Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process.

ABSTRACT:

Background

Conducting clinical trials (CTs) with children presents several challenges. A major challenge is the need to enrol participants at multiple sites across different jurisdictions. Regardless of whether the trials involve children, adults, or both, CTs need to meet separate Competent Authority (CA) requirements to proceed in each participating country. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the regulatory requirements including any specific to pediatrics, as well as current or upcoming changes across six jurisdictions-the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia.

M

SUBMITTER: Stewart B 

PROVIDER: S-EPMC12037545 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature