Thai Food and Drug Administration (Thai FDA) released information about the Thai eSubmission project. As per their project plan the Pilot eCTDs will be accepted from October 2014. Formally, eCTD submissions should be accepted from May 2015.
Thai eCTD Module 1 has been developed based on the EU eCTD Module 1 and ICH eCTD specifications for Module 2 to Module 5.
Thai FDA requested applicants to provide feedback to the published eCTD information by end of September 2014.
To find detailed guidances on eCTD Submissions information please follow below links:
1. Thai eCTD Drug E-Submission Project and eCTD Presentation
2. Thai FDA eCTD Specification (Version 0.91)
3. TH Regional Specification and Validation Criteria (Version 0.91)
Thai eCTD Module 1 has been developed based on the EU eCTD Module 1 and ICH eCTD specifications for Module 2 to Module 5.
Thai FDA requested applicants to provide feedback to the published eCTD information by end of September 2014.
To find detailed guidances on eCTD Submissions information please follow below links:
1. Thai eCTD Drug E-Submission Project and eCTD Presentation
2. Thai FDA eCTD Specification (Version 0.91)
3. TH Regional Specification and Validation Criteria (Version 0.91)
5. FAQs (To be published)
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