In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...

All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...

How to cut time and cost by re-using already submitted documents. Increasing drug-development costs, patent expirations, and fewer blockbuster drugs in the pipeline are forcing life-science companies ...

The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should ...

Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.

Joshua Boutwell, President and CEO of Aquila Solutions said, “We are pleased that our expertise in eCTD authoring is now available to everyone. We know our eCTD Templates will help sponsors save time ...

Factorytalk, a leading digital solutions provider and consultancy for the life sciences industry, is thrilled to announce the successful upgrade and enhancement of Thailand’s electronic Common ...