Frequently Asked Questions

A MAL number (e.g., MAL20123456T) is the registration approval issued by the Drug Control Authority (DCA). It allows you to legally import, distribute, and sell pharmaceutical, traditional, or supplement products in Malaysia. Selling unregistered products is a serious offense under the Sale of Drugs Act 1952.

Timelines vary by product category (according to NPRA/MDA client charters):

• Cosmetic Notification: 1-3 working days.
• Generic Drugs: 12-18 months.
• New Drugs (NCE): 18-24 months.
• Traditional Medicines: 6-9 months.

Note: These are evaluation timelines after full dossier submission.

Common reasons include:

• Incomplete Administrative (Part I) or Quality (Part II) data.
• Presence of banned or adulterated substances.
• GMP status of the manufacturer is not recognized by NPRA.
• Therapeutic claims not substantiated by clinical evidence.

ARCI can conduct a gap analysis to rescue rejected or stalled applications.

Yes. Foreign companies must appoint a local Malaysian company as the Product Registration Holder (PRH). ARCI can act as your PRH, holding the license on your behalf while you retain full ownership of the product rights.

Official NPRA processing fees include:

• Cosmetic Notification: RM 50 per product.
• Traditional Product: RM 500 processing + RM 700 analysis.
• Pharmaceuticals: RM 1,000 - RM 3,000+ depending on category.

ARCI consultancy fees are separate and cover dossier compilation, submission management, and agency liaison.

Most product registrations (Drugs, Traditional, Supplements) are valid for 5 years. Cosmetic notifications are valid for 2 years. Renewal applications should be submitted 6 months prior to expiry to avoid business disruption.