EMA To Speed Up Orphan Approvals By Closing Gap Between CHMP, COMP Opinions
Executive Summary
The European Medicines Agency has initiated steps to ensure that the opinions issued by its human medicines evaluation committee and the orphan drugs committee for certain types of innovative orphan drugs reach the European Commission at around the same time. While the move is expected to facilitate an earlier decision on the marketing authorization applications of such products, industry says it does not go far enough.