Module 6

04 October 2024

Analysis of ODD MAA : Results

40

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

Classified as public by the European Medicines Agency

40

Analysis of ODD MAA : Results

• Factors associated with MAA success for ODD:

Company size

•

SA compliance

•

• 51 ODD MAA used SA before MAA and showed positive effect of SA compliance

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

Classified as public by the European Medicines Agency

41

21