Module 6

04 October 2024

Evaluation and Key Milestones of Initial MAA

15 days following EC decision

Post Day 10 Clarification meeting

Day 120

Day 180

Day 277

Day 121-180

Day 170-180

Decision making

Day 150

Day 80

CHMP discussion Clock stop extension

CHMP discussion Clock stop extension

Day 0

EC Decision

Day 80-100

Day 181-210

Day 210 277 (+15 days if needed)

SAG Expert group

D150 JAR ASMF Similarity NAS

D80 AR ASMF Similarity NAS

MS Comments

Post D180 Clarification meeting

Post D120 Clarification meeting

EPAR publication

D195 JAR MS Comments D203 JAR Oral Explanation Opinion and its final CHMP AR

Peer review MS Comments

Timetables (TT) (standard, AA, ATMP)

EPAR consultation

Note: In italics, upon request by EMA/CHMP and/or if the criteria are met: Active Substance Master File (ASMF), similarity, NAS: New Active Substance

An Agency perspective: the success and failure of a medicinal product in the EU

36

Classified as public by the European Medicines Agency

36

CHMP Negative Trend: What happens?

EC decision

Negative opinion - By consensus - By majority with divergent positions

Withdrawal still possible before EC decision

CHMP Negative Trend

No new data !

Reexamination of the opinion

Withdrawal of the application

EMA Publication

Negative opinion - Refusal Q&A

EC decision - Refusal EPAR

Reexamination of the opinion - Re-examination Q&A - +/- summary of opinion

Withdrawal of the application - Withdrawal Q&A, letter - Withdrawal EPAR

An Agency perspective: the success and failure of a medicinal product in the EU

37

Classified as public by the European Medicines Agency

37

19