Fig. 1. Expedited Processing System of FDA, EMA, PMDA, MFDS.
Expedited Processing System can be divided into Approval Pathway and Designation, and arrows of different colors for each country indicate what is possible for both ATMP and Drug and what is possible only for ATMP. ATMP: Advanced Therapy Medicinal Product, ATMP (with Drug): General medicines including ATMP, ATMP (except Drug): ATMP only