Big Data strategy for veterinary medicines in the EU
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a Veterinary Big Data strategy to 2027 outlining their vision for fostering data-driven, digital innovations in the veterinary medicines’ domain in the European Union (EU).
Building upon key objectives of the recently implemented Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), the strategy aims to converge traditional regulatory practice with innovative digital solutions. The strategy proposes to identify relevant use cases, existing and additional data sources, critical infrastructure and methods to enable an environment that encourages innovation in the development of new veterinary medicines for the benefit of animal and human health and welfare.
As part of the implementation of the veterinary legislation, EMA and the whole EU veterinary medicines regulatory network have made significant investments to implement new IT systems that generate and centrally collect increased amounts of data. The strategy sets up a framework for managing and using these data to support key regulatory activities. This will enhance consistency, transparency and responsiveness across the network by providing accurate and reliable information to promote public and animal health.
The Veterinary Big Data strategy proposes implementation in phases:
- Up to 2023: strengthen collection of key data and identification of additional data sources to better support regulatory activities in subsequent implementation phases
- 2023-2025: integrate key data in targeted regulatory processes and start analytics solutions
- 2024-2027: connect data to power information sharing and dissemination and expand analytic capabilities. This phase will be aligned with the Big Data strategy for human medicines.
The new strategy impacts different business areas, such as pharmacovigilance, the fight against antimicrobial resistance (AMR), environmental risk assessment, regulatory submission, innovation of veterinary medicinal products development and demonstration of efficacy/effectiveness.
A first veterinary big data stakeholder forum bringing together regulators, the pharmaceutical industry, farm management system providers, academia, consumers and practitioners, took place in June 2021. A follow-up forum will be held on 23 November 2022.