The European Medicines Agency has launched the PRIME (PRIority MEdicines) scheme, which offers early, proactive and enhanced support to medicine developers to optimise the production of robust data on a medicine’s benefits and risks and enable accelerated assessment. To support earlier access to patients, the Commission has shortened the timeframe for adopting decisions that authorise medicines for unmet needs that have been evaluated under an accelerated assessment procedure.
According to the EU Commissioner for Health and Food Safety, “The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs. Through enhanced scientific support this scheme could help, for example, to accelerate the development and authorisation of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance. It is also a potential godsend for those suffering from diseases for which there are currently no treatment options, such as rare cancers, Alzheimer’s disease and other dementias. Furthermore, it optimises the use of the current regulatory framework that can contribute to the European Commission’s priorities in terms of boosting innovation, jobs, growth and competitiveness.”
For more information on PRIME and the European Medicines Agency, on the ema.europa.eu website