CRED 8 Presentations

01/07/2024

Preparing for an Oral Explanation (OE) • Applicant or Agency can request an OE after LoOI – best done Face-to-Face: • CHMP determines need to consult working parties or Scientific Advisory Group • Usually happens Tuesday or Wednesday (start of CHMP meeting) • May be cancelled last minute if written responses considered satisfactory • Send in advance: Responses, draft SmPC/RMP/post-approval commitments, presentation • Generally short (<60 minutes): Company briefly presents positions on the major pending issues with an opportunity for questions and answers • For clinical/medical questions: may be helpful to have a well-prepped KOL/expert • Make sure a senior team on site with decision making power prepared to activate fall-back positions as part of risk mitigation strategy • Prepare and rehearse extensively! • Afterwards CHMP will vote: positive/negative trend determined

Abbreviations: LoOI = list of outstanding issues, KOL = key opinion leader, T/C = teleconference

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants/marketing

The Organisation for Professionals in Regulatory Affairs

authorisation-holders-oral-explanations-european-medicines-agency_en.pdf

23

What to Expect during CHMP Week

• Final discussion of dossier before voting • CHMP likely to have ad-hoc questions that need to be turned around rapidly to finalise the opinion and EPAR • EMA Product Lead may send requests for update of RMP, product information and post-approval commitments • Keep in close contact; monitor emails closely • May help to be co-located in EU timezone • Ensure team available with decision making power • At the end of the week, you will receive • A Day 210 letter (Opinion) and product information annexes, MA number and annex A, final assessment report and linguistic review timetable • All need to be reviewed/checked in case of any errors

NOTE: Consider that if CAT involved then you need to consider two committee meetings i.e. CAT meeting and CHMP where formal adoption of opinion occurs.

The Organisation for Professionals in Regulatory Affairs

24