Module232025

12/05/2025

Agreed PIPs & Waivers by PDCO, July 2007-February 2025

1.6%

Initials PIPs # 1966

Full waivers # 1267

38.5%

Initial PIPs Full Waivers Negative Opinions

59.8%

Negative opinions # 54

Initial PIPs and Waivers withdrawn: ~20%

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NEW VERSION

Scientific document - new version mandatory from March 2024

New features Graphs for development Leaner structure overall Focus on NEW Key Elements

New aspects reflected Embed extrapolation Updated M&S section Feed-back from other regulators*/ let us know if you submitted also to FDA

Fully revised formulation and non-clinical sections Facilitates assessment and input form WPs WGs

More rational Waiver section Commenting streamlined

Input received from experts

12 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-procedures * https://ascopubs.org/doi/10.1200/JCO.20.02152?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed/ https://link.springer.com/article/10.1007/s43441-021-00339-z / eg https://www.ema.europa.eu/en/documents/other/common-commentary-emafda-common-issues-requested-discussion-respective-agency-emapdco-and-fda-concerning-paediatric-oncology-development-plans-paediatric-investigation-plans-pips-and-initial-pediatric_en.pdf

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