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Through the PRIME (PRIority MEdicines) scheme, the European Agency (EMA) offers early and proactive support to medicine developers to optimise the generation of robust data on a medicine's benefits and risks and enable accelerated assessment of medicines applications in EU.

This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life. Developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation. PRIME is open to all companies on the basis of preliminary clinical evidence. Applicants from micro, small and medium-sized enterprises (SMEs) can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.

Key PRIME benefits for applicants are:

  • Early appointment of a Rapporteur from the Committee for Medicinal Products for Human Use(CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy to provide continuous support and help to build knowledge ahead of a marketing-authorisation application;
  • Kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts, so that they provide guidance on the overall development plan and regulatory strategy;
  • Assign a dedicated contact point;
  • Scientific Advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;
  • Confirmation about potential for accelerated assessment at the time of an application for marketing authorisation.

How we support you

We will support you in assessing the PRIME eligibility and we will provide full assistance during the implementation phase of the procedure.

Talk to one of our experts

On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.