Signals reports in human medicines
As described in the latest revision of GVP Module IX on Signal Management, Marketing Authorization Holders (MAHs) have the obligation to continuously monitor EudraVigilance data and inform the EMA and National Competent Authorities of validated signals detected in the database. They are all responsible for detecting and managing safety signals associated with medicinal products for human use.
A signal is any information from one or more sources, including observations and experiments, that suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, whether adverse or beneficial, that is considered of sufficient probability to warrant verifying action. New aspects of a known association may include changes in the frequency, distribution (e.g., sex, age, and country), duration, severity, or outcome of the adverse reaction.
A signal usually refers to all medicinal products containing the same active substance, including combination products. Certain signals may be relevant only for a particular medicinal product or in a particular indication, strength, pharmaceutical form or route of administration, while some signals may apply to an entire class of medicinal product.
Indicate that, as defined in Article 23 of Regulation (EC) No 726/2004 (REG) and Article 11 of Directive 2001/83/EC (DIR), the Agency, in collaboration with the Member States, shall establish, maintain and make public a list of medicinal products subject to additional monitoring.
These medicinal products shall be easily identifiable by means of a black inverted equilateral triangle on the upper right-hand side, as stipulated in Implementing Regulation (EU) No 198/2013. Such triangle shall be followed by an explanatory statement in the summary of product characteristics (SmPC) as follows:
“This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. Healthcare professionals are kindly requested to report any suspected adverse reactions.”
The start of the pilot group that started on February 22, 2018, CTs of the active substances included in the following list have to monitor them in EudraVigilance and inform the EMA and national competent authorities of the validated signals with their medicines.
Recently, in August 2023, the EMA and the European Commission have agreed to extend the pilot until the end of 2024. The MAHs with active substances included in the list should continue to monitor them in EudraVigilance for the duration of the pilot.
Azierta Part of QbD Group can assist you in signal detection reporting services for human medicines.