Marketing Authorization More Likely for Companies Following EMA Clinical Development Plans

The European Medicines Agency (EMA) has released findings from its marketing authorization application analysis conducted between 2008 and 2012 by EMA’s Scientific Advice Working Party (SAWP). The findings, which were published in Nature Reviews Drug Discovery, state that companies that followed EMA recommendations for clinical development plans were more likely to be granted marketing authorization.

According to EMA, the majority of the plans that were submitted for scientific advice prior to marketing authorization were not suitable for future benefit-risk assessment. The SAWP provides companies with scientific advice on how to 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).”

Details about the marketing authorization applications reviewed during the analysis period found that “two out of three programs submitted for scientific advice had poor clinical trial designs that were inadequate to generate data for the assessment of the benefits and risks of the medicine.”  The analysis also found that companies that had an acceptable trial design or that changed their trial design to conform with scientific advice recommendations “equally increased the likelihood of a positive outcome with success rates of 84% and 86% respectively, compared with only 41% when a deficient clinical trial design was not adapted according to scientific advice recommendations.” According to the analysis, compliance with scientific advice reduced CHMP objections and reduced the application assessment time on average, resulting in patients receiving the drugs sooner.

Source: EMA