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.
eCTD offers systematic approach for regulatory filings in the digital format. Regulatory agencies can easily track life cycle of the regulatory submissions. Application holder can easily replace the documents and submit the updated, append or delete the document .
ICH (International Conference for Harmonization) has published harmonized eCTD specification for module 2 to module 5 . Module 1 specification 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 task and requires XML editing knowledge. Before publishing eCTD, you may have to insert 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 application 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 to publish , validate and submit regulatory applications in e-CTD format with most competitive pricing, contact us for more information