IX.B.4. Signal prioritisation

Every organisation should consider throughout the signal management process whether signals suggest risks with an important impact on patients’ or public health and/or on the risk-benefit balance of the medicinal product (see IX.A.1.1.).

The following should be considered when evaluating this impact:

• the severity, seriousness, outcome and reversibility of the adverse reaction and the potential for prevention;
• the patient exposure and the estimated frequency of the adverse reaction;
• the patient exposure in vulnerable populations and/or in populations with different patterns of use, where appropriate;
• the consequences of treatment discontinuation on the disease under treatment and the availability of other therapeutic options;
• the expected extent of the regulatory intervention (e.g. addition of adverse reactions, warnings, contraindications, additional risk minimisation measures, suspension, revocation);
• whether the signal is likely to apply to other substances of the same class of medicinal products.

In some circumstances, signals that could cause media attention and/or public concerns (e.g. adverse events following mass immunisation) may deserve special attention.

The timeframe for further management of the signal will depend on the prioritisation. Appropriate measures should be considered at any stage if the information available suggests that there could be a risk that requires prevention or minimisation in a timely manner (see GVP Module XVI). Such measures may be required before a formal assessment of the signal is concluded. Clinical judgement and flexibility should be applied throughout the process.