Spring Intro 2023

30/03/2023

How ? Accelerating Access to Patients

PRIority MEdicines (PRIME) • Scheme to optimise development of priority medicines and facilitate patient access Accelerated Assessment • Can shorten MAA review timeframe from 210 to 120 days Conditional Authorisation • Allows authorisation with less comprehensive data than normally required Approval under Exceptional Circumstances • Comprehensive data on the efficacy and safety cannot be provided under normal conditions of use Adaptive Pathways • Provides a framework for informal dialogue between stakeholders, including patients and health-technology-assessment bodies Compassionate Use • allows the use of an unauthorised medicine for patients with an unmet medical need

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PRIME PRIority MEdicines

EMA scheme to bring promising innovative medicines to patients faster • By optimising and supporting medicine development • The first medicines that were facilitated by PRIME are just beginning to see approvals For medicines • That address an unmet medical need • With preliminary data demonstrating the potential to address this need Using • early enhanced support to optimise development • faster evaluation • existing regulatory framework • scientific advice, accelerated assessment

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