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Evaluating the EU Paediatric Regulation

This article was originally published in SRA

Executive Summary

Nearly a year has elapsed since companies seeking marketing authorisations in the European Union were required to begin submitting paediatric investigation plans or requests for waivers/deferrals under the Paediatric Regulation1, and nearly two years have passed since the European Medicines Agency’s Paediatric Committee (PDCO) held its first meeting. In light of the timing, RAJ Pharma decided it was apt to assess the paediatric programme’s success and to learn more about developments that are in the pipeline.

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