Agency Profile

National Pharmaceutical Regulatory Agency (NPRA)

The primary authority responsible for quality, safety, and efficacy of pharmaceuticals and cosmetics in Malaysia.

About the NPRA

Formerly known as the National Pharmaceutical Control Bureau (NPCB), the NPRA acts as the secretariat to the Drug Control Authority (DCA). It enforces the Control of Drugs and Cosmetics Regulations 1984. Every pharmaceutical product, health supplement, and traditional medicine must be registered with the NPRA before entering the Malaysian market.

Key Regulated Categories

Pharmaceuticals
NCEs, Generics, Biologics
Cosmetics
Notification Process
Health Supplements
Vitamins, Minerals
Traditional Medicine
Herbal Preparations
Visit Official NPRA Website

Navigating Quest3+

The Quest3+ system is the mandatory online submission portal for all NPRA product registrations. A digital certificate token is required for access.

Our Quest3+ Services

  • 🔐
    Account Registration

    First-time setup and USB token acquisition.

  • 📂
    Dossier Compilation

    ACTD/ICH format preparation for submission.

  • 💬
    Query Management

    Handling deficiency letters and appeals.