The National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health Malaysia, is responsible for the registration, review, quality management, supervision and regulatory governance of health supplements in Malaysia.
Official Website of the Regulatory Authority: https://npra.gov.my/
Database Portal: https://quest3plus.bpfk.gov.my/pmo2/index.php
Drug Registration Guidance Document (DRGD)
Control of Drugs and Cosmetics Regulations 1984 (CDCR)
Health supplements in Malaysia are defined as products intended to supplement the diet and maintain human health, usually presented in the forms of capsules, tablets, powders and liquids, excluding sterile preparations.
They are categorised into three classes based on the risk level of their claims: ① General or Nutritional Claims ② Medium risk: Functional Claims ③ High risk: Disease Risk Reduction Claims
Core determination logic for food-medicine boundary：A product is classified as a medicine if it contains prohibited substances, bears medicinal or health claims, or adopts medicine-type packaging forms. Products that meet none of the above conditions are classified as food.
Power of Attorney issued by the manufacturer
Certificate of Pharmaceutical Product (CPP) issued by the competent authority of the country of origin. Certificates issued by the Australian TGA, National Administration of Traditional Chinese Medicine of China, European Commission, Health Canada and the U.S. FDA are given priority recognition
In the absence of a CPP, a Certificate of Free Sale (CFS) issued by the competent authority of the country of origin / the country of the product owner, together with a Good Manufacturing Practice (GMP) certificate, shall be provided
Importer information and complete product description
Technical documentation including Certificate of Analysis (COA) for finished products, COA for active ingredients, stability data, packaging and labelling test reports, and process control documents
Overseas manufacturers must appoint a locally registered commercial company in Malaysia as the holder of the registration certificate, who shall be responsible for communication with the NPRA.
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Product Information: Product name, dosage form (capsules, tablets, powders, liquids, etc., non-sterile preparations), ingredient composition (qualitative and quantitative, including active ingredients and excipients), intended use / indications, labelling and packaging information.
Manufacturing Information: Manufacturing process flow chart, GMP certificate (the manufacturer shall comply with GMP requirements), specifications for raw materials and finished products, quality control (in-process QC and finished product QC), analytical methods and validation, and Certificates of Analysis (COA) for finished products and raw materials.
Stability Data: Stability studies supporting the shelf life of the product.
Safety and Efficacy Data: Safety evidence for active ingredients (new ingredients require more supporting data, such as GRAS status, scientific literature or clinical data), and toxicological data (as applicable).
Other Documentation: Product classification confirmation, information of the holder / manufacturer / importer, patent / data exclusivity declaration, declaration of animal-derived ingredients and corresponding labelling requirements (e.g. Halal certification, etc.).
Pursuant to the Control of Drugs and Cosmetics Regulations 1984, all registered health supplements must be affixed with a holographic anti-counterfeiting mark, which is exclusively supplied by Techno Secure Print Sdn Bhd at a unit price of RM0.064 per piece.
1.Registration Procedure
Preparation Phase: Product classification confirmation, token configuration, payment method setup, verification of patent and data exclusivity, and preparation of key documentation.
Submission Phase: Online entry of information via the QUEST system, with application documents uploaded in four sections.
Regulatory Review Phase: Technical assessment by the NPRA → final decision by the Drug Control Authority (DCA).
Post-Registration Phase: Maintenance of registration information, modification of product information, product delisting, and post-marketing surveillance activities.
2.Official Review Timeline
Bridging assessment timeline: 116 working days for products with a single active ingredient; 136 working days for products with two or more active ingredients.
Expedited assessment timeline: 7-14 working days (for applications with complete and compliant documentation).
3.Official Fees
Health supplement registration processing fee: RM2,000 per product
Expedited assessment fee: RM300 per product per application