Spring Intro 2023

30/03/2023

Accelerating Access

What ? • Regulatory mechanisms facilitating early/ expedited access to new medicines Why ? • Enable early patient access to new medicines, particularly those that target an unmet medical need or are of major public health • Offers alternative regulatory mechanisms to obtain product approval When ? • EARLY in development as early access mechanisms provide additional support for product development How ? • Multiple mechanisms to consider • Accelerated Assessment (EMA), Conditional Approval/Exceptional Circumstances (EMA), Compassionate Use (National Agencies), Adaptive Pathways (EMA), PRIME (EMA) Who ? • Regulatory, Affiliates, Clinical Research, Project Team, IP, Medical ? • EMA + National Agencies

The Organisation for Professionals in Regulatory Affairs

79

David

Tradename

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

80