CRED ERP 25

01/07/2025

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

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