What is ECTD Dossier?
The Electronic Common Technical Document (eCTD) dossier, based on Common Technical Document (CTD), is a medium through which conveyance of regulatory information is accomplished between the pharmaceutical industry and the agency. It was created and developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
Record Structure of eCTD
The eCTD dossier is a communication arrangement for the conveyance of metadata and files from a sender to a receiver. The prime procedural mechanism are as follows:
- An elevated rank folder composition (required)
- An XML “backbone” file that endows with metadata concerning content archives and lifecycle directives for the receiving arrangement
- An nonobligatory lesser rank folder composition
- Connected stylesheets and document type definitions (DTDs).
Every submission memo comprises of a single “sequence”. A increasing eCTD dossier involves one or more than one sequence. Whereas a sole sequence can be observed and studied with the ICH stylesheet supplied and web browser. Studying an increasing and cumulative eCTD requires dedicated and specialized eCTD viewers.
From the pharmaceutical standpoint the eCTD has five modules. They are as follows:
- Managerial info and prescribing info
- General technological document synopsis
- Quality and worth
- Nonmedical study reports
- Medical study reports
An ultimate, compulsory direction document was published by the U.S. Food & Drug Administration on the 5th of May, 2015. It demanded certain submissions in Electronic Common Technical Document (eCTD) format within 24 hours. The anticipated date for compulsory electronic submissions is 5th of May, 2017 for Abbreviated New Drug Applications (ANDAs), Biologic License Applications (BLAs), Drug Master Files (DMFs), New Drug Applications (NDAs). Records suggest that, till date, more than six hundred thousand eCTD sequences have been submitted to the Food & Drug Administration.