Upcoming new THAI eCTD and Module 1

Upcoming new THAI eCTD and Module 1

Did you know that Food and Drug Agency of
Thailand is releasing new TH Module 1 with TH regional schema V1.0. eCTD
submission? This means that in Thailand it will be mandatory for New Chemical
Entity, New Drug, New Biological, Biological, and optional for Generic and New
Generic in 2016. Furthermore, in 2017 eCTD submission will be mandatory for all
submission.

Asphalion can support you during these
processes. We are experienced in RoW eCTD submission,
having projects in:

  • EU (Centralized procedure,
    DCP, MRP, National procedures…)
  • USA (IND, NDA, ANDA, BLA…)
  • Canada (DMFs, NDS, ANDS)
  • Switzerland
  • Australia
  • GCC

Thai FDA Module 1 eCTD structure has been
designed using structure of Module 1 of European and Canadian as reference. For
the rest of Modules, Thai FDA has based his guidance on International
Conference on Harmonization (ICH), in order to facilitate eCTD compilation
using a user-friendly structure.

Should you need any support in eCTD submission
to Thailand FDA or any procedure involved, please do not hesitate to contact us
at info@asphalion.com

eCTD will become mandatory for ASMF/DMF
Asphalion organized the 2nd Scientific Advice meeting of iHIVARNA project

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