미국과 EU의 의약품 신속 개발 및 허가 프로그램의 동향과 쟁점

• Published in: Yaghag-hoi-ji Vol. 61; no. 3; pp. 147 - 157
• Main Author: 박실비아(Sylvia Park)
• Format: Journal Article
• Language: Korean
• Published: The Pharmaceutical Society Of Korea 30.06.2017; 대한약학회
• Subjects: 약학; Access; Innovation; Drug Approval; Safety; Expedited Program
• ISSN: 0377-9556; 2383-9457

This study investigated the expedited drug development and approval programs of the US and EU, programswhich intend to foster innovation and early access to new medicines addressing unmet health needs. I categorized the expeditedprograms into three types based on their distinctive features: shortening review time to advance the release date;approving drug based on the surrogate outcome imposing the responsibility of post-market confirmatory trials on the company;providing intensive guidance and close interaction with the company for successful development of new drug. Although those expedited programs have reduced drug development time and contributed to early access to medicines ofpatients, it is uncertain whether they have also facilitated innovation. Approvals based on the surrogate outcome raise concernsover insufficient evidence and safety issues. Studies have different results on whether safety-related warnings orwithdrawals have increased after the introduction of expedited programs. Expedited programs have been criticized withregard to the post-market study obligation, obligation which is often neither fulfilled well nor supervised rigorously. Onlyimplementing expedited program does not assure innovative development of medicines. Achievement of the goals willdepend on the details of program-relevance of qualifying criteria, thorough supervision of confirmatory studies, transparencyin evidence development. KCI Citation Count: 2