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Topic:傳統藥
All articles tagged “傳統藥”, aggregated across product categories, compiled from official sources.
Malaysia Traditional Medicine GMP: Manufacturer's Licence and Audit Explained
To be legally marketed in Malaysia, a traditional medicine's factory must first pass NPRA's GMP audit and obtain a manufacturer's licence. This article explains the legal basis, core chapters, application process and common mistakes.
Malaysia Traditional Medicine Heavy-Metal and Microbial Limit Standards
Finished traditional medicines must pass NPRA's heavy-metal and microbial testing before registration. This article sets out the limits for lead, arsenic, mercury and cadmium, the microbial limits for oral dosage forms, contamination sources and key testing points.
Malaysia Poisons List: The Group A/B/C/D Classification Lines
The First Schedule of the Poisons Act 1952 divides ingredients into Groups A, B, C and D, deciding whether a product needs a prescription, where it can be sold, and whether it is a prescription medicine or OTC. This line is the starting point for brands and importers judging the registration category.
Malaysia OTC Medicines (Category X): A Registration Guide
Products with a MAL number ending in X are over-the-counter (OTC) medicines containing non-scheduled poison ingredients outside the First Schedule of the Poisons Act 1952. This article explains the definition of Category X, how it differs from A/T/N, which products must register as X, and the labelling duties.
Malaysia Medicine Renewal and Variation: The 5-Year Term and Variation Explained
Malaysian product registration has a 5-year validity period and must be renewed on expiry; changes to the label, packaging, factory address and so on must first go through a Variation. This article explains the judgement principles, the Quest process and common mistakes.
Malaysian Herbal Teas and Wellness Drinks: Food or Traditional Medicine?
The very same pack of herbal tea may be regulated by the Ministry of Health's Food Safety and Quality Division (FSQD) as a food, or treated by the National Pharmaceutical Regulatory Agency (NPRA) as a finished herbal product requiring registration and a MAL number. The dividing line lies in ingredient ratios, dosage instructions and therapeutic claims — not in what the product is called.
Classification and Registration of Topical Pain-Relief Liquids / Essential-Oil Balms (Malaysia)
Are medicated oils, rheumatism oils, and essential-oil balms cosmetics or traditional medicine in Malaysia? It comes down to therapeutic claims and active ingredients. This article clarifies the three classification boundaries, DRGD ingredient limits, and NPRA registration essentials.
Compliance for Importing Chinese Medicine / Chinese Proprietary Medicine into Malaysia (Malaysia)
To import Chinese medicine and Chinese proprietary medicine into Malaysia for sale, each product must first be registered with NPRA to obtain a MAL(T) number and be handled by a company holding an Import Licence. This article breaks down the two gates of registration vs. import and the ingredient red lines.
Medicine / Traditional Medicine Advertising Permit KKLIU (Malaysia)
In Malaysia, any medicine — including prescription drugs, over-the-counter (OTC) medicines and traditional medicines — must obtain a KKLIU advertising permit from the Ministry of Health's Medicine Advertisements Board (MAB) before advertising to the general public. Here is the scope, the special points for traditional-medicine ads, the prohibited disease claims and the penalties.
Traditional Medicines Adulterated with Western Drugs: Risks, Enforcement and Recalls (Malaysia)
The biggest risk with traditional medicines seized on the Malaysian market is covert adulteration with Western drugs — steroids, sibutramine, sexual-enhancement ingredients, etc. The NPRA regularly issues adulteration alerts, cancels registrations and removes products from sale. Here are the common adulterants, the recall mechanism and how sellers protect themselves.
NPRA Registration for Medicated Plasters / Patches (Malaysia)
Pain-relief patches and medicated plasters are classified as traditional medicine in Malaysia and must be registered with NPRA to obtain a MAL(T) number and carry a Meditag security label. This article breaks down the classification boundaries, registration process, and import essentials.
Drug Classification Map: How Western Medicine / Traditional Medicine / Supplements Are Distinguished (Malaysia)
In Malaysia, the same capsule could be classified as a Western medicine, a traditional medicine or a health supplement — which determines the registration category, the ending letter of the MAL number and the sales channel. Use one map to understand how the NPRA classifies by ingredient, dosage form, claim and the Poisons Act 1952.