Editing Common Technical Document

{{Short description|Internationally agreed format for drug approvals}}
{{Use dmy dates|date=May 2024}}
[[File:CTD-img004.png|right]]
The '''Common Technical Document''' ('''CTD''') is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.<ref name="junod05">{{cite book |last1=Junod |first1=Valerie |title=Clinical drug trials - Studying the safety and efficacy of new pharmaceuticals |date=2005 |publisher=Bruylant |location=(thesis for Faculté de droit de Genève) Bruxelles |page=107}}</ref>

==Major Synopsis==
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the [[European Medicines Agency]] (EMA, Europe), the [[Food and Drug Administration]] (USA) and the [[Ministry of Health, Labour and Welfare]] (Japan) starting at [[World Health Organization]] International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989.<ref name=junod05/>

The CTD is maintained by the [[International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH).<ref name=junod05/><ref name=fdactd>{{cite news |url=https://www.fda.gov/cber/gdlns/m4ctd.pdf |archive-url=https://web.archive.org/web/20031208063943/http://www.fda.gov/cber/gdlns/m4ctd.pdf |url-status=dead |archive-date=8 December 2003 |title=Guidance for Industry, ICH M4: Organization of the CTD |publisher=U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) |date=August 2001}}</ref>

After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada<ref name="gochc">{{cite news |title=Guidance Document: Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/preparation-drug-submissions-electronic-common-technical-document.html |agency=Health Canada |publisher=Government of Canada |date=2015-05-14}}</ref> and Switzerland.<ref name=junod05/>

Paper CTDs are destined for replacement by their electronic counterparts, the [[eCTD]]s.

==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>

==See also==
* [[Clinical Data Interchange Standards Consortium]]
* [[Clinical trial]]
* [[eCTD]]
* [[Harmonization in clinical trials]]

==References==
{{reflist}}

==External links==
* [http://www.ich.org/ ICH]
* [http://www.ich.org/products/ctd.html Common Technical Document]

[[Category:Clinical research]]
[[Category:Clinical data management]]
[[Category:Pharmaceuticals policy]]
[[Category:Drug safety]]
[[Category:Life sciences industry]]
[[Category:International standards]]