Public consultation starts on PRIME – a new scheme to optimise development of priority medicines and facilitate patients’ access.
PRIME aims to reinforce scientific and regulatory support to medicines of major public health interest
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 optimise the generation of robust data and enableaccelerated assessment. This will allow patients to benefit from therapies that may significantly improve their quality of life as early as possible.
PRIME builds on existing regulatory tools, particularly scientific advice and theaccelerated 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 authorisation 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.
By providing enhanced support to medicines that address unmet medical needs, EMA will encourage developers to focus their resources on those candidate medicines that are likely to make a real difference to a patient’s life. PRIME also aims to strengthenclinical trial design so that patients participate in trials that are likely to provide the necessary data for an application for marketing authorisation.
To be granted a marketing authorisation 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.
EMA has published a reflection paper outlining the proposed eligibility criteria, procedure, key features and data requirements for PRIME. Comments are invited by 23 December 2015 and should be submitted to prime@ema.europa.eu using the form provided.
The launch of PRIME is planned for the first quarter of 2016.
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