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Drug Registration Guidance Document

Cover of the Drug Registration Guidance Document, July 2026 edition
Drug Registration Guidance Document — the current edition, July 2026.

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:
  • The written laws shall take precedence over this guidance document in any event of discrepancy.

The DRGD shall be read in conjunction with, and is subordinate to, the following legislation:

  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).

Issued under Regulation 29

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

July 2026

Download the DRGD

The complete document, the main body on its own, and the directive that issued this revision. Individual appendices are listed below.

Complete DRGD, with all appendices

3rd Edition, 12th Revision · 3.9 MB

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Main body only, without appendices

3rd Edition, 12th Revision · 1.3 MB

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Directive No. 18/2026

Issuing directive · 292 KB

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Appendices

39 documents. Each opens as a PDF.

Revision history

What changed in each revision, and the superseded editions.

DRGD table of contents

What each section of the guidance document covers. Open a section to see its 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 Biological Products
  • 20.1.3 Variation Reliance (for pharmaceutical and biological products only)
  • 20.1.4 Variation Application for Health Supplement and Natural Products
  • 20.1.5 Variation Timeline
  • 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

Announcement

Notices to product registration holders, newest first.

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