국가별 전자적 형태의 의약품 첨부문서(e-라벨) 제공 현황 분석: 한국, 미국, 유럽, 일본, 싱가포르를 중심으로

Abstract

Recent amendments to the Pharmaceutical Affairs Act permit certain prescription drugs in South Korea to provide packaging leaflets electronically, referred to as e-labels. As this system has been adopted internationally, variances in information delivery mechanisms necessitate a review to guarantee both readability and utility. This study compares elabel regulations in Korea, Japan, the U.S., Europe, and Singapore. In Korea, the Act does not distinguish between the targets of the drug package insert and allows the e-labels to replace the paper package insert. Japan similarly provides elabels based on the law, but only for prescription drug package inserts for HCPs. Singapore is running a pilot based on guidelines for e-labeling issued by the regulator. It started with the package inserts for HCPs for prescription medicines but has recently expanded its e-labeling to include non-prescription medicines. In Europe, electronically provided medicinal product information is known as ePI, and a pilot project is underway to establish core principles and utilization plans for providing it. In particular, the e-labels will not replace the paper inserts and will ensure maximum accessibility and use of the information by consumers. In the U.S., the proposal to make prescribing information for HCPs available only electronically failed to reach a consensus on the public health benefits, so drug information is still provided in the same way. As e-labeling is a global trend, Korea will adopt it, but institutional mechanisms are needed to reduce drug information blind spots that inevitably occur in the process. We hope that the e-labeling system will be established to ensure consumers’ right to know, reduce drug information blind spots, and ultimately contribute to improving public health.