The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the preparation and submission of paediatric applications under the Paediatric Regulation (Regulation (EC) No 1901/2006). It provides a comprehensive overview of the procedural steps and requirements for obtaining paediatric investigation plans (PIPs), waivers, deferrals, and marketing authorizations.
The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately; and to 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.
Regulatory & Scientific Information Management Platform (IRIS portal) is a secure online portal for submitting applications for:
Initial paediatric investigation plan (PIP) including responses to PDCO requests for modifications (if applicable)
Modification of paediatric investigation plan (modification of an agreed PIP)
Product-specific waiver
Compliance check
Annual report on paediatric deferred measures
Confirmation requests
Discontinuation of paediatric development.
To avoid a delay in submitting their regulatory submission, applicants should consult the Submission deadlines for paediatric applications 2024-2026 (europa.eu) timetable. In addition, it is important to remember that a PIP compliance check must be performed before marketing authorization/variation/extension can be granted.
All types of paediatric applications must be submitted using the IRIS portal. Follow the IRIS guide for applicants, step-by-step, under Paediatric medicines development, and also refer to the following chapters in this guide for information on the content and format of documents for submitting and receiving.
Applicants for all paediatric applications should use the IRIS portal and follow the IRIS guide for applicants, step-by-step, under Paediatric medicines development, as well as the chapters in this guide for information on the content and format of required documents.
The Paediatric Regulation provides various incentives to encourage the development of paediatric medicines, including extensions of the supplementary protection certificate (SPC) and access to the EMA's free scientific advice.
By following the outlined procedures and requirements, companies can ensure compliance with the Paediatric Regulation and contribute to the availability of safe and effective medicines for children.
For more detailed information, refer to the full document: Procedural Advice on Paediatric Applications.
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