations and lacks data evaluating labeling appropriateness. These differing submission practices result in significant disparities in drug labeling content and format. Regulatory specifications heavily shape drug labeling, leading to differences in the depth of oversight due to submission format disparities. While the administrative content encompassed within Module 1 of the Common Technical Document acknowledges national discrepancies, we aspire to establish a more sophisticated and consumer-centric drug-labeling system in Korea.