1 Oct 2026
Analysis concludes financial burden of regulatory activities is growing faster than both EU inflation and its members’ turnover.
Chris Simpson
Job Title
A group representing the generic veterinary medicines industry across Europe has warned of the impact of an increasingly complex regulatory framework as it shared fresh insight into the associated costs.
Access VetMed, which represents 31 generic and added-value veterinary medicines companies holding 52% of all generic veterinary medicines marketing authorisations in Europe, highlighted rising regulatory and pharmacovigilance costs in its annual general assembly.
The group surveyed its members to assess the administrative and financial burden regulatory activities place on companies, with its findings revealing a continuous increase in human resources allocated to regulatory affairs and pharmacovigilance since 2018.
Regulatory affairs resources increased by an average of 7.4% from 2024 to 2025 while pharmacovigilance rose by 6%.
It also revealed that on average last year, variation fees, regulatory fees and other regulatory and IT costs increased by 12.9%, 16% and 15.6% respectively.
Pharmacovigilance budgets increased by an average of 22%, although with significant variation between companies, said to be largely linked to new annual pharmacovigilance fees.
AccessVetMed concluded the financial burden is growing faster than both EU inflation and its members’ turnover, and that small and medium-sized enterprises (SMEs) are disproportionately affected.
However, it did not identify an overall declining trend in veterinary medicine marketing authorisations.
While between May 2024 and 2025 the industry registered a net negative balance of 389 market authorisations – the first in more than 20 years – in the same period from 2025-26 there was a net positive balance of 576 authorisations.
Access VetMed chair Xavier Molins said: “We are not seeing an overall decline in marketing authorisations today, but we are seeing a sustained increase in the resources and costs required to maintain veterinary medicines on the market. That matters for the future.
“Every additional regulatory cost must be considered when companies decide whether to maintain, develop or launch a medicine, and the impact can be particularly significant for SMEs and smaller markets.”
He added: “Europe needs regulation that guarantees the highest standards of quality, safety and efficacy, while also being proportionate, efficient and economically sustainable. Reducing unnecessary burden is ultimately part of safeguarding access to veterinary medicines.”