eCTD Triangle and Modules

A closer look into the eCTD triangle and its modules

CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.

What is the eCTD?

It is used for the preparation of applications for new drugs that need to be submitted to the regional regulatory authorities in all participating countries across Europe, Japan and the United States.

 

eCTD Triangle Modules Infographic

The paper CTD is destined to be replaced by the electronic version, called eCTD, and makes regulatory review processes easier.