The document describes the five modules of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format for ASEAN countries. Module 1 contains regional administrative information. Module 2 provides an overall summary of Modules 3, 4, and 5, including quality, non-clinical, and clinical overviews. Module 3 includes chemistry, manufacturing, and quality control documents. Module 4 contains non-clinical safety data. Module 5 provides clinical study reports, though generics only need to include bioequivalence studies. The CTD format is required for both new drug and generic applications in ASEAN countries.

1. ICH CTD ASEAN CTD Description Remarks
Module 1:
Regional and
administrativ
e information
Part I
Region specific administrative documents
like application form, legal
documents(GMP, licenses, etc),labelling
etc
Required for generics and
new drug
Module 2:
Overall
summary
Part II
Module summarizes Module 3,4,and 5.It
includes quality overall summary. Non
clinical overview and summary and clinical
overview and summary.Gives the abstract
of documents provided in the whole
application
Required for generics and
new drug.For generics
summary on quality part
only required
Module 3: Quality
Documents related to chemistry,
manufacturing and control (CMC)of both
drug substance and drug product
Required for generics and
new drug
Module 4: Safety
Part III
Non clinical stability reports – Data on
pharmacological, pharmakinetic and
toxicological evaluation
New required for generics
Module 5: Efficacy
Part IV
Clinical study reports‐applicant provides a
critical assessment of the clinical data and
releated reports in the module
Not required for generics
except Bioequivalence
(BE)study
CTD ‐ Common technical document
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