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:
Submission of an application for the registration of medicinal products, which is based on the ASEAN Common Technical Dossier/ Requirements (ACTD/ ACTR), where applicable;
Submission of an application for the licensing of manufacturers, importers, and wholesalers;
Submission for amendments to a registered medicinal product;
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.