Towards improved safety monitoring of veterinary medicines

News 06/06/2018

Companies are encouraged to report all suspected side effects in EudraVigilance Veterinary

The European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted the first revision of its recommendation for the basic surveillance of medicines for animals in EudraVigilance Veterinary (EVVet), the European Economic Area (EEA) database of suspected adverse reaction reports for veterinary medicines. The aim of this revision is to encourage marketing authorisation holders to report serious, as well as non-serious suspected adverse reactions to veterinary medicines for more efficient detection and evaluation of potential safety issues in the EEA, which supports the protection of animal and public health.

Before a veterinary medicine can be authorised, its safety must be studied first in clinical trials. However, certain adverse reactions would only emerge once a medicine is used in a larger number of animals, for a longer period of time or in combination with other medicines. Therefore, EMA and the national competent authorities in the Member States continuously monitor and assess the safety of approved medicines in a process known as pharmacovigilance.

This process has two main components: the compulsory reporting by companies of serious suspected adverse reactions in EVVet, and the more formal assessment of periodic safety update reports (PSURs). These reports are submitted by companies at regular intervals to allow for a critical evaluation of the benefit-risk balance on the basis of all adverse reaction reports, both serious and non-serious.

EMA and national authorities analyse EVVet data on a frequent basis whereas PSURs are only assessed according to timelines laid down in legislation, between six months and up to three years.

Experience has shown that regulatory actions are triggered earlier if a signal is identified based on the analysis of EVVet data. The revised recommendation encourages companies to also report non-serious adverse reactions to EVVet, and to simplify PSURs for those veterinary medicines where all suspected adverse events, including non-serious reports, are submitted electronically to the EVVet database. The new approach will allow regulators earlier access to more safety data and the possibility of triggering regulatory action sooner. It will also reduce the duplication of efforts in the preparation and the assessment of PSURs.

The implementation of the recommendation is voluntary for marketing authorisation holders.

The revised recommendation follows a pilot project that allowed participating marketing authorisation holders to submit PSURs with reduced requirements while also submitting non-serious reports electronically; and also takes into account the experience and feedback from a public consultation with stakeholders. In addition, an upgrade of the EVVet database is under development to provide improved tools for statistical analysis of adverse events.

Information on all pharmacovigilance activities for veterinary medicines is available on our website.

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