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KMID : 0370220230670050302
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Yakhak Hoeji
2023 Volume.67 No. 5 p.302 ~ p.310
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Analysis of Advanced Therapy Medicinal Product Expedited Processing System: Focusing on the United States, the European Union, Japan and South Korea
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Lee Da-Hye
Park Jee-Hye
Yoon Hye-Soo
Kim Seung-Woo
Kim Sang-Wun
Kim Eun-Young
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Abstract
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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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KEYWORD
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Advanced Therapy Medicinal Products, Expedited processing system, Expedited approval, Expedited program, Fast Track
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