eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically. An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure. It also has an XML backbone which cross-links required documents and provides information regarding the submission. The purpose of introducing eCTD was to reduce the burden on the reviewers of the HAs. It also simplifies the process of submission as all the Regulatory authorities use it as a standard format.
There are total five modules in eCTD
- Region-specific information
- Summary documents
- Information related to quality
- Non-clinical study reports
- Clinical study reports (CSRs)
eCTD submissions are accepted for the following applications
- Investigational New Drug (INDs)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- All the applications following the submission of the above-stated applications
- All the Master Files (MFs) which are part of any above-mentioned applications
Major countries, such as the US, Europe, Australia, Canada, South Africa, Thailand, and Japan, are using eCTD as a standard format for submissions of documents because of numerous advantages that it offers over the traditional submission method. Some of which are:
- Allows agencies to upload sequences automatically with the help of XML backbone
- Reviewers can refer information easily with the help of hyperlinks
- No need to scan, copy or store paper documents
- Changes and updates made to the dossiers can be easily identified
- Easy product lifecycle tracking
- Simultaneous accessibility of documents is possible
eCTD is already included in global submission strategies of companies, worldwide. To stay ahead in the competition, companies are required to stay up-to-date with the eCTD requirements. Are your submissions eCTD compliant? Reach to Freyr at sales@freyrsolutions.com to know more about eCTD submissions.