The European Medicines Agency (EMA) has launched a public consultation on the key principles of its new PRIME scheme. PRIME aims to strengthen support to medicines that have the potential to benefit patients who presently have no treatment options, or that may offer a major therapeutic advantage over existing treatments. These are considered priority medicines by EMA, hence the name of the scheme. Through the scheme, EMA will offer early and enhanced scientific and regulatory support to medicine developers to optimize the generation of robust data and enable accelerated assessment.
PRIME builds on existing regulatory tools, particularly scientific advice and the accelerated assessment procedure which is used for medicines of major interest from a public health and therapeutic innovation perspective. Key proposed features of PRIME include: written confirmation of PRIME eligibility and potential eligibility for accelerated assessment; early appointment of a rapporteur from EMA’s Committee for Medicinal Products for Human Use (CHMP) to facilitate continuity in support and building of knowledge in view of the submission of a marketing authorization application; kick-off meeting with a multidisciplinary group of experts from relevant EMA scientific committees and working parties to give preliminary guidance on the overall development plan and recommended regulatory pathway; scientific advice at key development milestones with potential involvement of multiple stakeholders (e.g. health technology assessment bodies and patients), when relevant.
To be granted a marketing authorization in the European Union (EU), medicines that benefit from PRIME during their development will have to demonstrate that their benefits outweigh their risks, like any other medicine. The same high evaluation standards will be applied to all medicines, whether they receive PRIME support or not.
The eligibility criteria foreseen for PRIME are those of the accelerated assessment procedure. This means that to be eligible to enter the scheme, a medicine would have to show preliminary clinical evidence indicating that it has the potential to bring significant benefits to patients with unmet medical needs and hence be of major interest from a public health and therapeutic innovation perspective.
Earlier entry into the scheme on the basis of compelling nonclinical data and tolerability data in initial clinical trials is envisaged for micro-, small- and medium-sized enterprises (SMEs) and applicants from the academic sector. This aims to provide further support to these sponsors who are known to play a key role in the development of innovative medicines and may benefit even more from PRIME support. SMEs whose medicines are eligible for PRIME would be able to benefit from the fee incentives on scientific advice that the agency makes available to these companies.
EMA has published a reflection paper outlining the proposed eligibility criteria, procedure, key features and data requirements for PRIME. Comments are invited by December 23, 2015 to the EMA. The launch of PRIME is planned for the first quarter of 2016.
Source: European Medicines Agency