Incident management plan

The European Medicines Agency (EMA) set up the incident management plan for medicines for human use as a framework for the identification and management of incidents within the European medicines regulatory network.

Updated on 14 November 2025:
- to add new section on the scope of the incident management plan
- to update the section related to the exchange of information on safety concerns

EMA set up an incident management plan for medicines for human use. It aims to establish a framework for identifying and managing incidents within the European medicines regulatory network.

Incidents can arise from new data on a medicine’s quality, safety, or efficacy at any stage of its lifecycle. In some cases, these incidents may develop into major events, as referred in the regulation reinforcing EMA’s role (Regulation 2022/123).

These incidents may affect public health and/or have implications for the network's policies and reputation.

The plan aims to prevent incidents from becoming major events and, where needed, to escalate them to EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

The second revision of the plan includes lessons learned from previous incidents and the COVID-19 pandemic. It also reflects the changes brought by Regulation 2022/123.

For the full incident management plan, including its objectives, activities, rules of procedure and composition, see:

European medicines regulatory network incident management plan for medicines for human use

Reference Number: EMA/351583/2012 Rev. 2

For more information, see:

• Regulation 2022/123
• Pharmacovigilance: post-authorisation
• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

Scope of incident management plan

Incidents that fall within the scope of the incident management plan may be related to:

• quality, e.g., non-compliance with previous approved product manufacturing process or specifications;
• efficacy, e.g., reduced potency of the product;
• safety, e.g., viral contamination of biological products.

The incident may involve one or multiple medicines authorised in the EU. The medicines may have been authorised through any of the following procedures:

• Centralised procedure
• Mutual recognition
• Decentralised procedure
• National procedure

New safety information arising from clinical trials that may affect the safe use of medicines in the approved indication also falls within the scope of the plan. 

Crisis simulation exercise

In October 2017, EMA carried out a crisis simulation exercise testing the adequacy of the incident management plan in a potential crisis situation. The test showed that the processes are working well. 

EMA is using lessons learned from the exercise enabled to further streamline relevant procedures and guidance.

For more information on the exercise, see the document below:

Crisis simulation exercise coordinated by European Medicines Agency in October 2017

Reference Number: EMA/37396/2018

Exchange of information on safety concerns

The incident management plan uses the pharmacovigilance rapid alert and non-urgent information systems to quickly exchange information on safety concerns within the European medicines regulatory network.

The European Commission also has in place a system for the management of rapid alerts arising from quality defects risk assessments. This system ensures that the network and other relevant partners are quickly informed about the recall of medicinal products due to:

• quality defects;
• falsification;
• urgent action to protect public or animal health.

For more information, see:

• Management of rapid alerts arising from quality defects risk assessment
• Compilation of Union procedures on inspections and exchange of information