CRED 8 Presentations

01/07/2024

What will the Assessment Reports look like?

• Questions grouped into major objections or other concerns across topic areas • MAJOR Objections: Considered to potentially impact approvability • OTHER Objections: Require scientific resolution (can be promoted to Major) • Day 80: (Co-)Rapporteurs send their Assessment Reports to: • The CHMP (or CAT), CHMP Coordinators, and CHMP members and EMA (full assessment teams) • The Applicant for information only (no responses expected…but a good time to start!!!) • PRAC report received separately (Day 94); focusses on RMP, pharmacovigilance plan and risk minimisation measures • Questions from QRD group (labelling, mock-ups etc) usually not received until Day 120 • Day 120: Consolidated List of Questions including CHMP, PRAC, QRD and product information comments • Sent to Applicant for response – THIS MEANS YOU!

The Organisation for Professionals in Regulatory Affairs

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Preliminary Assessment Reports Preliminary assessment reports (pARs) are sent to Company for information only

Day 94: Additional pAR

PRAC Rapporteur AR (RMP) Questions

Rapporteur AR Questions

Co- rapporteur AR Questions

• First indication of approvability of dossier – find out what the assessors are thinking • Current opinions of (co)Rapporteur assessment team only with preliminary conclusions • Questions not yet consolidated; not yet discussed with rest of CAT/CHMP • Ordered into subject (clinical, non-clinical, quality etc.) and category (next slide) • Expect statements like “Your product is not approvable since "major objections" have been identified, which preclude a recommendation for marketing authorisation at the present time” • This is normal…don’t panic! • If you want a short clock-stop…now is the time to start preparing responses

The Organisation for Professionals in Regulatory Affairs

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