CRED 8 Presentations

01/07/2024

 PRIME (PRIority MEdicines) and similar initiatives

The Organisation for Professionals in Regulatory Affairs 53

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Accelerated assessment

• For products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation − What are the unmet needs? − How the product will address these? − What evidence supports? • Request to be submitted and agreed in advance of submitting the MA application • In accelerated assessment maximum ‘active’ time reduced from 210 to 150 days  > May revert back to standard timetable at any time during assessment!

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The Organisation for Professionals in Regulatory Affairs

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