Veterinary big data

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are jointly running a multi-year veterinary big data initiative, to help the European medicines regulatory network move towards a more data-driven culture in the regulation of veterinary medicines in the European Union (EU). 

Updated on 10 July 2024
'Veterinary big data strategy and workplan' section
'Implementation phases' section

EMA, national competent authorities and pharmaceutical companies use digital systems in the regulation of veterinary medicines in the EU. These systems gather, process and make available crucial data for the regulation of veterinary medicines. Some of these serve to implement the Veterinary Medicinal Products Regulation in force since January 2022, including the Union Product Database.

Meanwhile, animal health professionals and users of veterinary medicines increasingly use digital technologies and tools in farm management and animal healthcare practices, which also generate large amounts of real-world data. This reflects a general societal trend, whereby massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation.

More information:

• Veterinary Medicinal Products Regulation
• Union Product Database
• Big data

Veterinary big data strategy and workplan

The joint EMA/HMA veterinary big data strategy sets out how the European medicines regulatory network intends to make use of new digital technologies and preparing for future changes in the realm of big data.

The strategy involves:

• Building the data ecosystem (technology and data) necessary to support data-driven decisions in the regulation of veterinary medicines;
• Increasing system interoperability and re-usability of data in different regulatory areas and product lifecycle stages;
• Reducing administrative burden for medicine developers and marketing authorisation holders;
• Ensuring data quality, consistency and connectedness across the European medicines regulatory network;
• Evaluating the potential benefits of innovative technologies;
• Defining the new European medicines regulatory network data strategy, including its vision, data principles and objectives.

It covers the following regulatory topics

• Union Product Database
• Pharmacovigilance (veterinary medicines)
• Antimicrobial Sales and Use Platform
• Environmental risk assessment of veterinary medicines
• Regulatory submission and evaluation
• Manufacturing / inspections coordination
• Innovative use of digital technologies

The strategy also includes the evaluation of the impact of upcoming legislation on the veterinary data landscape, including the Interoperable Europe act

EU veterinary big data workplan sets out the key milestones and timelines for the veterinary big data initiative from 2023 to 2025.

EMA and the Heads of Medicines (HMA) endorsed the workplan in May 2023.

European veterinary big data strategy 2022-2027

Reference Number: EMA/648865/2021

EU veterinary big data workplan to 2025

Implementation phases

The European medicines regulatory network plans to implement the veterinary big data strategy in three main phases between 2021 and 2027:

Implementation phases - text version

Collection:

• Data Quality Framework
• EU Veterinary Data Hub
• New data sources

Integration:

• Data integration
• Reports and methodologies
• Analytic inception

Connection:

• Exploit data connection
• Information dissemination
• Data catalogue

Data collection

The short-term data collection phase involves the following activities:

• Gathering complete medicinal product data in the Union Product Database (UPD) established under the Veterinary Medicinal Products Regulation.
• Enabling system integration, whereby UPD data feed into other systems used by EMA and veterinary medicine regulators, such as EudraVigilance Veterinary.
• Mapping and identifying other sources of data and real-world evidence that may support the regulation of veterinary medicines in the EU.
• Establishing a network of experts, known as the EU Veterinary Data Hub, to provide expertise in data management and analysis in the veterinary medicines field.
• Defining the target operating model and developing the product roadmap for veterinary big data and data analytics initiatives.

This phase began in 2021 and is expected to run until 2023 or beyond.

Data integration

The medium-term data integration phase involves integrating data into key regulatory areas and procedures, such as:

• medicine information management (e.g. on supply shortages);
• pharmacovigilance;
• antimicrobials.

It also involves preparing tools and methods for data analysis and data-driven processes with the support of target users.

This phase is expected to run from 2023 to 2025 or beyond.

Data connection

The long-term data connection phase involves developing and enhancing analytical tools and exploiting data-connectedness in key regulatory areas. It is set to involve the use of new technical solutions, data sources and real-world evidence.

The main ambition of this phase is to help establish data-driven practices in the regulatory field based on real-world evidence.

It is expected to run from 2025 to 2027.

Data literacy programme and EU Veterinary Data Hub

Promoting a data culture within the European medicines regulatory network prepares it to respond to an increasingly complex digital environment.

EMA is responsible for two related initiatives:

• Data literacy programme - an initiative aimed at developing the expertise necessary to address data-related requests in an effective manner.
• EU Veterinary Data Hub - a network of multidisciplinary experts building the methods to respond to data analysis requests.

The Veterinary Data Hub includes experts from Belgium, France, Germany, Portugal, Spain and Sweden. It was established in June 2023.

Stakeholder engagement

Thestakeholders standing to benefit from the strategy include:

• veterinary pharmaceutical industry;
• animal health professionals;
• farm and companion animal health-system providers;
• academics;
• EU agencies and institutions;
• global regulatory bodies.

EMA and HMA organise veterinary big data stakeholder forums each year for all interested parties. These aim to build awareness of the use of innovative digital technologies in the regulation of veterinary medicines, and to discuss progress in implementing the veterinary big data strategy.

More information:

• Fourth Veterinary Big Data stakeholder forum (14/10/2024)
• Third Veterinary Big Data stakeholder forum (23/11/2023)
• Second Veterinary Big Data stakeholder forum (23/11/2022)
• First Veterinary Big Data stakeholder forum (01-02/06/2021)

EMA's quarterly Veterinary Medicines Highlights newsletter contains a round-up of latest developments in the field of veterinary big data:

• Veterinary Medicines Highlights

To receive the newsletter by email, please send an email to [e-mail].