What is it about Electronic common technical document?
Posted by Aaryan Smith on May 11th, 2021
The electronic common technical document (eCTD) is an interface and an international specification for all the pharmaceutical industries and IT industries for the transfer of regulatory information for governing all of them. The specification here is based on the Common Technical Document (CTD) format, and the International Council developed it for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). eCTD regulation submission's structure is vastly defined by the primary standard created by the ICH, the Electronic Common Technical Document Specification. However, additional specifications can be applied in national and continental contexts.
The eCTD regulation generally has five modules from a pharmaceutical point of view. They are
There are two categories of modules:
eCTD submission's structure is primarily distinguished by the primary standard created by the ICH, i.e., the Electronic Common Technical Document Specification. However, many additional rules can also be applied in the national and continental contexts in different countries. In a context, the Food and Drug Administration (FDA) layer also gives additional specifications onto the things required for eCTD submissions, which generally includes PDF, transmission, file format, and supportive file specifications.
e-CTD regulation components for IT point of view
The eCTD is a message of specifications commonly known as the transfer of files and metadata from a submitter to the receiver of all the information.
The primary technical components required here are:
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About the AuthorAaryan Smith
Joined: January 29th, 2018
Articles Posted: 17
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