Module232025

07/05/2025

Discontinuation of paediatric development

Own experience: Product withdrawn from market - modification request submitted to PDCO, who agreed: • That there was no longer an unmet need in the paediatric population • Thus, outstanding measures in PIP were deleted.

The Organisation for Professionals in Regulatory Affairs

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Stepwise PIP (sPIP) pilot

EMA runs a pilot to test a 'stepwise PIP' agreement for a partial development programme supporting the authorisation of innovative medicinesfor children Guidance for Stepwise PIP pilot - European Medicines Agency |

The sPIP will then be complemented through subsequent planned PIP modifications, based on milestones/timelines for the submission of PIP modifications. Agreed with the PDCO at the time of the initial PIP assessment. “Updated timelines/milestones can be agreed during the modification procedure with the PDCO for the subsequent PIP modifications”.

The Organisation for Professionals in Regulatory Affairs

46