Risk management plan as administrative and clinical tool Review article

Abstract

As part of the pharmacovigilance of PV (pharmacovigilance), global regulations concerning the risk management plan (RMP) were introduced. In accordance with the requirements of the RMP, the processes of safety monitoring and risk minimization are systematically planned and implemented by the responsible entities. The RMP is a detailed plan submitted to regulatory authorities in parallel with the registration of a medicinal product. Risk minimization measures are those that apply to any medicinal product. For medicinal products that do not have an RMP, it may be required for any application that involves a substantial variation of the marketing authorization. The risk management plan focuses on those hazards that are relevant to the risk management activities of an authorized medicinal product. Among the identified risks of a medicinal product, this plan addresses those which are clinical adverse effects and for which there is sufficient scientific evidence that they are caused by the medicinal product in question.