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Table 2 Days to approval for countries under the VHP system and transition from VHP to CTIS (Bari-SolidAct), and for an initial application under CTIS (AXL-SolidAct and MOSAIC)

From: Experiences and challenges with the new European Clinical Trials Regulation

Country

Bari-SolidAct VHP

Bari-SolidAct Transition

AXL-SolidAct Initial CTIS

MOSAIC Initial CTIS

Austria

253

71

-

-

Belgium

168

48

77

41

Czechia

182

51

84

-

France

83

43

78

41

Germany

211

48

-

-

Greece

92

43

79

-

Hungary

120

48

-

-

Ireland

174

51

98

86

Italy

110

48

-

16

Luxembourg

217

56

80

-

The Netherlands

-

-

-

56

Norway

91

43

80

82

Portugal

184

43

-

51

Slovakia

141

44

83

-

Spain

148

44

79

42