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첨단바이오의약품 신속처리제도 분석: 미국, 유럽연합, 일본, 한국을 중심으로 Analysis of Advanced Therapy Medicinal Product Expedited Processing System: Focusing on the United States, the European Union, Japan and South Korea

약학회지 2023년 67권 5호 p.302 ~ 310
이다혜, 박지혜, 윤혜수, 김승우, 김상운, 김은영,
소속 상세정보
이다혜 ( Lee Da-Hye ) 

박지혜 ( Park Jee-Hye ) 

윤혜수 ( Yoon Hye-Soo ) 

김승우 ( Kim Seung-Woo ) 

김상운 ( Kim Sang-Wun ) 

김은영 ( Kim Eun-Young ) 

Abstract


In order to address unmet medical needs, regulatory agencies in each country have an expedited processingsystem that rapidly develops and commercializes Advanced Therapy Medicinal Products. This study analyzed the expeditedprocessing systems of the United States, European Union, Japan, and South Korea by referring to the websites ofregulatory agencies and related regulations and documents. The expedited processing system is divided into approvalpathway and designation, where approval pathway is the mechanism for marketing approval, while designation is given todrugs that meet specific criteria. Among several systems, South Korea has customized examination and conditionalapproval within expedited processing clauses, the United States has Regenerative Medicine Advanced Therapy, theEuropean Union has PRIME, and Japan has Sakigake. Although there are differences in the conditions for beingdesignated as subject to expedited processing in each country, most of the other conditions stipulate similar contents. Inorder for the expedited processing system of the Advanced Regenerative Bio Act to achieve international harmony,domestic regulatory agencies must actively intervene to achieve interaction in the development process of AdvancedTherapy Medicinal Products, and multidisciplinary and multi-institutional organizations must participate together.

키워드

Advanced Therapy Medicinal Products; Expedited processing system; Expedited approval; Expedited program; Fast Track

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