The importance and impact of the EU RMP and US REMS to risk-benefit assessments

The UE RMP is an engagement of wider scope than the US REMS, and is binding on a large set of medicines. The US REMS is compulsory only for some medicines, and can be limited to two years post product launch. The REMS concerns itself with communication of risk; with the prescriber information, the package insert (PI), being central to risk minimization. Components of a typical FDA REMS are a communication plan; patient selection; web-based materials and medical scientific liaison; elements to assure safe use; an implementation system; a patient or physician survey; and patient understanding of risk.
The EU RMP is a more comprehensive, more extensive safety package that the sponsor is obligated to follow throughout the lifecycle of all new drugs or biologics. The main components of an EU RMP are risk assessment, pharmacovigilance activities, and finally risk minimization activities (which are mainly associates with SmPc and PL).

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