REQUIREMENT DOCUMENT FOR REGISTRATION OF GENERIC PRODUCT
ACTD GUIDELINE FDA CAMBODIA
PART I – ADMINISTRATIVE DATA & PRODUCT INFORMATION
SECTION A: INTRODUCTION
Introduction:
This section contains the Administrative Data and Product Information which is the part I of the ASEAN Common Technical Document (ACTD) for application to the Drug Regulatory Authority
SECTION B: OVERALL TABLE OF CONTENTS
Table of contents
1- Application Form for Marketing Authorization
2- Letter of Authorization
3- Certification
4- Labeling
5- Product Information
SECTION C – ADMINISTRATIVE DATA & PRODUCT INFORMATION
PART II – QUALITY DOCUMENT
SECTION A: Table of Contents
Table of contents
Description
A-Drug Substance
S1 : General Information
S1.1 : Nomenclature
S1.2 : Structural formula
S1.3 : General Properties
S2 : Manufacture
S2.1 : Manufacturer ( s )
S2.2 : Description of Manufacturing Process and Process Controls
S2.3 : Control of Materials
S2.4 : Controls of critical Steps and Intermediates
S2.5 : Process Validation and/or Evaluation
S2.6 : Manufacturing Process Development
S3 : Characterization
S3.1 : Elucidation of Structure and Characteristic
S3.2 : Impurities
S4 : Control of Drug Substance
S4.1 : Specification
S4.2 : Analytical Procedures
S4.3 : Validation of analytical procedures
S4.4 : Batch analyses
S4.5 : Justification of Specification :
S5 : Reference Standards or Materials
S6 : Container Closure System
S7 : Stability
Stability Summary & Conclusion
Post-approval Stability Protocol & Stability Commiment
Stability Summary Data
B-Drug Product
P1 : Description and Composition
P2 : Pharmaceutical Development
P2.1 : Information on Development Studies
P2.2 : Component of Drug Product
P2.2.1 : Active ingredient
P2.2.2 : Excipients
P2.3 : Finished product
P2.3.1 : Formulation Development
P2.3.2 : Overages
P2.3.3 : Physicochemical and Biological Properties
P2.4 : Manufacturing Process Development
P2.5 : Container Closure System
P2.6 : Microbial Attributes
P2.7 : Compatibility
P3 : Manufacture
P3.1 : Batch formula
P3.2 : Manufacturing Process and Process control
P3.3 : Control of Critical Steps and Intermediates
P3.4 : Process Validation and/or Evaluation
P4 : Control of Excipients
P4.1 : Specification
P4.2 : Analytical Procedures
P4.3 : Excipients of Human and Animal Origin
P4.4 : Novel excipients
P5 : Control of Drug ( Finished ) Product
P5.1 : Specification
P5.2 : Analytical Procedures
P5.3 : Control of Analytical Procedure
P5.4 : Batch Analyses
P5.5 : Characterization of Impurities
5.6 : Justification of Specification
P6 : Reference Standards and Materials
P7 : Container Closure System
P8 : Product Stability
Stability Summary and Conclusison
Post – approval stability and stability commitment Stability data
P9 : Product Interchangeability
SECTION B: QUALITY OVERALL SUMMARY
SECTION C: BODY DATA
A-Drug Substance
B-Drug Product
Guideline for drug registration from Cambodia
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Guideline For Drug Registration- ACTD format- from Cambodia FDA
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