For most new medicines, developing for adults is only part of the obligation. The Paediatric Investigation Plan determines what a company must do for children — and getting it wrong delays the entire programme.
The Paediatric Regulation (EC) No 1901/2006 requires that, for most new marketing authorisation applications and for certain line extensions of patent-protected products, a company either completes an agreed Paediatric Investigation Plan (PIP) or obtains a waiver or deferral.
PIP, waiver or deferral?
- A PIP sets out the studies needed to support use in children.
- A waiver applies where the disease does not occur in children, or where the medicine is likely to be unsafe, ineffective or of no therapeutic benefit to them.
- A deferral allows paediatric studies to begin later — typically after adult data — so that adult authorisation is not held up.
The Paediatric Committee (PDCO) at the EMA agrees and modifies PIPs, grants waivers and deferrals, and checks compliance.
The rewards
Completing an agreed PIP can earn a six-month extension of the supplementary protection certificate. For orphan medicines, the reward is instead two additional years of market exclusivity. A dedicated Paediatric Use Marketing Authorisation route exists for developing off-patent products specifically for children.
Reform is coming
The EU pharmaceutical legislation reform, which reached political agreement in December 2025, is set to change paediatric development: earlier PIP submission, a more flexible stepwise plan that develops as evidence accrues, and a move toward obligations tied to a medicine’s mechanism of action — potentially narrowing some class waivers. The final text is not yet in force, so plan for the direction rather than the detail.
How PQRA helps
PQRA supports PIP strategy, PDCO interactions, waiver and deferral requests, and compliance across the paediatric lifecycle.
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