10 Small Submissions
No more than 10 Documents per submission
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.
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:
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.