May 20, 2024

ASEAN Common Technical Document (ACTD), Parts of ACTD

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). 

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

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