CRED 8 Presentations

01/07/2024

Accelerated Timeline – “150” day Assessment Example for ATMP Months 1 2 3 4 5 6 7 8 9 10111213141516

Linguistic review and

Assessment phase 1

Assessment phase 2 & 3

3 evaluation phases of 90 days+30 days + 30 days For ATMPs: 2 evaluation phases of 120 days + 30 days (no LoOI)

•

decision making^

Validation

30 days

30 days

Clock stop^

•

~20 days

90 days

By Day 217 EC Decision

Day 150 CHMP Opinion*

Procedure Start

Day 90 LoQ*

Day 60 Preliminary ARs

Day 120 LoOIOR CHMP opinion – immediate response

Submit

Possible oral explanation /final label updates

Day 91 LoQ Response

GMP and potential GLP, GCP INSPECTIONS

* Procedure can revert to standard timetable, based on EMA or Applicant decision ^Linguistic review may be accelerated (and EC Decision can be accelerated too in some instances)

The Organisation for Professionals in Regulatory Affairs

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Preparation is key, including after Procedure Start • Keep your internal team engaged and informed: • Best practice to hold a kick-off for next steps of the procedure e.g. Day 80 and Day 120 timelines, logistics • Align early on process for authoring responses, confirm “Rapid response team”, document approvers, labelling process etc • Use time to prepare effectively before assessment reports: • Talk to your peers for their experiences • Work on preliminary responses to potential questions and consider additional data generation • Prepare a “Label negotiation document” • Resource! Know you team! • Who are your core team, subject matter experts, document authors, reviewers, approvers, labelling team, decision makers • What else is ongoing? Any planned holidays?

The Organisation for Professionals in Regulatory Affairs

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