1 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER PREAMBLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD)...
The ASEAN Common Technical Dossier (ACTD) was created with the aim to serve as a harmonized guideline for pharmaceutical product registrations in the ASEAN countries. The use of a common format is intended to simplify the registration process and reduce the time and resources needed to put togeth...
In Malaysia, the Philippines, and Thailand, the registration requirement is satisfied by the submission of the ASEAN common technical dossier (ACTD). In other member states, they necessitate the submission based on the requirements particular to their region. This study ...