EMA Guidance: Procedural Advice on Paediatric Applications
- Sharan Murugan
- Jul 31
- 2 min read
On 25 July 2025, the European Medicines Agency (EMA) published the latest guidance "Procedural Advice on Paediatric Applications". This updated guidance (EMA/672643/2017 Rev. 131) is a practical roadmap for pharmaceutical companies and applicants preparing paediatric investigation plans (PIPs), waivers, compliance checks, and related regulatory submissions.
The guidance supports the implementation of the Paediatric Regulation:
Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006
Aims to ensure children (from birth up to but not including 18 years) benefit from medicines that are ethically researched, high quality, and authorised for paediatric use.
Applicants must include in their marketing authorisation applications:
Results of studies under an agreed PIP
A waiver decision (product-specific or class)
Or evidence of a deferral, where paediatric studies are planned later
This requirement applies unless the product falls under certain exemptions (e.g., generics, hybrids, biosimilars, or well-established use products).
Before submission: Advice and Planning
The guidance encourages:
✅ Early dialogue with EMA’s Paediatric Medicines Office
✅ Using the IRIS portal to manage submissions
✅ Consulting the IRIS guide for applicants
Sponsors can request pre-submission scientific and regulatory advice by contacting EMA at least two months before the planned submission.
Application types and timelines
Applicants typically submit through EMA’s secure IRIS portal:
Initial PIPs
Modifications of an agreed PIP
Waivers (product-specific or confirmation of class waiver applicability)
Compliance check requests
Annual reports on deferrals
Notifications on discontinuation of paediatric development
Requests for confirmation of condition vs indication
PIPs should be submitted early—ideally before pivotal phase III adult trials—to enable meaningful paediatric research.
For initial PIPs:
Scientific document (using EMA template)
Key element form (summarises main study design points)
Pre-submission meeting minutes (if held)
Supporting documents: SmPC, risk management plan, literature references, etc.
For modifications or waivers, specific templates must be used.
A compliance check ensures an applicant has met obligations under an agreed PIP before marketing authorisation is granted.
Applicants can:
Respond to RSI (within recommended three months)
Request an oral explanation meeting
Ask for re-examination of the PDCO opinion within 30 days
Final EMA decisions are issued within 10 days of the PDCO’s definitive opinion and published on the EMA website.
The guidance also explains:
How to discontinue paediatric development (notification required)
Annual reports on deferred measures
Placing paediatric indications on the market within two years of authorisation
Changing the PIP holder or contact details
For a detailed, step-by-step breakdown of required documents and procedural tips, consult the full guidance document: Procedural advice on paediatric applications
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