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Malaysia NPRA: Guidance on Drug Registration

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration" which details the process of registering pharmaceutical drugs as a vital step in ensuring the safety, efficacy, and quality of medications available in the market.

Drug Registration Guidance Document (DRGD) serves as a comprehensive reference for pharmaceutical companies seeking to register their drugs in Malaysia. It lays out a systematic framework and clear guidelines that streamline the registration process, ensuring all necessary requirements are met.

The scope of this DRGD includes information relating to administrative requirements and procedures for:

  1. Submission of an application for the registration of medicinal products, which is based on the ASEAN Common Technical Dossier/ Requirements (ACTD/ ACTR), where applicable;

  2. Submission of an application for the licensing of manufacturers, importers, and wholesalers;

  3. Submission for amendments to a registered medicinal product;

  4. Post-registration activities.

This DRGD contains five (5) Main Sections and thirty-three (33) Appendices. The main sections are :

  • Section A: General Overview

  • Section B: Product Registration Process

  • Section C: Quality Control

  • Section D: Inspection, Licensing, Certificate

  • Section E: Post-Registration Process

The type of application for product registration depends on the category as specified in the respective appendix:

  • Appendix 3: Guideline on Registration of New Drug Products

  • Appendix 4: Guideline on Registration of Biologics

  • Appendix 5: Guideline on Registration of Generics

  • Appendix 6: Guideline on Registration of Health Supplements

  • Appendix 7: Guideline on Registration of Natural Products

    • Appendix 7A: Homeopathic Products

    • Appendix 7B: Guideline on Natural Products with Therapeutic Claim

It is important to consider factors such as when registering a product:

  • Knowing which type of application to apply for;

  • Knowing which evaluation route to choose;

  • Arranging for a Pre-Submission Meeting (PSM) with NPRA for advice, if required.

Click this LINK to download the complete DRGD with Appendices.


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