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Module 1.11 Single System REMS vs. Shared REMS Design & Planning

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Module 1.11: Single REMS vs. Shared REMS Design and Planning provides an overview of the regulatory and operational considerations involved in designing and managing single-system versus shared-system REMS programs. The module explains when each model is appropriate, highlighting the transition from a single REMS for brand-name products to a shared REMS when generics enter the market. It outlines the structure, benefits, and governance of shared REMS programs, including cost-sharing, operational efficiencies, and reduced stakeholder burden. The module also addresses key development considerations, consortium management, FDA communication, and submission strategies, including the use of a Type V Drug Master File, to support compliant and coordinated REMS implementation.