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ERDERA clinical trial call

Press Release | ERDERA Clinical Trial Call

ERDERA launches Clinical Trial Call 2026 to advance early‑phase clinical trials for rare diseases
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.
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EMA launches consultation on proof-of-concept data in paediatric oncology

This initiative is also highly relevant from a rare diseases perspective, as paediatric cancers are rare conditions where small patient populations make robust non‑clinical proof‑of‑concept data essential for responsible and ethical trial initiation.
Factsheet – How the European Commission works on Rare Diseases and the European Reference Networks (ERNs)

Factsheet – How the European Commission works on Rare Diseases and the European Reference Networks (ERNs)

Overview of the European Commission’s coordinated approach to rare diseases, including policy, research, and the role of European Reference Networks.
Factsheet - EU delivering on rare diseases for patients and families

Factsheet – EU delivering on rare diseases for patients and families

Overview of how the European Union supports patients with rare diseases through coordinated policy, research, and healthcare collaboration.
European Parliament

European Parliament draft report urges a binding EU rare disease action framework

A legislative own initiative file in the Parliament’s new public health committee sets out what an EU “rare disease action framework” could look like — and why it could change how Europe measures progress for patients.
Publicaciones (1)

EU rare disease action plan- European Added Value Assessment

This study investigates possible measures that could be taken at EU level to address these challenges. It finds significant European added value in harmonising coordination and access across the 27 Member States, mainly in terms of improved diagnostic tools and availability of medical treatment, better health outcomes, particularly lower infant mortality, and improved well-being of family members and caregivers.
Scientific paper

Human genomics technologies in clinical studies – the research landscape: report on the 1990–2024 period

Published on 14 December, this WHO technical document maps global trends in registered clinical studies using human genomic technologies from 1990 to 2024, including patterns of inclusion and equity.
Pharmaceutical products

EU institutions agree next steps on reform of pharmaceutical legislation

Following the 11 December 2025 political agreement, EU institutions are moving towards formal adoption of a new Directive and Regulation that will reshape how medicines—including orphan and paediatric medicines—are developed, authorised and supplied across the European Union.
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ICH E22 Guideline on general considerations for patient preference studies

Open for consultation from 12 December to 12 April, this draft ICH guideline sets out how to design and submit robust patient preference studies to inform regulatory decision‑making across a medicine’s lifecycle.
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