WASHINGTON Beginning in January 2008, all electronic submissions to the Center for Drug Evaluation and Research must use the electronic common technical document format, according to bio-itworld.com
This applies to new drug applications, biologics license applications and investigational new drug applications.
Through its structure, the eCTD enables the creation, review, lifecycle management and archiving of electronic submissions and meets a list of criteria that make submissions technically valid.
Virginia Ventura, regulatory information specialist in CDER’s Office of Business Process Support, sees the eCTD as a major step forward. “The eCTD is paperless and establishes a single application format for all applications, is consistent with International Conference on Harmonisation guidelines, and avoids duplicative internal processes,” she explains.