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Alira Health

Comprehensive Guide to the Content of Integrated Summaries of Efficacy and Safety (ISE/ISS)

Published on:
April 25, 2023
Written by:
Carlo Stimamiglio, Sofia Puzzi, Eve Ogdon

Content of Integrated Summaries of Efficacy and Safety (ISE/ISS)

Comprehensive Guide

When sponsors prepare an application for the registration of pharmaceuticals for human use, a common technical document (CTD), with organization and content driven by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, must be submitted to the regulatory authorities to facilitate the review process.

The CTD must include the Summaries of Clinical Efficacy and Safety (SCE/SCS), which provide a comprehensive summary of all the safety and efficacy data gathered on a study drug across all clinical trials based on individual and pooled analyses.

Their content is supported by Integrated Summaries of Efficacy (Effectiveness) and Safety (ISE/ISS) which are highly technical documents that require expertise and experience to complete and submit successfully.


Download this comprehensive guide to ISE/ISS content to understand what the summaries must include and the requirements for the electronic submission of clinical data. The guide shares what to consider when submitting to FDA and EMA. 

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