eCTD – The Electronic Common Technical Document

eCTD (electronic Common Technical Document) is a common format for providing regulatory information (such as applications, supplements, and reports) to the relevant Health Authorities. It offers a standardized method for putting the Common Technical Document (CTD) electronically.

An eCTD is made up of distinct PDF documents that are organized hierarchically in accordance with the CTD structure. Additionally, it contains an XML backbone that ties together necessary documents and offers details about the submission.

The introduction of eCTD was done to lighten the workload of the reviewers. Due to the fact that all Regulatory authorities use it as a standard format, it simplifies the process of submission

There is total 5 modules in eCTD

  1. Region-specific information
  2. Summary documents
  3. Information related to quality
  4. Non-clinical study reports
  5. Clinical study reports (CSRs)

eCTD are accepted for the following applications

  1. Investigational New Drug (INDs)
  2. New Drug Applications (NDAs)
  3. Abbreviated New Drug Applications (ANDAs)
  4. Biologics License Applications (BLAs)
  5. All the applications following the submission of the above-stated applications
  6. All the Master Files (MFs) which are part of any above-mentioned applications


  • Uploading sequences automatically with the help of XML backbone
  • Hyperlinks enable reviewers to readily refer to information.
  • There is no need to scan, copy or store paper documents
  • It is simple to identify changes and modifications made to the dossiers
  • Easy product lifecycle tracking
  • Simultaneous accessibility of documents is possible

Taj Pharmaceuticals regulatory department has already incorporate eCTD into our global submission strategies. As an international exports organization we stay up-to-date with the eCTD criteria in order to stay ahead of the competition.