On 13 June 2022, the European Medicines Agency (EMA), unveiled its ‘European Veterinary Big Data Strategy 2022 – 2027’. The strategy seeks to fuse emerging big data technologies with European regulatory frameworks.
In their strategy document, the EMA indicate:
“This…strategy proposes an overview of the vision and direction that the Veterinary EU Regulatory Network should follow in setting a data framework on how veterinary data…should be managed to support key regulatory activities in a short, medium and a long term [sic] phase, ensuring efficient and timely development of the respective regulatory use cases in specific veterinary regulatory areas”.
According to the EMA, their goals include:
“Increasing interoperability across regulatory systems that shall be operated by an optimized set of scientific resources, to reduce administrative and economic burden and enhance consistency, transparency and responsiveness within the Agency”.
The EMA estimate that the strategy will be implemented across a 5 to 7 year timeline divided into three phases: short, medium, and long-term.
The short-term phase involves, “building the data framework and identify[ing] new suitable data sources”. It is expected this phase will last 1 to 2 years.
The medium-term phase, spanning 2 to 5 years, focuses on “integration of the collected data with the focal areas to support the identified business cases and realise related regulatory benefits”. The EMA has identified many such business-use cases in an annex to the strategy document, including pharmacovigilance, efficacy and safety demonstration, and coordination of GxP inspections.
Finally, the long-term phase will comprise solidifying and expanding ‘analytic capabilities’, ‘data connection’ and ‘information dissemination’.
In an accompanying media release, the EMA summarise:
“The strategy sets up a framework for managing and using…data to support key regulatory activities. This will enhance consistency, transparency and responsiveness across the network by providing accurate and reliable information”.
Emerging technologies have the capacity to fundamentally alter how stakeholders engage with, and are serviced by international regulators. As such, it is important to recognise and plan for technology’s ever-evolving role in shaping commercial and regulatory realities.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com, or call +61 422 909 125 for more information.
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