Editing Common Technical Document (section)

==Contents==
The Common Technical Document is divided into five modules:<ref>{{cite journal |last1=Jordan |first1=Debbie |title=An overview of the Common Technical Document (CTD) regulatory dossier |url=https://journal.emwa.org/regulatory-writing-basics/an-overview-of-the-common-technical-document-ctd-regulatory-dossier/article/1693/2047480614z2e000000000207.pdf |journal=Medical Writing |year=2014 |volume=23 |issue=2 |pages=102 |doi=10.1179/2047480614Z.000000000207 |access-date=16 May 2022}}</ref>
# Administrative and prescribing information
# Overview and summary of modules 3 to 5
# Quality (pharmaceutical documentation)
# Preclinical (pharmacology/toxicology)
# Clinical – efficacy and safety (clinical trials)

Detailed subheadings for each module are specified for all jurisdictions.  The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements.<ref>{{Cite web |last=Duplessis |first=Tanya |date=2022-12-12 |title=Introduction to CMC and its Considerations |url=https://www.bioforumgroup.com/cmc-considerations/ |access-date=2024-01-15 |website=Bioforum |language=en-US}}</ref><ref>{{Cite web |last=Research |first=Center for Drug Evaluation and |date=2023-11-14 |title=Investigational New Drug (IND) Application |url=https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application |archive-url=https://web.archive.org/web/20190602195438/https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application |url-status=dead |archive-date=2 June 2019 |access-date=2024-01-15 |website=FDA |language=en}}</ref>