CRED 8 Presentations

01/07/2024

Scientific Advice and Probability of MA Success

• Obtaining and complying with SA appears to be a predictor of outcome / Obtaining SA early in development and at major transition points as well as compliance with the advice given by the CHMP are recommended.

Total of 118 MAAs submitted in 2008-2012 for which SA had been received.

SA assessment MAA assessment MAA outcome

Positive (n=32; 84%) Negative (n=6; 16%) Positive (n=43; 86%)

Acceptable (n=39; 33%)

Compliant* (n=38; 97%)

Regnstrom, J., et al. Eur J Clin (2009)

Total (n=118)

• There is a correlation between compliance with scientific advice,

Compliant (n=50; 63%)

Total (n=118)

Negative (n=7; 14%)

maintenance of accelerated assessment and a positive marketing authorisation procedure outcome, confirming the findings of previous studies

Non acceptable (n=79; 67%)

Positive (n=12; 41%) Negative (n=17; 59%)

Non-compliant (n=29; 37%)

https://www.ema.europa.eu/en/documents/report/pri me-analysis-first-5-years-experience_en.pdf

Hofer, M., et al. Impact of scientific advice from the European Medicines Agency. Nat Rev Drug Discov 14, 302–303 (2015).

The Organisation for Professionals in Regulatory Affairs

25

FDA designations for drug development scientific advice opportunities and impact on MA approval

Michaeli, D.T., et al. Eur J Health Econ (2023).

The Organisation for Professionals in Regulatory Affairs

26