Risk Management Plans (RMPs)

A Risk Management Plan is a document that describes current knowledge about the safety and efficacy of a medicine. In the European Union, companies are required to submit a risk management plan to regulatory authorities at the time of application for a new marketing authorisation. A risk management plan provides information on the following key areas:

  • Efficacy (how well the product works)
  • Important identified risks (safety issues related to use of a product)
  • Important potential risks (safety issues which have not yet been associated with use of a product to date, but which could be expected or predicted based on the mechanism of action of the product)
  • Missing information (patients or conditions where a product has not been used and where there is no clinical experience)
  • Pharmacovigilance measures (measures being taken to monitor safety issues, for example, a  description of any studies which are ongoing or planned )
  • Risk minimisation measures (activities which aim to minimise the risk of a product, for example, provision of educational materials for healthcare professionals and patients).

Risk management plans are dynamic documents which are continually modified and updated throughout the lifetime of a medicinal product, as new information about the product becomes available. In particular regulatory authorities can request a risk management plan, or an update to a risk management plan, whenever there is a concern about a risk(s) affecting the overall benefit-risk balance of a medicinal product.