May 19, 2015
The EMA recently reported that the importance of adhering to “EMA scientific advice on trial design results in higher success rates, shorter overall assessment time and fewer major objections during assessment“.
During the development of medicines, companies can seek the EMA’s advice to design scientifically sound trials and generate adequate data to support the EMA Committee for Medicinal Products for Human Use (CHMP)’s benefit risk assessment. The EMA offers this service through its Scientific Advice Working Party (SAWP). The EMA and its SAWP performed an analysis of marketing authorisation application outcomes between 2008 and 2012 (published in Nature Reviews Drug Discovery). They discovered that the “majority of clinical development plans submitted for scientific advice to the EMA prior to a marketing authorisation 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“.
Detailed analysis of applications for marketing authorisation received by the EMA, which received an opinion between 2008 and 2012, are available on the EMA website in the “Impact of scientific advice from the European Medicines Agency” report.
The EMA reiterated that scientific advice should be sought early during medicine development as it offers an opportunity to initiate a scientific dialogue on all aspects of development and will ensure that appropriate changes are implemented where necessary.