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.
Regulatory agencies are making the regulatory application in the eCTD format mandatory to eliminate the paper format. eCTD helps agencies to track the application, search required information, maintain the life cycle of the application, and easy to review compared to paper applications.
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.
Some eCTD software vendors offer advanced features in their applications, such as optimizing PDF as per regulatory agency requirements and in-built hyperlinking tools.
In-house publishing involves other aspects apart from buying the software. You should consider the below factors before buying the software.
FDAbasics can assist your company in publishing, validating, and submitting regulatory applications in e-CTD format with the most competitive pricing. Contact us for more information.