Electronic Common Technical Document (eCTD)
The Electronic Common Technical Document or eCTD, is the best practice or digitized standard format for related parties to submit applications, amendments, supplements, and reports to various regulatory agencies in multiple International Council of Harmonisation (ICH) participating countries.
The Common Technical Document (CTD) template was developed by the ICH and has become adopted internationally as the accepted method for the pharmaceutical industry to transfer regulatory information. This includes submission to the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
With digital transformation occurring over the past several decades, paper submissions have been found to be cumbersome and too unproductive. As a result, the CTD was turned into an electronic version — eliminating the need for large paper submissions.
eCTD Publishing and Submission
As of May 5, 2018, all marketing and commercial IND applications, all subsequent submissions to these applications, and most master files, are required by the US FDA to be submitted using the eCTD format. Our regulatory publishing team will support the electronic publishing and submission of your regulatory documents to US FDA through the Electronic Submission Gateway (ESG). Our team is highly experienced in navigating the complex publishing requirements using industry-leading publishing systems and tools.
The Components of an eCTD Submission
In order for an eCTD submission to be accepted for review, a specific set of guidelines must be met by the submitting party. There are five key modules that go into the creation of a successful eCTD submission.
eCTD submissions require a high degree of attention to detail and a comprehensive strategy for the collection and formation of all the necessary documents and data sets required. eCTD submission requirements apply to all the following types:
- Commercial Investigational New Drug (IND)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- Master Files (MFs)
eCTD Guidance & Publication Aid
The implementation of eCTD into standardized practice has yielded a long list of benefits for both pharmaceutical players and regulatory agencies. The eCTD has helped streamline processes, reduce costs and time loss, as well as eliminate paper waste. However, due to the high degree of specialization and regulatory detail that is required of a proper eCTD, many submitting parties fail to pass on all mandatory guidance requirements.
The inability to meet eCTD submission requirements can lead to delays in therapy and drug studies, approval, marketing, and more. It is in the best interest of all parties involved, from sponsors to the FDA to designed end-patient users, that a submitted eCTD is done thoroughly and correctly the first time.
In order to ensure this outcome, many pharmaceutical companies and sponsors turn to third-party experts like BioPharma Global to help in the compiling, creation, submission, and publication of an eCTD.
eCTD Guidance & Services
While the FDA provides eCTD submission guidance, digging through these PDF documents and navigating the process on your own can quickly become overwhelming, inefficient, and prone to mistakes — even for the most experienced industry professionals.
BioPharma Global has worked with countless pharmaceutical companies and sponsors to aid in their eCTD submission process. We are able to offer a variety of benefits for those parties needing to submit an eCTD.
One of the biggest advantages is that we have the capability for publishing submissions and submitting via electronic submission gateway (ESG). In doing so, we:
- Leverage the same publishing and validation software as the FDA
- Can help in formatting and optimizing all required documents prior to submission
- Will walk through agency preferences and conventions with the client to ensure optimal formatting
- Ensure all submissions pass validation using the most up-to-date FDA standards
- All submissions MUST pass validation using software that is up-to-date with FDA’s conformance standards.
- Validation errors come in three grades, with only mild and moderate errors given minor exceptions for submission to ESG
In conjunction with this, BioPharma Global has a secure account established with FDA’s ESG and will also handle submitting the final published product to the current agency review division. We are also able to communicate directly with the project manager on behalf of the client as needed — this is required for non-U.S. clients (U.S. Agent).
If your organization is needing to navigate the eCTD submission process or has struggled to do so in the past, get in contact with us today. BioPharma Global has a proven track record of helping businesses achieve regulatory compliance and meet strict guideline standards.