Release Announcement

Full support for Thai eCTD submissions

The Thai Food and Drug Agency started accepting eCTD submission in May 2015 and announced to make eCTD submissions mandatory from 2017.

Applicants can submit their applications with version 1.0 of the Thailand eCTD Module 1 and Regional Specification from 1 January 2016.

The main functionality of the TH eCTD Compiler, part of eCTD Office, is the creation of valid TH FDA electronic dossier submissions along with the lifecycle management.

TH eCTD Compiler in Action!

eCTD Office is fully compliant with TH eCTD specification Module 1 regional information, version 1.0 and Thai FDA eCTD Validation Criteria, version 1.0/01.

Contact us for more info…
TH eCTD Compiler March, 2016