EMA launches new scheme PRIME for medicines that target unmet medical needs
On 4 March 2016, the European Medicines Agency (EMA) launched PRIME (PRIority MEdicines), a priority scheme to support medicinal products benefiting patients with no treatment options or offering a significant therapeutic advantage over existing treatments.
Through PRIME, developers of medicinal products can receive proactive and improved support from EMA to enhance the generation of data on a medicinal product’s benefits and risks. This paves the way for an accelerated assessment of medicine applications for marketing authorizations; by engaging with manufacturers in the early stages of the development of a medicinal product, PRIME strengthens the designs of clinical trials enabling the generation of high quality data needed by EMA, when assessing the quality, safety and efficacy of medicines.
PRIME is based on the regulatory framework already in place, and medicinal products under PRIME are, thus, predicted to benefit from the accelerated assessment as of the making of the marketing authorization application.
Medicines accepted for PRIME
In order for a medicinal product to be accepted for the accelerated priority status under PRIME, the medicinal product in question must show the potential to benefit patients with unmet medical needs, which will be based on early clinical data. PRIME is open to all companies showing promising preliminary clinical data, but SMEs (and applicants from the academic sector) have the opportunity to apply earlier on the basis of convincing non-clinical data together with tolerability data from initial clinical trials.
The benefits of PRIME
Once a medicinal product is selected for PRIME, EMA appoints a rapporteur (from EMA’s Committee for Medicinal Products for Human Use or Committee on Advanced Therapies) to provide ongoing assistance in building information before the marketing authorization application. Furthermore, a kick-off meeting is organized by EMA with the rapporteur and a multidisciplinary group of experts (from relevant scientific committees and working parties) to provide guidance on the general development plan and regulatory strategy, and an EMA contact is assigned. EMA provides scientific advice on key development mile stones and EMA confirms whether the medicinal product in question has potential for accelerated assessment at the time of marketing authorization application.
Guidance document on early access
Following the launch of PRIME, EMA has released guidelines on PRIME together with an overview of the early access regulatory tools (accelerated access, compassionate use and conditional MA) and revised guidelines on the implementation of accelerated assessment and conditional marketing authorization.
DELACOUR assists pharmaceutical companies with every aspect of the process of obtaining a marketing authorization for a medicinal product. Contact DELACOUR's team of life sciences specialists, if you would like to know more about the PRIME scheme.