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Category: Policy and Regulation

BMC Medical Ethics

Ethics and regulatory guidance to address the challenges encountered in research on rare diseases in a multinational dimension: the experience of a European funded programme

This BMC Medical Ethics article examines ethics and regulatory guidance across EJP RD-funded rare disease research projects.
Female scientist in protective gear using lab equipment for research.. Photo by ima Miroshnichenko via Pexels (CC0)

Biotech Act II: European Commission opens Call for Evidence on industrial biotechnology and biomanufacturing

The European Commission has opened a Call for Evidence on the upcoming Biotech Act II — with feedback open until 10 June 2026, inviting stakeholders to submit input that will help shape the initiative before a legislative proposal is prepared.
ERDERA First Policy Think Tank meeting

ERDERA Policy Think Tank meets in Paris to advance data and registry policy for rare diseases

Bringing together policy makers, researchers and data experts to align on how registry data can better support rare disease research and evidence‑based policy across Europe.
kitt_ks-lab-2107514_1920

Towards animal-free testing: virtual control groups gain regulatory acceptance

For rare diseases, where research often relies on limited animal models and small development teams, the regulatory acceptance of virtual control groups could help streamline early non‑clinical studies while maintaining a strong focus on patient safety.
Insights frInsights from the ERDERA consultancy service surveyom the ERDERA consultancy service survey

Insights from the ERDERA consultancy service survey

Preliminary results point interest across the rare disease research community, while highlighting underrepresentation of some countries and stakeholders
cover for the ERDERA Strategic Research and Innovation Agenda (2024)

ERDERA Strategic Research and Innovation Agenda

The SRIA sets ERDERA’s objectives and performance indicators to guide rare disease research and innovation across Europe.
Nationale Aktionsplan für seltene Erkrankungen

National Action Plan for Rare Diseases in Austria

Austria’s national strategy defining priority areas and concrete measures to improve care, research, and access to services for people living with rare diseases.

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