What You Need to Know About Pediatric Plan Requirements

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PEDIATRIC PLANS ARE A REQUIREMENT FOR ALL NEW MEDICINES

Pediatric plans are a requirement for ALL new medicines that are not on the waiver list or exempted, and not just those that are identified as available for children. PIPs are the EU Pediatric Regulation’s main tool to ensure that previously unmet therapeutic needs in children are researched and appropriate medicines are developed. PSPs are required by the FDA in the U.S. to identify needed pediatric studies early in drug development.

The rules support specific, stringent requirements related to pediatric plans, including when and how PIPs and PSPs are filed. Not filing them properly or on time could prevent Marketing Authorization Applications (MAAs) and New Drug Applications (NDAs) from being evaluated.

Download our updated Pediatric Clinical Trials: The Need for Regulation (Part 1) for insights you need to know about the evolution of pediatric trials and how pediatric plan requirements will impact your clinical development. 

At Synteract, we’ve executed more than 3,700 Phase I-IV projects across multiple therapeutic areas in 62 countries on 6 continents. In just the last 5 years, nearly 50 of these have been pediatric trials, across multiple indications.

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