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

 
• By Neena Brizmohun

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.

Vaccination
Legal expert calls for more investigation into how to improve the PIP procedure

The European Commission’s report on how the controversial Paediatric Regulation is working 10 years after it came into force is “a positive step forward,” but it also highlights the need to review how the procedure relating to pediatric investigation plans (PIPs) is functioning, according to a legal expert.

“The report is fairly balanced, makes sensible observations, and the commission concludes on a positive socio-economic value of the Paediatric Regulation,” Geneviève Michaux, a partner at the law firm Mayer Brown, told the Pink Sheet

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