Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

PRIority MEdicines (PRIME) – a scheme by the EMA to accelerate the development of medicines that target an unmet medical need

Dr. Konstanze Eisfeld (Abschlußjahr: 2016)

Summary
In March 2016 the EMA launched a new scheme whose aim is to accelerate the development of new medicinal products intended to target an unmet medical need. This scheme is called PRIME (Priority Medicines). PRIME is not a new authorization pathway but a combined approach making use of the regulatory tools already available in the EU, such as scientific advice, parallel scientific advice with HTA bodies, accelerated assessment and conditional marketing authorization.
After eligibility to the scheme has been granted, applicants can benefit from the following features: appointment of a dedicated contact point at the EMA, early appointment of the CHMP Rapporteur, a kick-off meeting with the CHMP Rapporteur and a multidisciplinary EMA expert team, regular scientific advice at key milestones during the development of the product and early confirmation that the new product is potentially eligible for the accelerated assessment procedure.
Although PRIME is open to all applicants developing new medicines that target an unmet medical need, it offers bigger advantages for applicants from SMEs or academia compared to other applicants. Not only are applicants from SMEs and academia allowed to enter PRIME already with the help of proof-of-principle data whereas other applicants can only apply for the scheme later on based on proof-of-concept data, applicants from SMEs and academia will also benefit more from the close and constant collaboration with the EMA as they are usually less experienced than applicants from bigger pharmaceutical companies. Therefore, PRIME offers them guidance through the necessary regulatory requirements to get the new product authorized, but also makes those applicants aware of the different regulatory options available to get the product approved. PRIME should help overcome the early obstacles applicants from SMEs and academia might face and in the end decrease the likelihood that promising new therapeutic options developed by SMEs and academia get lost on the authorization pathway due to the inexperience of the applicants.
As PRIME mainly makes use of existing regulatory tools, most of the features of PRIME are not new to applicants from large or intermediate sized companies - they are often either already making use of those tools or are at least considering using them. Therefore the biggest advantages PRIME offers to them is the early confirmation of the potential eligibility of the new product to the accelerated assessment and especially the early appointment of the CHMP Rapporteur.
As experience with PRIME is still limited due to the short period of time the scheme has been running, it is not yet possible to fully evaluate the success of the scheme. This will be possible once the first medicines granted access to PRIME have been authorized.
Pages: 71, Annexes: pages : 0