Electronic Common Technical Document (eCTD) - White Paper

The Electronic Common Technical Document or eCTD is 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 was 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. As of May 5, 2018, all marketing and commercial IND applications, all subsequent submissions to these applications, and most drug master files are required by the US FDA to be submitted using the eCTD format. Biopharma Global 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.

Download our white paper to learn more about the eCTD process.

eCTD White Paper

Who is BioPharma Global?

BioPharma Globalis a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A/B/C meeting assistance, IND filings, or electronic submissions, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.