Your Category: Policy and Regulation

Irish Presidency of the EU in 2026

Why Rare Diseases Matter for Europe’s Future Embedding Research and Innovation as Standard of Care in Rare Disease

October 2 @ 10:00 am - 5:15 pm
On 13 November 2026 in Dublin, Ireland, this event will explore how research, innovation, patient partnership and EU policy can improve rare disease care and strengthen Europe’s life sciences ecosystem.
European Medicines Agency (EMA)

EMA launches a new pilot to advance innovative methods to animal testing

The voluntary data submission framework allows developers to share data generated using New Approach Methodologies outside marketing authorisation applications and receive tailored, non-binding feedback from European regulatory experts.
Conference "Advancement of Treatments for Rare Diseases" in Cyprus, June 2026

Cyprus conference connects European research priorities with the path to rare disease treatments

At the “Advancement of Treatments for Rare Diseases” conference in Nicosia, European and national policymakers joined clinicians, researchers, regulators, industry representatives and patient advocates to examine how stronger coordination can translate scientific progress into better prevention, diagnosis, treatment and access to care for people living with rare diseases.
ERDERA trainings template

ERDERA launches Ethics & Regulatory webinar series with introductory webinar on ethics across the research continuum

ERDERA’s ethics and regulatory experts are launching a dedicated webinar series to help the rare disease research community navigate two fast-moving areas of biomedical research: Advanced Therapy Medicinal Products (ATMPs) and Artificial Intelligence.
Situating ethics in the research continuum

Introductory webinar: Situating ethics in the research continuum

July 24 @ 3:00 pm - 4:00 pm
This webinar will present a theoretical framework for situating ethics across research activities. The framework will then be brought to life through a relevant case study discussion, giving participants a concrete reference point for the episodes ahead.
EU Flags

European Commission opens call for evidence on future Joint Undertakings

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.
ECRD 2026

ECRD 2026 in Prague strengthens the push for a coordinated EU Action Plan on rare diseases

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.
ERDERA Policy Brief

ERDERA Policy Brief: European Biotech Act

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.
Sveriges riksdag (house of parlament).

Sweden adopts first national strategy for rare health conditions

Sweden has adopted its first national strategy for rare health conditions, aiming to improve coordination, equity and access to care between 2026 and 2030.
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.
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