The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptation of Pilot eCTD from October 2014 and authority has scheduled to receive the eCTD submission from May 2015.

Thai eCTD Module 1 has been developed based on the EU eCTD Module 1 and ICH eCTD specifications v3.2.2 for Module 2 to Module 5.

Thai FDA released the TH eCTD (Thai eCTD) Module 1 Specifications draft version 0.91 and validation criteria, draft version 0.91.

Useful Links:

Thai FDA eCTD Project and Specification Presentations

http://drug.fda.moph.go.th/eng/e_submiss.asp

The Thai eCTD specification (Version 0.91)
http://drug.fda.moph.go.th/eng/files/TH%20Module%201%20and%20Regional%20Specification.pdf

Regional specification and Validation Criteria (0.91)
http://drug.fda.moph.go.th/eng/files/TH%20Regional%20Specification%20and%20Validation%20Criteria.pdf

Schema files
http://drug.fda.moph.go.th/eng/files/th-regional-schema-0.91.zip