Aquila Solutions

 eCTD software commonly abbreviated as the electronic common technical document is the most ideal option for electronic submission to the CDER- Centre for Drug Evaluation & Research and also to the CBER-Centre for Biologics Evaluation & Research.  In this blog, we are going to discuss the process via which this electronic submission can be done conveniently.  eCTD 4.0 Implementation Status Both CDER & CBER are very much interested in this eCTD Submission Software and are coordinating with our industry technical pilot support to perform this eCTD v4.0 submission testing in 2022. Both are planning to accept the new applications in the eCTD v.40 formats in 2023.  What’s New in eCTD v.4? Single Submission Unit Message The eCTD v.4 messages contain all the basic information that is necessary to submit a complete sequence to the FDA. In this submissionunit.xml is used widely to organize both the ICH and regional sequence content, which includes the study data that was previousl

 Now, most of the regulatory bodies around the world are preparing for the transition to version 4.0 of the eCTD Publishing Service. Japan has already started using this eCTD 4.0, while Canada and some other United States will accept this eCTD 4.0 in the next year. Some other countries are also interested in installing this eCTD 4.0 by 2024. Switzerland & European unions are also in this race; by the end of this decade, new standards will be mandatory for most global regions. Certain pharmaceutical manufacturers are also trying to transition to eCTD 4.0, and now it’s a good time to review the workflows associated with the eCTD Publishing Service . Now the current requirements for regulatory submissions using the eCTD Publishing Tools are more stringent.  Now, most organizations are focusing on addressing technologies like digital therapeutics and many more. Emerging technologies like wearable medical devices and other digital therapeutics are also promoted. Data silos also compoun