eCTD Requirements and cost effective solutions

Electronic Common Technical Document -eCTD

eCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4, and 5 and customized administrative module 1 according to country-specific requirements.

Contents of e-CTD

The typical folder structure of eCTD Initial application

Why eCTD format?

Regulatory agencies are making the regulatory application in the eCTD format mandatory to eliminate the paper format. eCTD helps agencies track the application, search for required information, maintain the application's life cycle, and make it easier to review compared to paper applications.

Advantages of eCTD

How to prepare eCTD?.

ICH (International Conference for Harmonization) has published harmonized eCTD specifications for module 2 to module 5. Module 1 specifications are established by country-specific agencies. There are several softwares available in the market for e CTD publishing. You can publish eCTD without software. However, it is too complex a task and requires XML editing knowledge. Before publishing eCTD, you may have to insert a bookmark, table of contents, hyperlinks, and prepare the PDF documents as per the regulatory agency standards. Links for agency-specific documents are provided below.