Accelerated Assessment Decision ‘Imminent’ For Two Products In EMA’s PRIME Scheme
The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.
You may also be interested in...
Companies won’t necessarily lose their place on the European Medicines Agency’s priority medicines scheme if a competing product gets to market first. And they shouldn’t be put off by the fact that competing products are already on the scheme.
Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.