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

• 영문명: Comparative Analysis on Common Technical Document Module 1 Submission Form of Drug Labeling in South Korea, United States and Europe
• 발행기관: 대한약학회
• 저자명: 양진욱(Jinwook Yang) 권경희(Kyenghee Kwon)
• 간행물 정보: 『약학회지』제67권 제6호(2023년), 404~414쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2023.12.31

영문 초록

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.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Common Technical Document Package Leaflet Readability