Scientific advice leads to stronger applications from industry, says EMA

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorisation.

These are the main findings of an analysis of MAA outcomes between 2008 and 2012 conducted by staff members of EMA and its Scientific Advice Working Party (SAWP) and published in Nature Reviews Drug Discovery.

The EMA, through its SAWP, provides scientific advice to companies during the development of their medicines to help them design trials that are scientifically sound and generate adequate data for the benefit-risk assessment by EMA’s Committee for Medicinal Products for Human Use (CHMP).