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Abbreviations ATMP: Advanced therapeutic medicinal product CHMP: Committee for medicinal products for human use COMP: Committee for orphan medicinal products DFS: Disease-free survival EFS: Event-free survival EC: European Commission EMA: European medicines agency EPAR: European public assessment report EU: European Union EUMRN: EU medicines regulatory network FEV: Forced expiratory volume ITT: Intention-to-treat population MAA: Marketing authorization application MAH: Marketing authorization holder MS: Member state ODD: Orphan drug designation OMAR: Orphan maintenance assessment report OMP: Orphan medicinal product ORR: Objective response rate OS: Overall survival pCR: Pathological complete response PFS: Progress-free survival PRAC: Pharmacovigilance Risk Assessment Committee PRIME: Priority medicines RCT: Randomized controlled trials RWD: Real world data RWE: Real world evidence SME: Small and medium sized enterprises US: United States References Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

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Archived from the original on December 28, 2019