Spring Intro 2023

30/03/2023

Neil

Paediatric Development & PIPs

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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What, Why and When ?

What ? • A regulatory authority agreed, defined P aediatric I nvestigation P lan (PIP) is required in the EU. • An equivalent plan is also required in the US under FDA requirements ( P aediatric S ubmission P lan – PSP) Why ? • Improve healthcare for children (increase investigation and authorised medicines) • It is a mandatory regulatory requirement – without one you cannot file an MAA • If you complete development in accordance with an agreed PIP : • 6 months extension to supplementary protection certificate • 2 year extension to data protection for an orphan drug When ? • …….except in duly justified cases, not later than upon completion of the human pharmacokinetic studies in adults. • Following Proof of Concept (Phase II in patients) and in advance of pivotal Phase 3 trials

The Organisation for Professionals in Regulatory Affairs

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