ASEAN COMMON TECHNICAL DOCUMENTS (ACTD)
                                                        and
              ASEAN COMMON TECHNICAL REQUIREMENTS (ACTR)
                                                        Posted: 05 December 2007

BFAD ISSUANCE

BC 2007-011: Adoption of the Association of Southeast Asian Nations Common Technical Documents (ACTD) and Common Technical Requirements (ACTR) on Pharmaceutical Product Registration for Human Use

ACTD

1.  ASEAN Glossary

2.  Organization of Dossier
     2.1.  Part   I: Table of Contents, Administrative Data, and Product Information

     2.2.  Part  II: Quality Document
     2.3.  Part III: Nonclinical Document

     2.4.  Part IV: Clinical Document

ACTR

1.  ASEAN Guidelines on Stability Study of Drug Product

2.  ASEAN Guidelines on Validation of Analytical Procedures

3.  ASEAN Guidelines on Submission of Manufacturing Process Validation Data for

     Drug Registration

4.  ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies

5.  Guidelines on Nonclinical Documents

6.  Guidelines on Clinical Documents