Spring Intro 2023

30/03/2023

What, Why, When and How ?

What & Why ? • Regulatory mechanisms to help promising new medicines reach patients as early as possible When ? • Early during clinical development • During clinical development based on preliminary clinical evidence How ? • Multiple mechanisms

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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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