Malaysia Pharmaceutical Regulatory Pathway
[Tuesday, 7th Nov 2023]
Malaysia Pharmaceutical Regulatory Pathway
Nithiyaraj Rajalingam
NVS Regulatory Services

Malaysia has a maturing pharmaceutical regulatory landscape for the past 45 years now since the establishment of National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB).

From the initial of only several product categories being registered, it has evolved to many more now with streamlining of requirements for each category by NPRA.

In this presentation, we provide an overview of the pharmaceutical product registration process in Malaysia, its different categories of product registration and timelines associated with each category. We also discuss briefly on the bare minimum requirements by NPRA for each product registration category.


1. Introduction to NPRA and its role

2. Overview of pharmaceutical product registration process in Malaysia

3. The different product registration categories in Malaysia and example of products for each category

  • New Drug Products

  • Biologics/Biosimilar

  • Generic (Scheduled Poison/Non-scheduled Poison)

  • Health Supplement

  • Natural Products (Herbal/Traditional)

  • Veterinary Products

  • Cosmetic (Notification)

4. Timelines for registration/notification

5. Brief discussion on the bare minimum requirements of each category

Nithiyaraj Rajalingam
Regulatory Affairs Consultant and Founder at NVS Regulatory Services
Mr. Nithiya Raj is a pharmacist based in Malaysia. He is a distinguished professional with a remarkable 14-year career in pharmaceutical field guiding many foreign pharmaceutical companies to registering their pharmaceutical products in Malaysia. His portfolio boasts the successful registration of countless generics and specialist drugs. In 2017, he embarked on a journey as an entrepreneur, founding his consultancy company, NVS Regulatory Services. Today, it offers regulatory services in Malaysia and Singapore, supported by a talented team of 5+ regulatory consultants.
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