The EMA has launched three major new features of the PRIME scheme to increase support for the development of medicines targeting unmet medical need.[1][2] PRIME has been evolving ten years since its launch to keep pace with scientific innovation and accelerate drug development and evaluation.[1] PRIME's new features support increased regulatory agility and better support for drug developers.[1] The PRIME scheme provides early engagement with direct access to EMA regulators and timely scientific advice.[2] After being granted PRIME status, the sponsor will be assigned a dedicated officer as the single point of contact throughout the development.[2] PRIME enables an accelerated assessment of the application for drug registration, reducing the period from 210 to 150 days.[2] These new tools come at a crucial time for EMA.[1]