It would be a vast understatement to say that new drug and biologics applications are “complicated.” New submissions can include hundreds or thousands of documents. So, it’s not hard to figure out why regulatory reviewers wanted to standardize the submission format, cross link documents within submissions and make it fully digital.
Regulators from the US FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) now shun binders and require that new drug and biologics applications be submitted in Electronic Common Technical Document (eCTD) format. eCTD is simply the electronic version of a CTD submission. Other markets that have implemented eCTD include include Australia, Brazil, Canada, China, Europe, GCC countries, Japan, Jordan, Singapore, South Africa, South Korea, Switzerland, Taiwan, and Turkey.