Module232025

07/05/2025

Modification of an agreed PIP

● 60-day procedure ● When changes affect the PDCO PIP decision (the binding document)!

The Organisation for Professionals in Regulatory Affairs

37

Modifications

May NOT r equire a PIP modification:

These changes do require a PIP modification:

Additional endpoints Additional statistical analyses More patients included (unless range is given) Imbalance in recruitment within a given age group (e.g. group 1 to 5 years, but most or all children are age 4 to 5) unless balance/min. number is required New, additional non-clinical or clinical studies which are not included in a PIP

Change of primary or secondary endpoint Deletion of a non-clinical or clinical study, or replacement with a different study in a PIP Reduction in total number of patients Stopping for futility/efficacy (if not in the PIP key elements) Delay in the timelines

The Organisation for Professionals in Regulatory Affairs

38