첨단바이오의약품 신속처리제도 분석

Analysis of Advanced Therapy Medicinal Product Expedited Processing System: Focusing on the United States, the European Union, Japan and South Korea

In order to address unmet medical needs, regulatory agencies in each country have an expedited processing system that rapidly develops and commercializes Advanced Therapy Medicinal Products. This study analyzed the expedited processing systems of the United States, European Union, Japan, and South Korea by referring to the websites of regulatory agencies and related regulations and documents. The expedited processing system is divided into approval pathway and designation, where approval pathway is the mechanism for marketing approval, while designation is given to drugs that meet specific criteria. Among several systems, South Korea has customized examination and conditional approval within expedited processing clauses, the United States has Regenerative Medicine Advanced Therapy, the European Union has PRIME, and Japan has Sakigake. Although there are differences in the conditions for being designated as subject to expedited processing in each country, most of the other conditions stipulate similar contents. In order 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 Advanced Therapy Medicinal Products, and multidisciplinary and multi-institutional organizations must participate together.