The European Medicines Agency (EMA) Monday launched its new PRIME (PRIority MEdicines) scheme to expedite the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials, according to a statement by EMA.
The scheme focuses on those drugs that are considered priority medicines within the European Union (EU) and offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options.
"Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines. Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible," said Professor Guido Rasi, EMA's Executive Director, in the statement.
EMA expects about 100 applications a year for the PRIME scheme, which aims to foster better planning of medicine development to help companies generate the data needed for rapid approval, Reuters reported.
According to Vytenis Andriukaitis, EU commissioner for health and food safety, this move could help speed up development and approval of treatments for several conditions with a few options available at present, such as rare cancers and Alzheimer's disease. He also said that it may also help accelerate commercialisation of new classes of antibiotics, which are badly needed given the rise of antimicrobial resistance.
Through PRIME, experimental drugs will get continuous support from an EMA expert, who will be appointed early in the process and will provide guidance on the overall development plans and regulatory strategy, according to the statement.
PRIME was developed in consultation with the Agency's scientific committees, the European Commission and its expert group on Safe and Timely Access to Medicines for Patients (STAMP) as well as the European medicines regulatory network.
In 2012, the U.S. Food and Drug Administration (USFDA) had introduced a successful "breakthrough" designation, which helps in speeding up approval of innovative drugs for cancer and other serious diseases.
