The EMA will introduce an extension to the IRIS platform by onboarding the paediatrics processes in June 2024. Applicants will be able to submit and manage their application and related documents through this platform.
From June 4th, 2024, the following types of paediatric submissions must be performed via IRIS:
- Initial Paediatric Investigation Plan (PIP)
- Modification of an agreed PIP
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Confirmation of Applicability of a class waiver, or of inclusion of an indication within a condition
- Discontinuation of Paediatric Development
This platform will enable quicker interaction between applicants and EMA, as well as improve data quality through integration with other EMA systems. Users will also be able to monitor the status of their paediatric applications from any device and receive automatic updates on the status of their submissions.
Check out the IRIS platform and familiarize yourself with its features before June 4th, 2024: IRIS
Need help for IRIS or other Regulatory endeavours? Contact us at: [email protected]
