The ectd backbone files specification f or module 1 version 2. Generally high level of granularity in documents structure is more precise lifecycle management of the submission is easier. Module 4 nonclinical study reports module 5 clinical study reports quality overall summary nonclinical overview nonclinical summary clinical summary clinical overview the ctd triangle. This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the ctd. Body of data indicates where the information should be located 3.
Registration of medicines ectd submission in south africa 2. Preparing protocol documents for ectd submissions to the. The ich m4 expert working group ewg has defined the common technical document ctd. Modules 2, 3, 4, and 5 are intended to be common for all regions. The common technical document ctd was designed to provide a common format between europe, usa, and japan for the technical documentation included in an application for the. Reformatted quality documentation submitted in the ctdformat must consist of a new module 3 in ctd format, but need not necessarily contain the quality overall summary together with the signed template for the quality expert.
Guideline on the use of the ctd format in the preparation. Preparing the common technical document for registration. Anda checklist for ctd or ectd format for completeness and acceptability of an application. Can clarity be provided as to where these items should actually be placed in the ctd and an ectd submission. The requirements for the quality documentation module 2. Ctd dossiers common technical document product dossier is an integral part of any registration application for marketing authorization. M 4 qcommon technical document for the registration of. It describes the format and organization of the chemical, pharmaceutical, and biological data relevant to the application. Quality overall summary qos the quality overall summary qos is a summary that follows the scope and the outline of the body of data in module 3. Preparation of drug regulatory activities in the electronic common technical document format 20150611 notice canadian module 1 schema version 2.
Common technical documentpharma dossiersctd format. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities. Modules 2 through 5 contain the ctd and applies to all regions. However, the ctd organization provides a location for literature references in module 5. Utility files to enable technical conformance and viiiewing submission folders, xml and utility files are created aut ti ll if ctd b ild i dtomatically if an ectd builder is used.
In addition, minor editorial corrections and amendments have been introduced in other sections. Module 3 describes the format and organisation of the chemical, pharmaceutical and biological data relevant to the application. Specifically, ectd module 3 contains the pharmaceutical quality documentation. Pdf a comparative study of common technical document in. The common technical document is organized into five modules. The ich m2 ewg has defined, in the current document, the specification for the electronic. A ctd file, a term that refers to any required and relevant document, file or piece of information that is required to be included in the dossier application, must be indexed into one of the five modules that comprise the ctd. For paper submissions, publications and literature references should be located in module. Health canada welcomes regulatory activities using the new module 1 in ctd format at this time.
Ctd dossier preparation pharmaceutical export promotion. This module s principle content and structure is laid down in ich guideline m4q 3. Build module 3 ctd of the dossier to meet regulatory requirements know the legal framework and guidelines for the cmcquality part of the dossier me thl ga rsp o nib f uc authorisation. Ctd module 3 is the section of the common technical document ctd regulatory submissions format that contains all the required quality information and data corresponding to the registration of a pharmaceutical product. Creation of the canadian module 1 backbone ectd 20120907 canadian module. Table of content of module 3 a table of contents for the filed application should be provided 3.
The ctd common technical document is part of the process that has the most direct impact on the daily work of clinical sas professionals. In addition minor editorial corrections and updates have been introduced in the guideline itself. Pharmacovigilance master file riskmanagement system information relating to clinical trials paediatric information dr. Ctd dossier preparation ctd common technical document contains 5 modules module 1 module 2 module 3 module 4 module 5. The clinical summary in module 2 and the clinical study report in module. In addition, this training course addresses quality by design aspects and issues. Once a product has been moved to the new module 1 format, it may not be reverted to the old module. The course is for new developments, but is also very much attractive for generics. The common technical document ctd is a set of specifications for an application dossier for the registration of medicines and designed to be used across europe, japan and the united.
Dmf drug master file dmf is a submission to the food and drug administration fda that may be used to provide confidential detailed. Reformatted quality documentation submitted in the ctd format must consist of a new module 3 in ctd format, but need not necessarily contain the quality overall summary together with the signed template for the quality expert. This module is an eu ctd document adopted in australia. Fda ectd table of contents headings and hierarchy pdf 73kb updated 772005 ectd backbone files specification for module 1 pdf 102kb updated 122006 ectd backbone file specification for modules 2 through 5 3. Nonclinical reports pharmacology toxicology module 5. Electronic transfer of information to the fda based on common technical document ctd format. The qos should not include information, data or justification that was not already included in module 3 or in other parts of the ctd. The common technical document ctd is a set of specifications for a dossier for the registration of medicines. If the original part ii contained data on bioequivalence. For further guidance on the content of module 3 on quality within dossiers for thmps, a mockup has been included as appendix 2 to help the applicant with their submissions. This document provides specifications for creating the electronic common technical document ectd backbone file for module. Section 8 ectd backbone files specification for module 1. The structure and organisation of an ectd submission is defined by the following standards. Organisation of the common technical document the common technical document is organized into five modules.
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