What does the new EU Regulation change in terms of pharmacovigilance?
Holders of marketing authorisations (MAs) for veterinary medicinal products were previously required to provide the European Medicines Agency and Member States with a risk-benefit assessment of their medicinal products, via periodic safety update reports. These contained reports of any adverse effects and an estimate of the number of animals treated over the period, which was used to calculate the incidence of the reported adverse effects. This requirement was valid for all veterinary medicinal products, regardless of how long they had been on the market and also including known side effects.
With the new EU Regulation on veterinary medicinal products, which came into force at the start of 2022, all reports are now recorded continuously in the European database. Exploitation of this dataset will enable new adverse effects to be detected more quickly, because it focuses on the analysis of "signals", i.e. information suggesting a previously undetected adverse effect in association with a medicinal product, or a new aspect of a known adverse effect. The aim is to determine whether the benefit/risk ratio of the medicines has changed, with a view to detecting risks to animal or human health, or to the environment.
How will this change improve things?
Signal detection facilitates the prompt escalation of potential safety problems (adverse events, product interactions, etc.). The new system also reduces the administrative burden for MA holders by removing the requirement for periodic reporting.
With this signal management process, MA holders can take into account the number of animals treated and other relevant pharmacovigilance data sources of which they are aware, in particular information from scientific reviews, in order to assess the risk/benefit balance of a medicinal product in more detail.
How are the results and conclusions of this process managed?
This new signal management process will enable the authorities to take the most appropriate measures to address these adverse effects. These measures may include amending marketing authorisations, suspending or even withdrawing the medicine, requesting surveillance studies, and/or providing appropriate communication.
MA holders are required to describe in detail the signal management system they have put in place to meet their obligations. Compliance is monitored by the competent European authorities through checks and/or inspections.
Lastly, the results and conclusions of the signal management process, including the conclusion on the benefit/risk ratio, must be recorded by the MA holder in the EU pharmacovigilance database at least once a year. These data are openly available to all.