Bridging The FDA/EMA Drug Approvals Gap
This article was originally published in SRA
Executive Summary
Pharmaceutical companies still tend to seek new drug approvals from the US Food and Drug Administration before applying for marketing authorization in the EU, but this could change as a result of initiatives like the European Medicines Agency's PRIME (priority medicines) and its parallel scientific advice procedure with health technology assessment bodies, according to a new report from regulatory consultancy NDA Group1.