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THE ASEAN COMMON TECHNICAL DOSSIER …

THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE registration OF PHARMACEUTICALS FOR human USE PART II: QUALITY 1 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE registration OF PHARMACEUTICALS FOR human USE PART II: QUALITY TABLE OF CONTENTS Scope of the Guideline .. 2 Section A: Table of Contents .. 2 Section B: Quality Overall Summary .. 2 Section C: Body of Data 9 1. Drug Substance .. 9 2. Drug Product .. 14 Section D: Key Literature References .. 20 2 Scope of The Guideline This document is intended to provide guidance on the format of a registration application for drug products regarding ASEAN CTR.

the asean common technical dossier (actd) for the registration of pharmaceuticals for human use part ii: quality

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