Module232025

07/05/2025

How to prepare a PIP • Consider PIP pre-submission meeting – for validation • PIP must be a stand-alone document – well-written ~ 50-60 pages

• EMA Word template for scientific-document • With instructions – IMPORTANT to follow green guidance text!!!

• EU Commission guideline on the format and content of PIP applications • EMA follows the guideline closely, already at validation

• Follow the Procedural advice on paediatric applications, submit via IRIS

The Organisation for Professionals in Regulatory Affairs

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Overall structure of a PIP application

Application Form (In IRIS)

IRIS : Product and Regulatory Information

Section 1 : Application Summary. Section 2: Targeted conditions/indications, general pharmacology of drug, paediatric medical needs by age groups (with prevalence) and potential therapeutic benefit of drug versus alternatives. Section 3 : Waiver request per age group. Section 4 : Summary of existing data on drug and details of the proposed paediatric development for the drug: quality, pre-clinical and clinical. Timelines of the individual studies. Section 5 : Deferral request.

Scientific document (Word document, free format)

Supporting documents : Annexes (IB, literature etc)

Key elements form : concise proposal of quality, pre-clinical and clinical studies.

Key Element Form (in IRIS)

The Organisation for Professionals in Regulatory Affairs

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