CRED Understanding Clinical Development 2024

08/10/2024

PIP scope – the “PIP condition”

• Be careful not to confuse “PIP condition” with “PIP indication” and “therapeutic indication”

• “PIP indication” = a specific diagnosis in which a PIP -mandated study will be performed

• “Therapeutic indication” = a claimed indication for Section 4.1 of the SmPC

The PIP condition must encompass all PIP indications and intended therapeutic indications for adults as well as children

The Organisation for Professionals in Regulatory Affairs

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PIP content

Application form:

•

• Long and detailed; now completed on-line

Parts 1-5:

•

• Background information plus details of and justifications for the paediatric development proposals

Key Elements Form (KEF):

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• A summary of the paediatric development commitments; now completed on-line

Annexes:

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• Bibliography, IB, scientific advice letters, orphan designations etc

Use EMA’s templates and do not alter their structure

The Organisation for Professionals in Regulatory Affairs

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