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RMP

Meaning

RMP, standing for Risk Management Plan, is a comprehensive regulatory document required for any new or existing pharmaceutical product, including hormonal therapies, detailing the strategy for identifying, characterizing, and minimizing the associated risks. This proactive plan goes beyond basic safety surveillance, outlining specific pharmacovigilance activities and risk minimization measures, such as patient education materials or specialized monitoring programs. The RMP ensures a favorable Benefit-Risk Profile is maintained throughout the product’s entire lifecycle.