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EMA Procedural Advice: Paediatric Applications – A Comprehensive Guide for Applicants

On 8 August 2025, the European Medicines Agency (EMA) published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric Applications". This guidance is a key reference for pharmaceutical companies developing medicines for children under the Paediatric Regulation (EC) No 1901/2006. It ensures that medicines for paediatric use are developed according to high-quality, ethical, and scientific standards, while aligning with regulatory timelines.


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The guidance applies to all Paediatric Investigation Plans (PIPs), waivers, deferrals, and modifications within the EU.


It supports applicants in preparing and submitting their paediatric development strategies, ensuring the safe and effective use of medicines in children across all age groups. The paediatric population is defined as the population between birth and the age of 18 years (meaning up to but not including 18 years).


The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately; and improve the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.


All applications must be submitted electronically via the EMA IRIS portal. This includes:

  • Initial PIP proposals

  • Waiver requests

  • Deferral requests

  • PIP modifications

  • Compliance checks

Applicants must follow the published EMA submission deadlines to ensure timely review. Applicants should reference the up-to-date submission calendar and prepare submissions well ahead of PDCO meeting dates to avoid delays. Full fee waivers are granted for PIP procedures, but administrative charges may apply for late withdrawals or negative validations. Registered SMEs benefit from additional administrative fee waivers.


EMA validates submissions and notifies the applicant of acceptance or requests for additional information. Successful validation signals the official start of the assessment period. The Paediatric Committee (PDCO) reviews the application and may request supplementary information (RSI). Applicants have three months to respond to RSI, and any changes must be submitted in the specified format.


After review, the PDCO issues an opinion (with possible re-examination rights for the applicant). The final EMA decision follows, transmitted via IRIS and published online.

  • Orphan medicines: Still require PIPs unless a waiver is granted.

  • Conditional marketing authorisations: Must integrate paediatric plans.

  • Global development: EMA encourages harmonisation with other regulators to avoid duplication.


For additional details, downloadable templates, and the authoritative procedural guidance, refer to the official sources:

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