Presentation and Analysis of the EFPIA Questionnaire 06/08 on the - PowerPoint PPT Presentation

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Presentation and Analysis of the EFPIA Questionnaire 06/08 on the Centralised Procedure New Applications

Presentation and Analysis of the EFPIA Questionnaire 06/08 on the Centralised Procedure New Applications ��
Responses ��
Scientific Advice (questions 1 to 8) � ��
Accelerated Assessment (questions 9 – 12) � 16 requested accelerated assessment 25% [05/06 = 33%] � 6 granted accelerated assessment [05/06 = 5%] � 2 approved under accelerated assessment (3%) [05/06 = 5%] (4 converted to normal timetable) � US/FDA “priority review” granted to 16 of the cohort Comments: (free text) � No justification for refusal � Company “discouraged” to apply x 3
Conditional Approval/Exceptional Circumstances (questions 13-14) � 6/64 approved “on condition” � Only 2 applied for conditional approval � 3/64 approved “under exceptional circumstances” – only 2 applied
Validation Q 16 � No major issues encountered during validation for most applications � Helpful EMEA guidance during validation 06/08 scale 1-10 05/06 7.1 7.8
Initial Assessment Report (Q17/18) Rapporteur Q17 Co-rapporteur Q18
Initial Assessment Reports Q17 ��
Initial Assessment Reports Q18 ��
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