Risk Management Plans (RMP)

The risk management plan (RMP) should be submitted as part of the dossier of all new drug applications in the European Economic Area (EEA) and is evaluated by regulatory authorities before a medicine can be authorized. The RMP provides information on a medicine’s safety profile, describes the activities of the marketing authorization holder to further characterize the safety profile during post-marketing (pharmacovigilance activities), and explains the measures that are taken in order to prevent or minimize the medicine’s risks in patients (risk minimization measures). A positive risk-benefit balance for the target population is required to receive the market authorization and a constant reassessment of this risk-benefit balance ensures the patient’s benefit and safety. The RMP specifies the mechanisms that are applied to identify, analyze, mitigate, and monitor the potential risks and is a living document that changes during the life cycle of the health product as new information becomes available.

Med Communications can support you with the preparation of a new RMP as well as with updates to an existing document, using current knowledge on Competent Authority requirements and making sure the plan contains all the important information to support the market authorization of your product without delays during the process.

Key information that should be outlined in the RMP include:

• Identification and characterization of the safety profile of the medication, including important identified and potential risks as well as missing information.
• Planning of the pharmacovigilance activities for the product to monitor and acquire new information.
• Planning and implementation of measures for risk minimization and the evaluation of their effectiveness.