Guidance on Paediatric Submissions: Via eSubmission Gateway and eSubmission Web Client

On 19 July 2021 the EMA announced the availability of the guidance on paediatric eSubmssion.

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. Applicants should follow the guidance on paediatric submissions published on the eSubmission\paediatric submissions page.

EMA does not accept submissions that do not follow the published guidance on paediatric submissions, including using the correct submission channel.

Applicants should note that the xml delivery files for paediatric submissions changed in November 2020. An overview of changes is provided in the following presentation, with further information in an updated guidance on paediatric submissions below.

EMA advises applicants new to the eSubmission Gateway to submit their application well in advance of the targeted deadline.

The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main types of paediatric submissions.

This document should be read in conjunction with other relevant guidance on content available on the EMA website, such as the European Commission Guideline on the Format and Content of PIP applications; Paediatric Medicines; Paediatric investigation plans: questions and answers; and the Paediatric Regulation.

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