ASEAN Guidance Documents

ASEAN Registration of Pharmaceuticals for Human Use
(The following were abstracted from the Health Sciences Authority Singapore site)

ASEAN Common Technical Dossier (ACTD)

• Organisation of the Dossier
• Glossary used for the ACTD and ACTR
• Part II: Quality
• Part III: Nonclinical Document
• Part IV: Clinical Document
• ACTD Clinical Check List for Product Classification

ASEAN Common Technical Requirements (ACTR)

• ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration
• Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
• Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
• Annex A3 Guidance on Process Validation Scheme for Terminally Scheme for Terminally Sterilised Products
• Annex B Table of Content of Process Validation Documentation
• Annex D Glossary
• ASEAN Guidelines for Validation of Analytical Procedures
• ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG)
• ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG)
• ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies
• ASEAN Guideline on Process Validation Q&A