Emerging Safety Issue

An emerging safety issue denotes a safety concern that a marketing authorization holder deems to demand immediate attention from the competent authority due to its potential to significantly impact the delicate balance between a medicinal product’s risks and benefits, as well as its potential ramifications on patient well-being and public health.

The urgency of addressing such issues arises from the possibility of substantial effects, necessitating swift regulatory measures and timely communication to both patients and healthcare practitioners to ensure their welfare and informed decision-making.