European Medicines Regulatory Network opens draft data strategy for public consultation

The European Medicines Regulatory Network (EMRN)’s draft strategy focuses on enhancing regulatory data quality, interoperability, and utilization.

The EMRN has published its draft data strategy, inviting public consultation until December 31, 2024. This initiative aims to address the increasing volume and complexity of data in medicines regulation by establishing a coordinated approach to data management and utilization.

The draft, titled, ‘European Medicines Agencies Network Data Strategy: Increasing the Value of Data for the Benefit of Public and Animal Health’, aims to establish, “a comprehensive framework to maximize the value of regulatory data while ensuring its quality, security, and ethical use.” The framework aligns with the broader objectives of the draft European Medicines Agencies Network Strategy to 2028, focusing on advancing data-driven decision-making and strengthening the network's digital capabilities.

Addressing key challenges

The draft identifies several challenges within the EMRN's current data landscape, including, “different operational approaches, data fragmentation, inconsistent quality levels, and underutilization of advanced analytics.” It also highlights issues such as, “varying levels of organizational maturity, skills, and technical readiness across the network,” as well as financial constraints that limit the pace of implementing and uniformly adopting data management improvements.

To address these issues, the strategy emphasizes the importance of enhancing data quality, integration, interoperability, and accessibility. It states:

“Getting the full value from the data requires the data to be of good quality, well documented, and accessible for possible consumers of the data.”

The draft also highlights the potential of new technologies, noting that, “new technologies, standardisation initiatives like ISO IDMP and controlled terminologies offer new ways of getting value from data, either for well-known purposes or for entirely new ones.”

The strategy was co-developed by the Big Data Steering Group and the European Network Data Board, highlighting the need for collaboration across the network to address challenges arising from the increasing volume and complexity of regulatory data.

Data principles and strategic objectives

The draft strategy identifies six guiding data principles and outlines specific objectives to translate these principles into actionable steps. Together, they form the foundation for achieving the EMRN’s vision of a data-driven regulatory network.

Data principles:

1. Data are an asset: Data must be managed and governed as a valuable resource.
2. Data are accessible: Data should be findable and usable across functions and stakeholders.
3. Data are shared: Interoperable data facilitates efficient regulatory processes and benefits public health.
4. Data are managed: Defined roles and governance ensure accountability for data quality and lifecycle.
5. Common vocabulary and definitions: Consistent terminology promotes seamless interoperability.
6. Data are safe and secure: Robust safeguards protect data from unauthorized access or misuse.

The strategy also emphasizes ethical data use, with principles like transparency, fairness, and sustainability underpinning all activities. Ethical frameworks ensure that data is used responsibly while protecting individual and societal interests.

To maximize the value of the data managed by the EMRN, strategic objectives include:

1. Data governance: Establish a unified governance framework aligned with EU interoperability initiatives, such as the European Health Data Space (EHDS) and EU Interoperable Framework, to enable seamless integration and standardization across systems.
2. Data quality management: Embed proactive quality controls into all data systems to ensure data reliability, trustworthiness, and relevance.
3. Interoperability: Enhance data sharing and integration by adopting international standards and master data management, enabling seamless data exchange and reducing fragmentation.
4. Data cataloguing and metadata management: Improve data discoverability and usability through standardized frameworks, enabling efficient access and supporting collaboration.
5. Knowledge and change management: Build capacity and readiness for emerging EU data regulations, ensuring that stakeholders across the network have the necessary skills and tools to leverage data effectively.
6. Value generation through analytics: Use advanced tools, including AI and data visualization technologies, to extract insights from structured and unstructured data, driving innovation and evidence-based decision-making.

These objectives aim to translate the data principles into actionable steps, establishing a comprehensive, data-driven regulatory framework designed to improve public and animal health outcomes while promoting collaboration and innovation.

Public engagement

The European Medicines Agency (EMA) is inviting stakeholders from across the healthcare ecosystem, including regulators, industry representatives, and public health organizations, to participate in the consultation process. The EMA notes that input from this consultation will refine the strategy to better align with the needs of its diverse stakeholders.

The draft also aims to future-proof the network’s data approach, ensuring adaptability to emerging technologies and trends. By doing so, it seeks to build a robust regulatory framework capable of leveraging data for enhanced public and animal health outcomes.

Feedback can be submitted through the EMA’s public consultation platform until the end of 2024.