Guideline for drug registration from Cambodia

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Guideline for drug registration from Cambodia
Guideline for drug registration from Cambodia
Guideline for drug registration from Cambodia
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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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