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, Seventh Revision January 2024 (Main body) Jan 2024
Appendix 1 : Food Drug Interphase (FDI) Products Jan 2024
Appendix 2 : Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products Jan 2024
Appendix 3 : Guideline on Registration of New Drug Products Jan 2024
Appendix 4 : Guideline on Registration of Biologics Jan 2024
Appendix 5 : Guideline on Registration of Generics Jan 2024
Appendix 6 : Guideline on Registration of Health Supplements Jan 2024
Appendix 7 : Guideline on Registration of Natural Products Jan 2024
Appendix 7A : Homeopathic Products  Jan 2024
Appendix 7B : Guideline on Natural Products with Therapeutic Claim Jan 2024
Appendix 8 : Supplementary Documentation (Particulars of Product Owner and Manufacturer) Jan 2024
Appendix 9 : Fees Jan 2024
Appendix 10 : Data Exclusivity  Jan 2024
Appendix 11 : Regulatory Control of Active Pharmaceutical Ingredients (APIs) Jan 2024
Appendix 12 : Priority Review Jan 2024
Appendix 13 : Designation and Registration of Orphan Drugs Jan 2024
Appendix 14 : Evaluation Routes  Jan 2024
Appendix 15 : Requirements for Full Evaluation and Abridged Evaluation Jan 2024
Appendix 16 : Bioequivalence (BE) Requirements Jan 2024
Appendix 17 : Product Names Not Permitted to Be Registered Jan 2024
Appendix 18 : List of Permitted, Prohibited and Restricted Substances Jan 2024
Appendix 19 : General Labelling Requirements Jan 2024 
Appendix 19A : Prohibited Visual/ Graphics/Statements on Label Jan 2024
Appendix 20 : Specific Labelling Requirements Jan 2024 
Appendix 21 : Special Conditions for Registration of a Particular Product or Group of Products Jan 2024 
Appendix 22 : Educational Materials Jan 2024 
Appendix 23 : Patient Dispensing Pack for Pharmaceutical Products  Jan 2024 
Appendix 24 : Appeal Jan 2024 
Appendix 25 : Guideline for the Submission of Protocol of Analysis (POA) Jan 2024 
Appendix 26 : Guideline for the Submission of Analytical Method Validation (AMV) Documents Jan 2024 
Appendix 27 : Inspection Jan 2024 
Appendix 28 : Licensing Jan 2024 
Appendix 29 : Certificate Jan 2024 
Appendix 30 : Change of Manufacturing Sites (COS) Jan 2024 
Appendix 31 : Change of Product Registration Holder (COH) Jan 2024 
Appendix 32 : Explanatory Notes for Repackers Jan 2024 
Appendix 33 : Guideline on Safety Data Requirements for Complementary Medicine Products Jan 2024 

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 the 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 for 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

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 30)
      20.3       Change of Product Registration Holder (COH)  (Appendix 31)
      20.4        New/ Additional Indication
      20.5        Convenient Pack             

21. POST-MARKETING ACTIVITIES
      21.1        Pharmacovigilance         
      21.2        Product Quality Monitoring (PQM)
                     21.2.1    Product Quality Monitoring (PQM) Programme
                     21.2.2    Product Sampling
                     21.2.3    Product Testing
                     21.2.4    Monitoring of Label Compliance
                     21.2.5    Product Quality Reporting
                     21.2.6    Risk Communication on Information of Product Issues
                     21.2.7    Regulatory Action
                     21.2.8    Adulteration           

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