CRED 8 Presentations

01/07/2024

Centralised Procedure defined but …

 Reviews of 2 years and longer for 17 products ● Zeftera June 2007 – June 2010

– GCP issues identified by FDA after Positive Opinion with post-opinion GCP inspections and multiple lists of questions and Oral Explanation – Re-examination Procedure unsuccessful ● Eladynos November 2015 – July 2018 – Three “Day 180” Lists of Outstanding Issues with 2 Oral Explanations, total >20 months clock stops –Re-examination Procedure unsuccessful – Company did additional Phase 3 studies, resubmitted in 2021 and was approved 2022 ● Alpheon December 2003 – June 2006 – Submission Dec ‘03 procedure start June ‘04, 14-month clockstop at D120, extensive interactions between CHMP and BWP, two Oral Explanations

The Organisation for Professionals in Regulatory Affairs

15

Managing Internal Expectations – Accelerated Review

 Rare in CP: can revert to standard review clock ● Applicant unable to respond during the shortened clock stop or Major Objections that are not resolvable under accelerated assessment ● 2012-2016: 80 requests, 40 accepted, 20 reverted to standard clock  FDA RTOR setting new standards that will be hard to follow ● And that is a good thing … Respond within 24-48 hours; sometimes same day. ● Approval of NME in 2-3 months or supplement in 2-3 weeks with lots of submissions and interactions as early as topline study results are available

The Organisation for Professionals in Regulatory Affairs

16