해외 주요국의 의약품 정보수집 관련 Horizon Scanning 활용 현황과 시사점

• 영문명: Horizon Scanning for Collecting Drug Information in Selected Countries and their Policy Implications in South Korea
• 발행기관: 한국사회약학회 (구.한국보건사회약료경영학회)
• 저자명: 최나혜 양동욱 김유진 서영원 손경복
• 간행물 정보: 『한국사회약학회지』제10권 제2호, 61~69쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2022.11.30

영문 초록

As technological development accelerates, regulatory authorities have to collect relevant information to address rapid and safe introduction of new drugs with advanced technology. In this study, we investigated the cases of selected high-income countries that took advantage of horizon scanning, a systematic information collection method, for their early response to new drugs and advanced technologies in health care settings. To this end, we reviewed the contents available at the website of the relevant institution, as well as the literature such as white reports and journal articles. The International Coalition of Medicine Regulatory Authorities (ICMRA) was engaged in activities to prevent overlapping work in each country and to harmonize of regulatory procedures. ICMRA's Horizon Scanning Project suggested specific methodologies through an analysis of global best practices, identified regulatory science areas to address emerging technologies, and provided policy options to promote market access of new medicines. The PharmaScan database, in which manufacturers directly input information, was operated and used for horizon scanning in the UK. Considering the implications obtained through case review of each country, horizon scanning will contribute to improving regulatory approval process and to enhancing early market access of new drugs in Korea.

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키워드

horizon scanning regulatory authority collecting information advanced therapy medicinal products