Early access to medicines - Development support and regulatory tools
PRIME is a scheme launched by the Agency to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
Through PRIME, the Agency 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 applications.
PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. This means that 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.
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