Regulatory Operations: eCTD and Submissions news

NEWS | EMA to launch paediatric submissions on IRIS platform

The launch will bring several benefits, such as enabling quicker interaction between applicants and EMA, and improving data quality through integration with other EMA systems. Furthermore, the IRIS platform will allow applicants to monitor the status of their paediatric applications from any device and receive automatic updates on the status of their submissions. These features will significantly enhance the transparency and efficiency of the paediatric application process.  

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