Editing Common Technical Document (section)

==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.