What are the benefits of eCTD 4.0?
Updated timeline for the use of eAFs for variations in human drugs
Where is DADI? - The new EMA eAF: Definition and Impact
When can companies expect to use eCTD 4.0?
What is eCTD 4.0?
What are the regional differences of eCTD?
What are the five Modules of eCTD? - Introduction to the CTD Triangle
What is eCTD? - The story of the electronic Common Technical Document
Regulatory Authorities worldwide - an overview list
The EMA published the FHIR Conceptual Data Model (CDM)
US FDA Adverse Event Reporting System (FAERS) Electronic Submissions
EMA Publishes New Timeline For DADI Project