Tag: 2025

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

16 February 2026

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.

EU institutions agree next steps on reform of pharmaceutical legislation

3 February 2026

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.

ICH E22 Guideline on general considerations for patient preference studies

2 January 2026

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.

ERDERA Open Session: science and advocacy align to advance rare disease research and care

30 October 2025

Amsterdam and online, convening clinicians, scientists and advocates to share progress and the power of patient led policy to improve diagnosis and care.

ERDERA at WODC Europe 2025: wrap up and next steps

29 October 2025

Sharing patient‑centred methods, early diagnostics, and data‑driven trial innovation to accelerate rare disease research across Europe.

EMA reflection paper on Patient Experience Data (PED)

16 September 2025

First published on 29 September, this EMA reflection paper encourages early dialogue with regulators on how patient experience data can strengthen evidence packages in medicines development and marketing authorisation.