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The Need for Juvenile Animal Studies in EU Paediatric Plans: When and Why?

This article was originally published in SRA

Executive Summary

With the advent of the European Union Paediatric Regulation (No 1901/20061) requiring the submission of a paediatric investigation plan and establishing a Paediatric Committee (PDCO) within the European Medicines Agency, juvenile animal testing has become a critical planning issue for many early development projects. This is due to concerns at several levels: a timing mismatch between the Paediatric Regulation and nonclinical guidelines; a lack of transparency in PDCO decisions on nonclinical measures, including an apparent drift from case-by-case testing to general screening; and an uncertainty as to the use of nonclinical data in the regulatory context.

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