ASEAN Common Technical Dossier
This research report provides a comprehensive overview of the ASEAN Common Technical Dossier (ACTD) for the registration of pharmaceuticals for human use. The ACTD aims to harmonize the pharmaceutical registration process among ASEAN member states, facilitating the understanding and evaluation of technical data during the registration process.
(Generated with the help of GPT-4)
| Quick Facts | |
|---|---|
| Report location: | source |
| Language: | English |
| Publisher: |
ASEAN Secretariat |
| Page count: | 198 |
Methods
The research method used in the report involves the establishment of a guideline for the preparation of the Common Technical Dossier (CTD) for pharmaceutical registration within the ASEAN region. This guideline, known as the ASEAN Common Technical Dossier (ACTD), provides a standardized format for presenting technical information to regulatory authorities, with the goal of simplifying the registration process and facilitating the review of applications.
(Generated with the help of GPT-4)
Key Insights
The ASEAN Common Technical Dossier (ACTD) is a guideline for the preparation of a well-structured Common Technical Dossier (CTD) for pharmaceutical registration within ASEAN member states. It outlines the agreed-upon format for applications submitted to regulatory authorities, aiming to streamline the registration process and facilitate the review of applications. The ACTD covers the organization of the dossier, quality documents, nonclinical and clinical documents, and provides a standardized approach to presenting technical information for pharmaceutical registration.
(Generated with the help of GPT-4)
Additional Viewpoints
Categories: English publication language | asean | guideline | pharmaceuticals | registration | standard | technical regulations