Common Technical Document (CTD)
A CTD is a format used by pharmaceutical companies when submitting their marketing applications to the International Conference on Harmonization (ICH).
More information about Common Technical Document (CTD)
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Relevant documents,technical document,drug regulatory,validation,scope,activities,industry,- Procedures,meetings,methods,active ingredient,application forms,original submission,separate documents,document for illustrations,document button.
Pdf document,document content,document for responses,document headings,document Table,electronic source document,incorrect documents,legal document,multi-page PDF document,non-eCTD formatResponse document,placement of documents.
Requirements for documents,electronic documents,Veterinary Drug,Drug Identification Number,Application for Drug Identification Number,drug product,Biological Drugs,Veterinary Drug Post,Veterinary Drug PSUR,MF Type I – Drug,Cover Letter.pdfSub-subfolder:1.5 Drug Submission ApplicationDocuments,drug notification form,Drug ShortageWhen,pdf file,file names,acceptable file formats,Distribution of master file,file path,Master file enquiries email,regulatory transaction xml file,size of files,content files,digits for master file,process validation,non-eCTD validation rules,technical validation errors,validation criteria,validation report,validation software,sample module,folders in module,correspondence in module,email for Module,letter in module 1.0.1,folder structure requirements,folder structures,incorrect structure,F-3: example folder structure,Equipment-3.2.A.2Adventitious Agents Safety Evaluation-,Agents Safety Evaluation-3.2.A.3Excipients-3.2.R.1.1Executed Production,Equipment-3.2.A.2Adventitious Agents Safety,Equipment-3.2.A.2Adventitious Agents Safety Evaluation-3.2.A.3Excipients-3.2.R.1.1Executed Production,Dossier Identifier,submission of dossiers,Dossier typeDossier,dossier typesFigure,Correspondence-1.0.4Health Canada,Health Canada Building,detailed list,complete list,List of Documents provided,registration process,registration of pharmaceuticals,registration steps,activities in scope,scope of REPTransactions,Transactions within scope,dmf.enquiries-fmm@hc-sc.gc.caClinical trial applications,pdd-pv-dmp@hc-sc.gc.caClinical trial applications,regulatory activity level,Industry – Management,Industry – Preparation,centralised procedure,compliance issues,manual processing issues,(e.g., pre-submission meetings,Presentations for meetings,acceptable method,method of transmissions.