환자 중심 의료제품 개발의 국제 동향 비교고찰 연구 - 미국과 유럽을 중심으로

A Comparative Study of Patient-Centered Medical Product Development : Focusing on the United States and Europe

The patient-centered approach in medical product development is gaining importance, with regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) incorporating patient engagement into evaluation and approval processes. This study analyzes international trends in patient-centered medical product development by examining the regulatory initiatives, policies, and organizational structures, case studies of the FDA and EMA through a comprehensive analysis of official documents, guidelines, and legislative sources. The United States legally mandated the FDA to publish Patient-Focused Drug Development (PFDD) guidelines on methods for collecting and measuring patient experiences and perspectives. In addition, the FDA manages patient engagement through dedicated divisions and offices. In contrast, no specific law related to patient engagement or a dedicated department overseeing these activities has been identified within the EMA. While development and operational processes differ, both the FDA and EMA have actively promoted the collection and utilization of patient experience data (PED), including patient preference information (PPI), to enhance patient-centered regulatory decision-making. The findings provide insights about the global trend of patient-centered approaches that utilize PED and PPI in regulatory decision-making. To promote patient-centered medical product development, it would be beneficial to establish initiatives and frameworks in Korea’s regulatory decision-making system that align with global trends while reflecting the domestic context.