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Types Of Procedure(EU,USA)

EMA Pharmaceuticals

✿Centralized Procedure (CP)
✿Mutual Recognition Procedure (MRP)
✿Decentralized Procedure (DCP)
✿National Procedure (NP)
✿PUMA
✿Biosimilars
✿Generic Appln

NB MD/IVD

✿Various Conformity Assessment Pathways (CAPs) for various Risk Classes based on MDR/IVDR




FDA MD/IVD

✿Premarket Notification 510(k)
✿ 510 (k) Excemption
✿ IDE and PMA





FDA Pharmaceuticals

✿505 (b)(1) NDA/NADA
✿ 505 (b)(2) NDA
✿ANDA
✿BLA