The accelerated drug approval procedure, Priority Medicine (PRIME), was initiated by the EMA (the European Medicines Agency) in March 2016. Its mission is to pave the route of official approval and marketing authorization for specific drugs being developed for the treatment of unmet medical needs.
PRIME allows applicants to get confirmation – as early as on the stage of clinical development – for their drug being potentially eligible for accelerated assessment. Through early dialogue and enhanced interaction with the promising drug developers, the procedure facilitates optimization of development plans and acceleration of evaluation processes.
Patients’ benefit from PRIME is early access to therapies which may bring to improvement in their life quality.
Pharma’s benefits include proactive, early-stage support from the Agency to accelerate application assessment through optimization of the drug benefit-and-risk data generation process and further marketing authorization.
Eligible for benefiting from PRIME are the drugs that can demonstrate their potential to bring significant therapeutic advantages to patients:
- with unmet medical needs
- with life-threatening or debilitating diseases
- with rare diseases
- in emergency situations posing threat to public health.
If the CHMP resolves that the drug is of major importance for public health, and especially if it introduces therapeutic innovation, the application becomes eligible for the PRIME accelerated assessment procedure.
After being acknowledged eligible for PRIME procedures, the drug is appointed a Rapporteur from CHMP (Committee for Medicinal Products for Human Use) who supports the process in the following ways:
- provides scientific counsel at crucial development milestones
- assigns a dedicated contact point in the European Medicines Agency
- organizes a jumpstart meeting with experts from the relevant scientific communities.
Advantages of Accelerated Assessment
With accelerated assessment being initiated, EMA and CHMP review the marketing-authorization application with a reduced timeframe. If under centralized procedure this review takes up to 210 days (the additional time spent on providing additional information by the applicant is not included), under PRIME procedure the review period can take as little as 150 days provided that the applicant is recognized as eligible for it.
Prerequisites for Conditional Marketing Authorization
Conditional marketing authorization is granted in the interest of public health to drugs the benefit of immediate availability of which for patients is larger than the risk of using it with data less comprehensive than normally required by legislation and guidelines.
Under PRIME procedures approval may be granted to drugs with clinical data of less volume than normally required. Nevertheless, such drugs are further subject to undergoing specific post-authorization procedures in order to provide the due complete data on them.
Requests for accelerated assessment should be submitted at least two or three months prior to presenting the marketing authorization application. To ensure timely submission of the requests for accelerated assessment, it is recommended that applicants seek guidance from a procedure manager in the European Medicines Agency.
Compassionate use: advantages and requirements
The unauthorized drug may be allowed to be used under the scheme of compassionate use. Drugs still in the process of development can be made available to patients suffering from unaddressed diseases who cannot otherwise enter clinical trials.
Rules and procedures of compassionate use programs are set, implemented and coordinated by Member States themselves. For the use of such drugs to comply with national legislation, the EMA can provide to Member States recommendations of the conditions of their use and distribution as well as regarding targeted patients.
Such national compassionate-use programs are practiced only in cases of long-lasting, seriously debilitating or life-threatening illnesses which cannot be addressed satisfactorily with the currently available authorized drugs.
Used under national compassionate-use programs can be drugs that are in the process of clinical trials or marketing-authorization with completed early study stage but no dosage guidelines and safety profile being fully established.