CRED 8 Presentations

01/07/2024

Similar special designations • Working in EMA clock environment limits the ability to use them in EU • Fast Track benefits limited since BTD has become available • Rolling Review PDUFA clock starts at submission of the final component Managing Internal Expectations – Designations

Cox et al. Clin Transl Scie 2020;13(3):451-461

The Organisation for Professionals in Regulatory Affairs

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PRIority MEdicines

Launched March 2016 to provide early and enhanced scientific and regulatory support to medicines that have the potential to significantly address patients’ unmet medical needs. ● MAA Clock-stop reductions and more for SMEs ● ATMPs had shorter assessment and clock-stop duration ● More likely to be granted and retain accelerated assessment ● Correlation between compliance with scientific advice, maintenance of accelerated assessment and approval

The Organisation for Professionals in Regulatory Affairs

2023 EMA Annual Report, PRIME analysis rolling 5 years experience

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