EMA PRIME Rejects Told: ‘Add Something New’ If You Resubmit
Executive Summary
The European Medicines Agency says it has been disappointing to see previously rejected applications for its PRIME scheme sent back to the agency with no additional data. On the other hand, the scheme, which is designed to get drugs for unmet medical needs to patients faster, is going from strength to strength. Kick-off meetings are identifying issues that sometime surprise companies but can be dealt with early on, well before a product is filed for authorization.