Pediatric submissions aim to fill this knowledge gap and ensure that medications used in pediatric patients are appropriately tested, dosed, and labeled.
This guidance aims to ensure that pharmaceutical companies generate high-quality data on the safety, efficacy, and appropriate dosing of medications for children.
Key Elements of Pediatric Submissions
Pediatric Investigation Plans (PIPs)
Study Design Considerations
Data Collection and Analysis
Labeling and Pediatric Use Information
A Pediatric Investigation Plan (PIP) is a regulatory requirement in the European Union (EU) that mandates pharmaceutical companies to provide a comprehensive plan for the study of their drug in the pediatric population.
To facilitate the submission of pediatric data, the EMA implemented the Syncplicity Web Client, a secure file-sharing platform that enables efficient collaboration and exchange of information between the regulatory authorities and pharmaceutical companies.
This web-based tool ensures the secure transmission of sensitive data while streamlining the submission process, minimizing delays, and enhancing transparency.
Click this LINK to know more about the list of required documents by procedure types.