Biotech Values

[jq1234]

EMA process isn't really "slower", review time is 210 days for regular, 150 days for accelerated, thus actually shorter to get CHMP opinion. The difference is the clock stops if they have questions for sponsors (120-day, 180-day questions etc) the clock restarts again only after sponsors respond to their questions. There isn't a similar disclosure process like CRLs from FDA, so the public don't really know when sponsors replied those questions unless companies voluntarily disclose them - some companies do but most don't disclose. IMO there should be a transparent disclosure process when 120-day clock stops, when it restarts. Often time, it is sponsor that causes delay, not EMA. But the public don't know.