The incident management plan aims to ensure that concerned bodies in the European Union (EU) take appropriate action whenever incidents (new events or information) arise concerning human medicines. It covers medicines authorised centrally, nationally and through the decentralised and mutual-recognition procedures.
The incident management plan for human medicines has been in operation within the EU regulatory network since September 2009.
The plan's execution involves representatives from the European Medicines Agency, the European Commission and medicines regulatory authorities in the EU Member States.
Since its inception, the plan has been reviewed and amended, including amendments to reflect the provisions in the 2010 pharmacovigilance legislation.
Proactive and reactive management
The incident management plan involves the continuous monitoring of incidents that may have a serious impact on public health. Although incidents may relate to quality, safety or efficacy concerns, they usually involve issues related to pharmacovigilance, such as a new safety hazard. However, they can also involve issues related to both safety and quality concerns. In addition, situations such as supply shortages caused by manufacturing or good-manufacturing-practice compliance problems also fall within the scope of the incident management plan. This proactive incident management aims to prevent incidents developing into crises.
In more extreme situations, the plan explains the urgent steps needed to manage crises in a reactive manner.
Exchange of information within the EU
The plan includes a system for the rapid exchange of information on safety concerns across the EU via the rapid-alert and non-urgent-information systems.
The incident review network reviews incidents from a managerial perspective in terms of their impact on public health and the measures needed to address them.
The activities in the plan and of this managerial group focus on managing incidents and do not replace the work of the Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Exchange of information outside of the EU
EMA collaborates with regulators outside the EU in the area of pharmacovigilance in the framework of a ‘pharmacovigilance cluster’. The primary goal of the cluster is to exchange information on risk assessments (with special focus on emerging safety concerns, including those assessed in EU referral procedures) and informing the participating parties of anticipated regulatory action, including public communication, prior to decision-making and publication.
For more details on the pharmacovigilance cluster, see our page on cooperation with the United States.
Full details on the incident management plan, including its objectives, activities, rules of procedure and composition, see
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