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EU Paediatric Regulation Report ‘Positive,’ But More Investigation Needed, Legal Expert Claims

Executive Summary

The new EU report on how the Paediatric Regulation is working after 10 years is a “positive step forward,” says a legal expert, who also wants the commission to use its postponement of any future legislative changes as an opportunity to further examine – and discuss with all stakeholders – how to improve the procedure concerning pediatric investigation plans. The expert also raises concerns about some of the figures cited in the report.

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