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