Drug Registration Guidance Document (DRGD),Third Edition, First Revision July 2021

INTRODUCTION
  • This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products.
 
  • This DRGD shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia, which include but are not limited to the following:
 
  1. Sale of Drugs Act 1952;
  2. Control of Drugs and Cosmetics Regulations 1984;
  3. Dangerous Drugs Act 1952;
  4. Poisons Act 1952;
  5. Medicines (Advertisement & Sale) Act 1956;
  6. Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
  7. International Trade in Endangered Species Act 2008 (Act 686).
 
  • The written laws shall take precedence over this guidance document in any event of discrepancy.

This guidance document is issued by the Director of Pharmaceutical Services under Regulation 29Control of Drugs and Cosmetics Regulations 1984.

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DRGD Appendices

Document Name Updated
Drug Registration Guidance Document (DRGD), 3rd Edition, First Revision July 2021 (Main body) July-2021
Appendix 1 : Food Drug Interphase (FDI) Products July-2021
Appendix 2 : Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products July-2021
Appendix 3 : Guideline on Registration of New Drug Products July-2021
Appendix 4 : Guideline on Registration of Biologics July-2021
Appendix 5 : Guideline on Registration of Generics July-2021
Appendix 6 : Guideline on Registration of Health Supplements July-2021
Appendix 7 : Guideline on Registration of Natural Products July-2021
Appendix 7A : Homeopathic Products  July-2021
Appendix 7B : Guideline on Natural Products with Therapeutic Claim July-2021
Appendix 8 : Supplementary Documentation (Particulars of Product Owner and Manufacturer) July-2021
Appendix 9 : Fees July-2021
Appendix 10 : Data Exclusivity  July-2021
Appendix 11 : Regulatory Control of Active Pharmaceutical Ingredients (APIs) July-2021
Appendix 12 : Priority Review July-2021
Appendix 13 : Designation and Registration of Orphan Drugs July-2021
Appendix 14 : Evaluation Routes  July-2021
Appendix 15 : Requirements for Full Evaluation and Abridged Evaluation July-2021
Appendix 16 : Bioequivalence (BE) Requirements July-2021
Appendix 17 : Product Names Not Permitted to Be Registered July-2021
Appendix 18 : List of Permitted, Prohibited and Restricted Substances July-2021
Appendix 19 : General Labelling Requirements July-2021 
Appendix 19A : Prohibited Visual/ Graphics/Statements on Label July-2021
Appendix 20 : Specific Labelling Requirements July-2021 
Appendix 21 : Special Conditions for Registration of a Particular Product or Group of Products July-2021 
Appendix 22 : Educational Materials July-2021 
Appendix 23 : Patient Dispensing Pack for Pharmaceutical Products  July-2021 
Appendix 24 : Appeal July-2021 
Appendix 25 : Guideline for the Submission of Protocol of Analysis (POA) July-2021 
Appendix 26 : Guideline for the Submission of Analytical Method Validation (AMV) Documents July-2021 
Appendix 27 : Inspection July-2021 
Appendix 28 : Licensing July-2021 
Appendix 29 : Certificate July-2021 
Appendix 30 : Conditions and Supporting Documents Required for an Application of Variation July-2021 
Appendix 31 : Change of Manufacturing Sites (COS) July-2021 
Appendix 32 : Change of Product Registration Holder July-2021 
Appendix 33 : Explanatory Notes for Repackers July-2021 
Appendix 34 : Guideline on Safety Data Requirements for Complementary Medicine Products July-2021 

DRGD Table of Contents

Section A : General Overview
1. Introduction
2. Product Definition
3. Product Classification (Appendix 1 to 7)
4. Exemptions for Products Not Registered With Authority
5. Application Procedures
    5.1 Who Shall Apply for Product Registration
    5.2 Responsibilities of the Applicant
    5.3 How To Apply
    5.4 Fees (Appendix 9)
Section B : Product Registration Process
6. Preparation of Submission of Application
    6.1 Category of Product
    6.2 Data Exclusivity (Appendix 10)
    6.3 Type of Application
          6.3.1 Application for Priority Review (Appendix 12)

          6.3.2 Registration of Combination Pack (Combo Pack)
          6.3.3 Registration of For Export Only (FEO) Product
          6.3.4 Designation and Registration of Orphan Medicines (Appendix 13)
          6.3.5 Variants
          6.3.6 Multiple Applications
          6.3.7 Second or Third Source
    6.4 Evaluation routes (Appendix 14)

7. Regulatory Requirements

    7.1 Requirements for Full Evaluation and Abridged Evaluation    (Appendix 15)         
    7.2 Bioequivalence (BE) Requirements (Appendix 16)         
    7.3 Product Name  (Appendix 17)
    7.4 Ingredients (Appendix 18)        
    7.5 Indications         
    7.6 Labelling Requirements (Appendix 19, 19A, 20)
    7.7 Special Conditions for Registration of a Particular Product or Group of Products  (Appendix 21)
    7.8 Educational Materials (Appendix 22)    
    7.9 Packaging           
          7.9.1      Shrink wrapping              
          7.9.2      Starter Pack/ Patient Initiation Pack/ Dose Adjustment Pack         
          7.9.3      Patient Dispensing Pack (Appendix 23)

    7.10 Proposed Package Insert             
    7.11 Consumer Medication Information Leaflet (RiMUP)         
    7.12 Product Authentication
    7.13 Language             
    7.14 Halal Logo            
    7.15 Directives           

8. SUBMISSION OF APPLICATION

9. SCREENING OF APPLICATION
    9.1 Satisfactory       
    9.2 Non-Satisfactory             

10. EVALUATION OF APPLICATION
      10.1 Initiation of Review        
      10.2 Correspondence             
      10.3 Evaluation Timeline for Product Registration       

11. REGULATORY OUTCOME
      11.1 Decisions of The Authority           
      11.2 Product Registration Number     
      11.3 Certificate of Registration            
      11.4 Appeal Towards Decision of The Authority (Appendix 24)           

 

 

Section C : Quality Control
12. GUIDELINE FOR THE SUBMISSION OF PROTOCOL OF ANALYSIS (POA) (Appendix 25)

13. GUIDELINE FOR THE SUBMISSION OF ANALYTICAL METHOD VALIDATION (AMV) DOCUMENTS (Appendix 26)

14. GUIDELINE FOR THE SUBMISSION OF PRODUCT SAMPLES FOR LABORATORY TESTING
      14.1        Natural Products             
      14.2        Pharmaceutical Products (Upon NPRA request)
Section D : Inspection, Licensing, Certificates
15. INSPECTION (Appendix 27)

16. LICENSING (Appendix 28)

17. CERTIFICATE (Appendix 29)
Section E : Post Registration Process
18. MAINTENANCE OF REGISTRATION (RE-REGISTRATION)

19. WITHDRAWAL OF PRODUCT REGISTRATION

20. AMENDMENTS TO PARTICULARS OF A REGISTERED PRODUCT
      20.1        Variation             
                     20.1.1    Variation Application for Pharmaceutical Products          
                     20.1.2    Variation Application for Health Supplement and Natural Products 
                     20.1.3    Variation Application for Biological Products      

      20.2        Change of Manufacturing Site (COS) (Appendix 31)
      20.3       Change of Product Registration Holder  (Appendix 32)
      20.4        New/ Additional Indication
      20.5        Convenient Pack             

21. POST-MARKETING ACTIVITIES
      21.1        Pharmacovigilance         
      21.2        Post-Market Surveillance            
      21.3        Punitive Action by The Authority              

Announcement

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Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
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