Related by context. Frequent words. (Click for all words.) 55 Marketing Authorization Application 53 Orphan Drug status 53 Marketing Authorization 52 Orphan Drug Status 52 Mutual Recognition Procedure 52 orphan designation 52 FIRAZYR 50 INDs 50 Orphan Drug Designation 50 Loramyc ® 50 biogeneric 49 Orphan Drug designation 49 Scientific Advice 49 Mutual Recognition 48 Cladribine Tablets 48 Priority Review 48 Biologics License Application 47 eCTD 47 Rhucin ® 46 biosimilars 46 Capital Requirements Directive 46 European Medicines Evaluation 45 ATryn ® 45 Structural Funds 45 pediatric exclusivity 45 European Medicines Agency 45 Replagal 45 ELAPRASE 45 Ceftobiprole 45 Iceland Liechtenstein 45 BENLYSTA 45 supplemental Biologics License Application 44 BLA submission 44 SPAs 44 Swissmedic 43 CE Marking 43 GEM #S 43 MONOVISC 42 Fast Track Designation 42 alogliptin 42 taliglucerase alfa 42 Mitigation Strategy REMS 42 cervical cancer vaccine Cervarix 42 OJEU 42 EFPIA 42 Economic Area EEA 42 regulatory 42 depositaries 42 Competent Authority 42 UCITS 42 NDAs 41 CHMP opinion 41 ECHA 41 EU Directives 41 QAB# 41 IND submission 41 Bioxel 40 biogenerics 40 Czech Republic Estonia 40 pharmacoeconomic 40 India DCGI 40 Flutiform 40 #/#/EC [002] 40 Notified Body 40 Regulatory 40 FP6 40 Mifid 39 Seventh Framework Programme 39 pharmacovigilance 39 Directive #/#/EC [004] 39 GMPs 39 USFDA 39 ANDA 39 Baltic Sea Region 39 Harmonisation 39 DCGI 39 Hatch Waxman 39 sBLA 39 Testim 38 IP/#/# [003] 38 CRAs 38 Fast Track designation 38 derogations 38 EEA 38 exclusivity periods 38 regulatory frameworks 38 clinical trials 38 Investigational Device Exemption 38 EFTA countries 38 TRIPS Agreement 38 Cohesion Fund 37 European Union 37 OHIM 37 PDUFA 37 CCPs 37 CHMP 37 Water Framework Directive 37 LEP 37 SEAP 37 EPHA 37 exemptive relief