A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions
Risk Management Plan
A Risk Management Plan (RMP) is the document submitted as part of the Marketing Authorization Application that describes the activities and interventions designed to identify, characterize, prevent or minimize risks relating to a medicinal product, including the assessment of the effectiveness of those interventions and document post-authorization obligations that have been imposed as a condition of the marketing authorization updated throughout the lifetime of the medicine as new information becomes available.
RMPs include information on a medicine’s safety profile, how its risks will be prevented or minimized in patients, plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine, risk factors for developing side effects, measuring the effectiveness of risk-minimization measures.
Risk Management System in the European Union
The concept of RMP is specific to EU/EEA region. For medicines that do not have an RMP, it is likely that one will be required with any application involving a significant change to the marketing authorisation. In addition, any national competent authority (NCA) in the EU can request an RMP whenever there is a concern about a risk affecting the benefit-risk balance of the medicine. The RMPs are continually modified.
Risk Management System in the USA
In the USA, a REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. An applicant may voluntarily submit a proposed REMS without having been required to do so by FDA. For instance, without having been notified by FDA to submit a proposed REMS, an applicant may include a proposed REMS in an original application or in a supplemental application, or in an amendment to an existing original or supplemental application, if the applicant believes a REMS would be necessary to ensure that the benefits of the drug outweigh its risks.
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product and can be comprised of: Medication Guide, Patient Package Insert, including a communication plan elements to assure safe use, and an implementation system.
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