STARS focused on regulatory science training, UNICOM on global medicine identification standards, and Gravitate-Health on medication information standards.
AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN
Dutch national medicines regulatory authority contributing regulatory science, pharmacovigilance, and drug standardisation expertise to EU health consortia.
Their core work
This is the Dutch Medicines Evaluation Board (CBG-MEB), the Netherlands' national regulatory authority responsible for evaluating and approving medicines for the Dutch market. In H2020 projects, they bring regulatory expertise to consortia working on drug safety, pharmacovigilance, medicine identification standards, and neurodegenerative disease research. Their core contribution is bridging the gap between scientific research and regulatory practice — ensuring that project outputs align with real-world medicine approval and safety monitoring requirements. They also contribute to EU-wide efforts on cross-border eHealth infrastructure and standardised drug databases.
What they specialise in
UNICOM addresses pharmacovigilance through standardised drug databases, VAC2VAC covers vaccine quality control, and Gravitate-Health targets medication adherence and risk minimisation.
ROADMAP built a real-world evidence platform for Alzheimer's, RADAR-AD developed remote assessment tools, and EPND is creating a European neurodegenerative disorders data platform.
UNICOM implements IDMP standards for univocal medicine identification across borders, while Gravitate-Health builds digital standards for patient health information.
VAC2VAC focused on consistency-based vaccine lot comparison testing methods.
How they've shifted over time
In their early H2020 participation (2016–2018), the agency focused on real-world evidence generation, health economics, and vaccine quality control — contributing regulatory perspective to clinical and manufacturing research. From 2019 onward, a clear shift occurred toward digital health infrastructure: medicine identification standards (IDMP), cross-border eHealth systems, pharmacovigilance databases, and patient-facing medication management tools. This mirrors the broader EU regulatory push toward digitalisation of medicines data and interoperable health systems.
Moving firmly toward digital health infrastructure and interoperable medicine data standards — a strong partner for any project requiring regulatory authority involvement in eHealth or pharmacovigilance systems.
How they like to work
Exclusively a participant across all 7 projects, never a coordinator — consistent with their role as a regulatory authority contributing domain expertise rather than leading research. They operate in large consortia (156 unique partners across 27 countries), which reflects the nature of EU-wide regulatory harmonisation efforts. Their engagement pattern suggests they are a trusted institutional partner recruited for regulatory credibility and practical knowledge of medicine approval processes.
Extensive pan-European network spanning 156 unique partners across 27 countries, reflecting their involvement in large-scale health and regulatory consortia. Their reach covers nearly all EU member states, consistent with their role in cross-border regulatory harmonisation.
What sets them apart
As a national medicines regulatory authority, CBG-MEB brings something most research organisations cannot: direct regulatory decision-making experience and authority over medicine approvals. This makes them an essential partner for projects that need to demonstrate regulatory relevance or that aim to influence medicine policy. For consortium builders, having a national medicines agency on board adds immediate credibility and ensures project outputs are designed with real regulatory pathways in mind.
Highlights from their portfolio
- UNICOMBy far their largest project (EUR 1.75M) — a flagship EU initiative to implement global medicine identification standards (IDMP) across borders, directly tied to EMA and eHealth Network infrastructure.
- Gravitate-HealthLong-running project (2020–2026) focused on empowering patients with personalised medication information — represents the agency's shift toward citizen-facing digital health.
- EPNDMost recent project (2021–2026) building a European platform for neurodegenerative disorders, showing continued commitment to disease-specific data infrastructure.