첨단바이오의약품 신속처리제도 분석: 미국, 유럽연합, 일본, 한국을 중심으로

초록

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.

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