Let’s Make It Fast
European Medicines Agency (EMA) is initiating an accelerated designation program for innovative drugs PRIME (PRIority MEdicines) .
European regulatory agency suggests something which has much in common with Breakthrough Therapy Designation therapy , established by FDA (USA) and actually is its equivalent.
EMA initiative suggests help to pharmaceutical companies in collection and submission of clinical study data and required documents.
According to European regulatory agencies PRIME program will help soonest development and registration of drugs, which is particularly important when it comes to treatment of rare diseases, including cancers, Alzheimer disease and other disorders that cannot be effectively treated with the existing methods.