Feedback is open until 14 July 2026, giving stakeholders an early opportunity to comment during the preparation of a likely legislative proposal for a Council regulation.
On 3–4 June, EURORDIS–Rare Diseases Europe and Orphanet convened the rare disease community at ECRD 2026 in Prague around a shared call for coordinated European action, including the forthcoming European Blueprint for Rare Diseases.
The European Rare Diseases Research Alliance (ERDERA), together with the European Reference Networks (ERNs), provides the missing operational layer required to implement the European Biotech Act across the full innovation pathway —from discovery to patient access.
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.
Public and patient involvement (PPI) has been identified as an increasingly desired and, often, required component of trial methodology–leading to higher quality, more accessible and relevant clinical research.
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.
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.
