Spring Intro 2023

03/03/2023

Timelines: UK: 30 days for initial assessment, ~14 days to respond to a GNA and final determination by day 60. In the UK there is a target of 14 days average for initial assessment for Phase I studies. COVID-19 trial applications had a target of 48 hours. EU CTR: 45 days for initial assessment, maximum 31 days added if further information is required. Final decision on trial (part 1 and 2) through portal within 5 days  total 81 days (add 50 more if e.g. ATMP). These timelines do not appear to be being met at the moment.

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MAAs have the nonclinical overview, written summaries, tabular summaries and all the primary reports. CTA applications have Investigator’s Brochures and/or IMPDs. CTA applications are not supported by primary reports in the UK and EU – Regulators are supposed to trust you not to tell them fibs!

MAKE SURE YOU KNOW WHAT YOUR DATA ARE TELLING YOU AND DON’T CONCENTRATE ON IDENTIFYING A NO OBSERVED ADVERSE EFFECT LEVEL (NOAEL) !

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