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. 2019 Aug 3;20(15):3801. doi: 10.3390/ijms20153801
IVD in vitro diagnostics
FDA Food and Drug Administration
NDA new drug applications
BLA biologics license applications
EMA European Medicines Agency
ATMP advanced-therapy medicinal products
CHMP Committee for Medicinal Products for Human Use
CAT Committee for Advanced Therapies
PMDA Pharmaceuticals and Medical Devices Agency
MHLW Ministry of Health, Labour and Welfare
PDUFA Prescription Drug User Fee Act
RMAT regenerative medicine advanced therapy
PRIME priority medicines