On 15 April 2025, the European Medicines Agency (EMA) released an updated version (Rev. 121) of its procedural advice on paediatric applications (EMA/672643/2017). This revision reflects the agency’s commitment to streamlining regulatory processes, enhancing transparency, and supporting innovation in paediatric medicine development across the EU.
All paediatric-related submissions – must be submitted exclusively via EMA’s IRIS portal. This aims to unify submissions under a single digital platform, improving efficiency and tracking.
- Initial paediatric investigation plan (PIP)
- Modification of paediatric investigation plan
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Discontinuation of paediatric development.
The EMA has introduced simplified templates, removing comment boxes for clearer submissions. These new formats must be used to ensure compliance.
🔹 Clarified Pre-Submission InteractionsApplicants can request pre-submission scientific and regulatory discussions to clarify procedural and content requirements ahead of formal submission.
🔹 Updated Submission CalendarRevised deadlines for paediatric procedures for 2024–2026 have been published. Applicants must plan accordingly to meet EMA timelines.
🔹 Administrative Charges IntroducedWhile paediatric procedures remain free of standard fees, new administrative charges apply in some withdrawal cases. Registered SMEs remain exempt.
This revision strengthens the EU regulatory framework for paediatric medicines by simplifying procedures, encouraging digital transformation, and supporting developers through clearer guidance.
For those navigating the complex world of paediatric regulatory submissions, Masuu offers expert services to guide you through the latest European regulations. Our team of regulatory affairs specialists is here to ensure your paediatric applications meet all EMA requirements, facilitating a smooth and compliant submission process.
For detailed instructions and access to templates, visit the EMA’s official page on paediatric procedures.
Stay informed. Stay compliant. Let Masuu support your journey to regulatory success.