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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:
- Sale of Drugs Act 1952;
- Control of Drugs and Cosmetics Regulations 1984;
- Dangerous Drugs Act 1952;
- Poisons Act 1952;
- Medicines (Advertisement & Sale) Act 1956;
- Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
- International Trade in Endangered Species Act 2008 (Act 686).
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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.
DRGD Appendices
| Document Name | Updated |
|---|---|
| Drug Registration Guidance Document (DRGD), 3rd Edition, Third Revision July 2022 (Main body) | July-2022 |
| Appendix 1 : Food Drug Interphase (FDI) Products | July-2022 |
| Appendix 2 : Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products | July-2022 |
| Appendix 3 : Guideline on Registration of New Drug Products | July-2022 |
| Appendix 4 : Guideline on Registration of Biologics | July-2022 |
| Appendix 5 : Guideline on Registration of Generics | July-2022 |
| Appendix 6 : Guideline on Registration of Health Supplements | July-2022 |
| Appendix 7 : Guideline on Registration of Natural Products | July-2022 |
| Appendix 7A : Homeopathic Products | July-2022 |
| Appendix 7B : Guideline on Natural Products with Therapeutic Claim | July-2022 |
| Appendix 8 : Supplementary Documentation (Particulars of Product Owner and Manufacturer) | July-2022 |
| Appendix 9 : Fees | July-2022 |
| Appendix 10 : Data Exclusivity | July-2022 |
| Appendix 11 : Regulatory Control of Active Pharmaceutical Ingredients (APIs) | July-2022 |
| Appendix 12 : Priority Review | July-2022 |
| Appendix 13 : Designation and Registration of Orphan Drugs | July-2022 |
| Appendix 14 : Evaluation Routes | July-2022 |
| Appendix 15 : Requirements for Full Evaluation and Abridged Evaluation | July-2022 |
| Appendix 16 : Bioequivalence (BE) Requirements | July-2022 |
| Appendix 17 : Product Names Not Permitted to Be Registered | July-2022 |
| Appendix 18 : List of Permitted, Prohibited and Restricted Substances | July-2022 |
| Appendix 19 : General Labelling Requirements | July-2022 |
| Appendix 19A : Prohibited Visual/ Graphics/Statements on Label | July-2022 |
| Appendix 20 : Specific Labelling Requirements | July-2022 |
| Appendix 21 : Special Conditions for Registration of a Particular Product or Group of Products | July-2022 |
| Appendix 22 : Educational Materials | July-2022 |
| Appendix 23 : Patient Dispensing Pack for Pharmaceutical Products | July-2022 |
| Appendix 24 : Appeal | July-2022 |
| Appendix 25 : Guideline for the Submission of Protocol of Analysis (POA) | July-2022 |
| Appendix 26 : Guideline for the Submission of Analytical Method Validation (AMV) Documents | July-2022 |
| Appendix 27 : Inspection | July-2022 |
| Appendix 28 : Licensing | July-2022 |
| Appendix 29 : Certificate | July-2022 |
| Appendix 30 : Change of Manufacturing Sites (COS) | July-2022 |
| Appendix 31 : Change of Product Registration Holder (COH) | July-2022 |
| Appendix 32 : Explanatory Notes for Repackers | July-2022 |
| Appendix 33 : Guideline on Safety Data Requirements for Complementary Medicine Products | July-2022 |
List of DRGD Updates
DRGD Table of Contents
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)
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)
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)
16. LICENSING (Appendix 28)
17. CERTIFICATE (Appendix 29)
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 Post-Market Surveillance
21.3 Punitive Action by the Authority
21.4 Notification of Product Quality Issue
