EMA’s Paediatric Medicines Office has recently issued new or updated templates to be followed in the development of Paediatric Investigation Plans (PIPs). These templates must follow the following submission deadlines:
- By 11 August 2025 – Use of the new templates is preferable
- By 8 September 2025 – Use of the new templates is mandatory
Two templates have been updated; the template for scientific document has been revised, including now full sections for PDCO and EMA discussion, requests for supplementary information, and opinion. A new Key Elements Form (KEF) template is now available, which will have to be submitted in Word format in PIP applications –only a high-level in IRIS is necessary now.
In addition, two new templates have been issued to support a more consistent guided approach:
1) One new template for the Applicant’s response to PDCO request for supplementary information (RSI) and modification of proposed PIP following clock-stop.
2) One new template for submission of additional information requested to the Applicant following PDCO discussions.
You can check the new guidelines here: https://bit.ly/45id4J7
For further assistance in the development of your products, contact us at: [email protected]
