The electronic common technical document (eCTD) is an interface for the pharmaceutical industry to transfer regulatory information based on the Common Technical Document (CTD) format, which is an agreed common format for applications that will be acceptable in all three ICH-Regions (US, EU & Japan) and other countries. The US is already accepting the electronic format submissions and for submissions that do not use eCTD will not be filed or received based on section 745(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) & Conformance Guide release in 2015 making the eCTD format mandatory for NDA, ANDA & BLA starting May 5, 2017 and for IND starting in May 2018. eCTD submissions are already mandatory in the EU and are accepted in Australia and Japan.
A common format for the technical documentation significantly reduces the time and resources needed to compile applications for registration of human pharmaceuticals, eases the preparation of electronic submissions, facilitates regulatory reviewers and communication with the application by a standard document of common elements and simplifies exchange of regulatory information between regulatory authorities.
These benefits are well recognized and underpin the decision to move to esubmissions. As part of the process, the Center for Drug Evaluation & Research (CDER) has initiated an acknowledgement to FDA Electronic Submissions Gateway (ESG) users with successful validation of an NDA, ANDA, BLA, IND or DMF submission; this acknowledgement will need to be part of your structured eCTD submission process.
Points that you will want to consider for esubmission readiness include:
- Is there a set process to convert legacy reports and non-eCTD/paper dossiers to eCTD dossiers?
- Is planning adequate to ensure that current submissions are ready for lifecycle management?
- Are the right tools used for authoring and publishing eCTD submissions?
- Can medium severity errors during validation be handled, to avoid “refuse to file” during the 60-day review period?
What are the next steps?
- Become familiar with the new standards
- Follow the technical specifications
- Plan to convert existing documents and use effective planners during the conversion process
- Acquire necessary permissions and accounts for ESG submissions
- Validate a sample submission and standardized data sets
- Reach out to service providers or appoint an SME to help plan and execute structured eCTD submissions
Bioclinica can help your organization at all steps in this process. Please contact me at firstname.lastname@example.org for additional information.