Guideline for drug registration from Cambodia

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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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Guideline For Drug Registration- ACTD format- from Cambodia FDA

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Ngày viết:
Vietnam Regulatory Affairs Society. Join us, VNRAS, feel free to contact. We'll provide you all information and regulatory affairs update related to products covered by the Ministry of Health of Vietnam (drug, vaccine, biological, pharmaceutical raw material, excipient, capsule, traditional medicine, herbal medicine, medical equipment, invitro diagnostic medical devices, cosmetic, food supplements, chemical and preparation for medical and household use).
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