Usage Examples
- PDCO agreed the PIP with a deferral, so the paediatric studies run after the adult filing.
- We requested a waiver because the indication does not occur in children.
- The MAA cannot move until the PIP compliance check clears.
What is Pediatric Investigation Plan (PIP)?
A Pediatric Investigation Plan is the EU development programme for studying a medicine in children, assessed by EMA's Paediatric Committee. Marketing authorisation applications for new medicines must report results from an agreed PIP unless a waiver or deferral applies.
A Pediatric Investigation Plan exists to stop paediatric evidence being an afterthought. EMA describes the PIP as a development plan aimed at ensuring the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. The Pediatric Investigation Plan turns that intent into leverage: without an agreed plan or an exemption, a new medicine does not reach the EU market.
A Pediatric Investigation Plan covers the paediatric studies for one medicine and the timelines attached to them, plus any request for a waiver or deferral. The PIP is an EU instrument only. It does not discharge the separate US Pediatric Study Plan obligation under 21 U.S.C. 355c(e). Nor is a Pediatric Investigation Plan a trial authorisation. PDCO agreement to a plan is not permission to run it.
A Pediatric Investigation Plan is applied through a compliance check, not on trust. Once the plan is complete, EMA or the national medicines authorities check that companies comply with the agreed measures listed in each PIP, before the applicant can apply for a marketing authorisation or a change to an existing one. Regulatory teams therefore treat the agreed PIP as a filing gate and track every measure to documented completion.
Not to be confused with
- Pediatric Study Plan (PSP)
- the US obligation under 21 U.S.C. 355c(e), filed before the pediatric assessments and agreed in writing with FDA. A PIP agreed by PDCO does nothing for a US filing, and the two are prepared on different clocks.
- PIP waiver
- a waiver is the exemption from paediatric development, granted where development in children is not needed or not appropriate. The PIP is the plan itself; the waiver is permission not to execute one.
- PIP deferral
- a deferral moves timing, not obligation. Even when studies are deferred, the PIP still contains the paediatric studies and their timelines, so the commitments survive the delay.
- Marketing authorisation application (MAA)
- the MAA is the licence application; the PIP is a precondition inside it. The MAA carries the results, while the PIP defines which results are owed.
The obligations split by region. These are the anchors on each side.
What you must do
- 1Include in the marketing authorisation application for a new medicine the results of the studies described in an agreed PIP, unless a deferral or waiver exempts the productEMA, Paediatric investigation plans
- 2Obtain a PDCO opinion on the PIP, deferral, waiver or modification, since the committee formulates the opinion that is notified to the applicantEMA, Paediatric investigation plans
- 3Keep the paediatric studies and their timelines inside the PIP even when PDCO grants a deferralEMA, Paediatric investigation plans
- 4Clear the PIP compliance check by EMA or a national medicines authority before applying for a marketing authorisation or a change to an existing oneEMA, Paediatric investigation plans
- 5For US development, submit the initial pediatric study plan before the pediatric assessments and no later than 60 calendar days after the end-of-Phase 2 meeting21 U.S.C. 355c(e)
Common mistakes
Assuming a US PSP covers the EU, or the reverse
the PSP is agreed with FDA under 21 U.S.C. 355c(e) and the PIP is assessed by PDCO. Running one file for both leaves a region with no agreed plan, and that gap surfaces at filing, when there is no time left to run a paediatric study.
Treating PDCO agreement as the finish line
agreement defines the obligation, it does not discharge it. EMA or a national authority checks compliance with the agreed measures before the marketing authorisation application can proceed, so a measure quietly dropped or changed mid-development blocks the filing.
Reading a deferral as a reprieve from paediatric work
a deferral moves the timing only. The PIP still carries the paediatric studies and their timelines, and those commitments stay enforceable. Teams that drop paediatric planning after a deferral end up rebuilding it under filing pressure.
When This Matters
- PDCO agreed the PIP with a deferral, so the paediatric studies run after the adult filing.
- We requested a waiver because the indication does not occur in children.
- The MAA cannot move until the PIP compliance check clears.
Frequently Asked Questions
Every application for a new medicine does, unless a waiver or deferral exempts it. EMA states that all applications for marketing authorisation for new medicines have to include the results of studies described in an agreed PIP. Compliance with the agreed measures is checked before the application can be filed.
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