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- Common_Technical_Document abstract "The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It 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 (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The Common Technical Document is divided into five modules: Administrative and prescribing information Overview and summary of modules 3 to 5 Quality (pharmaceutical documentation) Preclinical (Pharmacology/Toxicology) Clinical – efficacy (Clinical Trials)Detailed subheadings for each Module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of other Modules will differ, based on national requirements.After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.".
- Common_Technical_Document thumbnail CTD-img004.png?width=300.
- Common_Technical_Document wikiPageExternalLink www.ich.org.
- Common_Technical_Document wikiPageExternalLink ctd.html.
- Common_Technical_Document wikiPageID "1367834".
- Common_Technical_Document wikiPageLength "2106".
- Common_Technical_Document wikiPageOutDegree "12".
- Common_Technical_Document wikiPageRevisionID "660630872".
- Common_Technical_Document wikiPageWikiLink Category:Clinical_data_management.
- Common_Technical_Document wikiPageWikiLink Category:Clinical_research.
- Common_Technical_Document wikiPageWikiLink Clinical_Data_Interchange_Standards_Consortium.
- Common_Technical_Document wikiPageWikiLink Clinical_trial.
- Common_Technical_Document wikiPageWikiLink ECTD.
- Common_Technical_Document wikiPageWikiLink Electronic_common_technical_document.
- Common_Technical_Document wikiPageWikiLink European_Medicines_Agency.
- Common_Technical_Document wikiPageWikiLink Food_and_Drug_Administration.
- Common_Technical_Document wikiPageWikiLink Harmonization_in_clinical_trials.
- Common_Technical_Document wikiPageWikiLink International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use.
- Common_Technical_Document wikiPageWikiLink Ministry_of_Health,_Labour,_and_Welfare.
- Common_Technical_Document wikiPageWikiLink Ministry_of_Health,_Labour_and_Welfare.
- Common_Technical_Document wikiPageWikiLink File:CTD-img004.png.
- Common_Technical_Document wikiPageWikiLinkText "CTD".
- Common_Technical_Document wikiPageWikiLinkText "Common Technical Document".
- Common_Technical_Document hasPhotoCollection Common_Technical_Document.
- Common_Technical_Document wikiPageUsesTemplate Template:Reflist.
- Common_Technical_Document wikiPageUsesTemplate Template:Use_dmy_dates.
- Common_Technical_Document subject Category:Clinical_data_management.
- Common_Technical_Document subject Category:Clinical_research.
- Common_Technical_Document hypernym Set.
- Common_Technical_Document comment "The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.".
- Common_Technical_Document label "Common Technical Document".
- Common_Technical_Document sameAs Common_Technical_Document.
- Common_Technical_Document sameAs Common_Technical_Document.
- Common_Technical_Document sameAs CTD.
- Common_Technical_Document sameAs m.04x540.
- Common_Technical_Document sameAs Skupni_tehnični_dokument.
- Common_Technical_Document sameAs Common_Technical_Document.
- Common_Technical_Document sameAs Q1116233.
- Common_Technical_Document sameAs Q1116233.
- Common_Technical_Document wasDerivedFrom Common_Technical_Document?oldid=660630872.
- Common_Technical_Document depiction CTD-img004.png.
- Common_Technical_Document isPrimaryTopicOf Common_Technical_Document.