10 Small Submissions
No more than 10 Documents per submission
ASEAN eCTD
Country: Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
Health Authority: National Pharmaceutical Regulatory Agency (NPRA) – Malaysia, Health Sciences Authority (HSA) – Singapore, Thailand Food and Drug Administration (Thai FDA)
eCTD, Accepted Since: Thailand accepts in eCTD format and rest of the countries accepts NeeS submissions in Common Technical Dossier format
eCTD Version: Module 1 v1.0 for Thailand, ICH 3.2.2
Types of Applications
Initial, Variation-1, Variation-2, Report-1, Report-2, etc.
Process to be followed in making an ASEAN eCTD submission
- Learn about the Part I, Part II, Part III, and Part IV for ASEAN Common Technical Dossier requirements
- Review the ASEAN Common Technical Dossier submission guidance
- Submit administrative forms and compliant PDFs
- Submit the eCTD submission via electronic media
Mandatory Deadlines
- Currently Thailand accepts eCTD format and rest of the countries accepts NeeS submissions in CTD format
How can Freyr help?
- Freyr supports to build eCTD format for Thailand and CTD submissions for other ASEAN countries
Other Countries
USA, EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, NMPA
