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Regulatory and Ethics Support

Multidisciplinary expertise on regulatory roadmaps and embedding ethical compliance throughout research to support smooth clinical implementation and patient needs.

ERDERA’s Regulatory and Ethics Support Service helps rare disease researchers and clinical teams navigate the complex requirements that sit between scientific discovery and patient benefit.

Building on experience and models developed in EJP RD and drawing on regulatory experts from academia, industry, patient organisations and public authorities, the service provides early, ongoing advice on regulatory pathways, clinical trial and study design, interactions with agencies, and alignment with ethical and legal standards across Europe.

Working in close collaboration with the Clinical Research Network, the Data Hub, the Methodological Support team, the Ethics Advisory Group and the Regulatory Support Groups, it supports projects, it supports projects funded through ERDERA calls and studies to plan for regulatory-grade data, integrate patient‑centred outcomes, and ensure compliance with GDPR and other requirements.

By embedding this expertise from the outset, the service reduces delays, improves the quality and acceptability of clinical evidence, and strengthens Europe’s capacity to bring safe, effective and ethically robust rare disease diagnostics and therapies to people living with a rare disease.

If this is your first time visiting the IMT, we recommend watching our short introductory tutorial to help you navigate the toolbox and find what you need quickly.

Regulatory and Ethics Support Diagram

Who is it for?

The IMT serves the entire rare disease innovation ecosystem, including:

  • Researchers & clinicians working on rare disease projects
  • SMEs and startups developing new diagnostics, therapeutics, digital tools, or services
  • Consortia preparing proposals or implementing funded collaborative projects

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