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Descriptions - Assessment of the clinical data package (CDP) for acceptability

Assessment of the clinical data package in the new region: Original CDP including foreign clinical data - question 1 meets regulatory requirements? Yes, question 2, extrapolation of foreign data appropriate? Yes, further clinical study(ies) needed for acceptability by the new region, question 3 - no further clinical study needed - acceptability in the new region? Question 4: clinical data package for the new region.

Assessment of the clinical data package in the new region: Original CDP including foreign clinical data - question 1 meets regulatory requirements? Yes, question 2, extrapolation of foreign data appropriate? No, further clinical study(ies) needed for acceptability by the new region, question 3 - study(ies) needed to bridge (bridging studies) - acceptability in the new region? Question 4: clinical data package for the new region.

Assessment of the clinical data package in the new region: Original CDP including foreign clinical data - question 1 meets regulatory requirements? No, question 2, extrapolation of foreign data appropriate? Yes, further clinical study(ies) needed for acceptability by the new region, question 3 - Additional clinical study(ies) to meet regulatory requirements (additional clinical study(ies) - acceptability in the new region? Question 4: clinical data package for the new region.

Assessment of the clinical data package in the new region: Original CDP including foreign clinical data - question 1 meets regulatory requirements? No, question 2, extrapolation of foreign data appropriate? No, further clinical study(ies) needed for acceptability by the new region, question 3 - Clinical study(ies) to meet regulatory requirements and to bridge (additional clinical study(ies) (bridging studies) - acceptability in the new region? Question 4: clinical data package for the new region.