Module 6

04 October 2024

Analysis of SME MAA : Method

• SME MAA between 2011-2015

• MAA Outcome (positive, negative, withdrawn)

• Major Objections: quality, non-clinical, clinical

• Type of active substance, ODD status, Therapeutic Areas/Indications

• Type of application (full or abridged)

• MO associated with MAA failure for SME?

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

Classified as public by the European Medicines Agency

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Analysis of SME MAA : Results

Withdrawn N=18

Negative MAA N=22 (34%)

SME at marketing authorisation N=64

Negative opinion N=4

Positive MAA N=42 (66%)

Average number of MO per application : 7 +/- 6 (0-24)

Negative MAA: 10+/-7 (2-24)

•

Positive MAA: 5+/-4 (0-18)

•

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

Classified as public by the European Medicines Agency

43

22