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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