PART 4: Clinical Documents

A : Table of Content

(Ref. SECTION E: CLINICAL STUDY REPORTS, PART IV: CLINICAL DOCUMENT of the ASEAN Common Technical Dossier [ACTD])

To provide the full clinical study reports. The ICH E3 provides guidance on the organisation of clinical study reports, other clinical data, and references within the ASEAN Common Technical Dossier (ACTD) for registration of a pharmaceutical product for human use.

Please refer:

The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals For Human Use – Part IV : Clinical Document

 

B: Clinical Overview
C: Clinical Summary
D: Tabular Listing of all Clinical Studies
E: Clinical Study Reports
F1: List of Key Literature References
F2: Published Clinical Papers
F3: Periodic Safety Updates Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER).
F4: Risk Management Plan(s)

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