ASEAN Common Technical Document (ACTD), Parts of ACTD, Countries of ASEAN
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) application which was submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.
This CTD format is a guideline that will describe the resources needed to compile applications for registration and significantly reduce the time. This guideline merely demonstrates an appropriate write-up format for acquired data.
The display of information should be straightforward and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly align to the application contents. The ACTD’S advantage is that one dossier can be prepared for all ASEAN countries, reducing efforts and facilitating the regulatory review process.
Countries of ASEAN
- 1. Laos
- 2. Burma (Myanmar)
- 3. Thailand
- 4. Singapore
- 5. Vietnam
- 6. Cambodia
- 7. Malaysia
- 8. Brunei
- 9. Indonesia
- 10. Philippines
Parts of ACTD
ACTD is organized into 4 parts:
Part I: Common administrative data and product information.
Section A- Introduction.
Section B- ACTD Table of contents.
Section C-Administrative documents (Application form, letter of authorization, Certification documents, labelling, Product data sheet, Prescription information, etc.).
Part II: Quality (for all categories of products).
Section A- Table of contents
Section B- Quality overall summary
Section C- Body of data
Part III: Non-clinical data (for innovator drug, new chemical entity and biotechnological products).
Part IV: Clinical data (for innovator drugs, new chemical entities and biotechnological products).
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