Module 1 2021

30/06/2021

Conditional Approval Strategic Choice

 Extensive Studies/data may not be required in case of: • Serious debilitating/ life-threatening diseases; • Orphans; • Incomplete non-clinical and/or quality data only in emergency situations  Requirements: • Positive benefit/risk balance; • Unmet medical need; • Possibility to provide comprehensive data; • Benefit to immediate availability on the market outweighs the risks of placing on market without comprehensive studies;

The Organisation for Professionals in Regulatory Affairs

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Conditional Approval Strategic Choice

 MA subject to specific obligations (to provide comprehensive data) • Valid for 1 year on a renewable basis  Strategic Choice instead of way-out if too many questions can not yet be answered ! ● Request at pre-submission meeting

The Organisation for Professionals in Regulatory Affairs

32

16