PRIME (PRIority MEdicines) is an initiative to encourage the development of medicines that would benefit patients and support innovation. Medicinal products for human use, which are innovative treatments – in particular those targeting diseases with high unmet medical need – may be considered eligible for PRIME at the time of the marketing authorization application. If they are eligible, the applicant pharmaceutical company will receive an early confirmation of their eligibility to the PRIME scheme at the time of marketing authorization application. This might shorten significantly the assessment time in case of agreement with all concerned Member States.
PRIME is for innovative medicinal products with a medical, therapeutic or public health need. For example, PRIME is intended for the treatment of orphan diseases and other diseases that have a high level of unmet medical needs.
The product must have a new active substance discovered by means of a biotechnological process, or an innovative method used in manufacturing the product to be placed on the market in Europe based on a complete dossier.
The product must be expected to have significant therapeutic impact with respect to safety and/or efficacy compared to existing therapies or no marketed equivalent of its active substance(s) in the same pharmaceutical form.
PRIME offers speedier access to medicine for patients by reducing the timeframe of the assessment to just 210 days in case of agreement with all concerned Member States.
The cost-effectiveness review that is part of an applicant company’s strategy for PRIME may be waived in exceptional circumstances if the product has a high added value and patient access through PRIME would enable more patients to benefit from it within the designated timeframe.
PRIME is intended to encourage companies to invest in R&D by reducing the phase of uncertainty and risk associated with developing innovative medicines. PRIME provides early confirmation of eligibility, allowing pharmaceutical companies to make better informed decisions about research and development (R&D) potential and timelines.
Companies may also be able to take into account this fast-track option in their pricing and reimbursement strategy, as early confirmation of eligibility reduces the phase of uncertainty and risk associated with developing innovative medicines.
What are the conditions for reaching agreement?
The assessment will focus on the therapeutic impact with respect to safety and/or efficacy of an eligible PRIME medicine in comparison to existing therapies, or no marketed equivalent of its active substance(s) in the same pharmaceutical form.
The assessment will also focus on the characteristics of the disease and/or patient population targeted by an eligible PRIME medicine when compared to existing treatment options.
Member States agree to assess applications for marketing authorization in 210 days – including the time required to hold a centralised procedure meeting – in case of agreement with all concerned Member States.
The assessment might be up to 30 days longer if specific questions need to be addressed that are related to the application, for example additional manufacturing information or clarification about an aspect of the nonclinical or clinical data.