10 Small Submissions
No more than 10 Documents per submission
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 CTD format
eCTD Version: Module 1 v1.0 for Thailand, ICH 3.2.2
Initial, Variation-1, Variation-2, Report-1, Report-2, etc.