ASEAN Common Technical Dossier (ACTD) is a guideline upon common format for preparation of a well-organized Common Technical Dossier (CTD) applications that will be filed to the ASEAN regulatory agencies for the registration of drugs intended for human consumption.

This guideline outlines a CTD format that, in the future, will make it simpler to prepare electronic document submissions and will greatly cut down on the time and resources needed to put together in registration of applications.

The presentation of data should be transparent and straightforward throughout the ACTD in order to make it easier to evaluate the fundamental information and to aid in a reviewer’s quick orientation to the application’s contents.

Countries of ASEAN

1. Laos

2. Burma (Myanmar)

3. Thailand

4. Singapore

5. Vietnam

6. Cambodia

7. Malaysia

8. Brunei

9. Indonesia

10. Philippines

ACTD Parts

ACTD is organized into four parts:

Part I: Common Administrative data and Product Information.

Section A – Introduction.

Section B – ACTD Table of contents.

Section C – Administrative documents and Product Information

Part II: Quality – All categories of products

Section A- Table of contents

Section B- Quality overall summary

Section C- Body of data

Part III: Non-clinical data – Innovator drug, new chemical entity and biotechnological products

Part IV: Clinical data – Innovator drugs, new chemical entities and biotechnological products