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EMA Tells Companies How To Boost Their Approval Chances Under PRIME

 
• By Neena Brizmohun

Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.

Medic staff at work in the laboratory. Background
PRIME helps companies optimize development plans for drugs for unmet medical needs • Source: Shutterstock

The European Medicines Agency is seeking to help developers of investigational drugs that have been accepted onto its PRIME (priority medicines) scheme to maximize their chances of quickly developing and winning marketing approval for their products.

Experience to date has shown that developers face difficulties when it comes to preparing robust quality data packages for their products in the scheme, which was launched in 2016 to...

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