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Health Sciences Authority

Regulatory overview of traditional medicines

Understand the requirements to import, manufacture or sell traditional medicines in Singapore.

Last updated 25 May 2026

What is a traditional medicine

In the local context, traditional medicines (TM) refer to Malay and Indian traditional medicinal products. They are finished products containing ingredients with uses documented in relevant TM references.

Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree for more information.

Is my product a complementary health product (CHP)?

Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g. Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore. You can also get a print-out of your product classification outcome from the tool.

Let's go

Want to know more about CHP product classification? Click here for our FAQ.

Controls on traditional medicines

Traditional medicines are not subject to approvals and licensing by HSA for their importation, manufacture and sale. HSA prohibits the addition of medicinal ingredients such as steroids in TM. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying traditional medicines into Singapore.

Dealers may voluntarily notify HSA of their traditional medicines supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. Click here for more information.

A list of questions and answers on safety, quality and labelling of traditional medicines can be found here.

Safety and quality standards

As a dealer of traditional medicines, you must ensure your products conform with our safety and quality standards.

Substances not allowed

Traditional medicines that are imported or sold must not contain the following:

  • Synthetic drugs.

  • Ingredients controlled and prohibited under the Poisons Act (Chapter 234) and Poisons Rules, Misuse of Drugs Act (Chapter 185) and its Regulations, and the ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).

  • Ingredients derived from human parts.

  • Ingredients that may affect the human health (see Guidelines for Establishing Safety of Ingredients for more information).

  • Ingredients that contain agents that can lead to animal-transmissible diseases such as Transmissible Spongiform Encephalopathy (TSE). The guidelines on minimising the risk of TSE are available at: TSE Guidelines

  • Ingredients regulated under the Endangered Species (Import & Export) Act, unless permitted. Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) import permit is needed from NParks.

  • Active substances that are not stated on the label.

Some substances have the potential to cause adverse health effects or safety concerns when used in health supplements and traditional medicines, and hence should be used with specific restrictions or conditions such as maximum daily dose limits or labelling specifications.

Please refer to the Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines for more information.

Toxic heavy metal limits

Your product must not exceed the following:

List of permissible heavy metal limits

Heavy metal

Permissible limits

Arsenic

5 parts per million (ppm)

Cadmium

0.3ppm

Lead

10ppm

Mercury

0.5ppm

Microbial limits

Your product must not exceed the following microbial limits:

Oral products 

List of microbe and microbial limits

Microbe 

Microbial limits 

Total aerobic microbial count

Not more than 105 CFU per g or ml 

Yeast and mould count

Not more than 5 x 102 CFU per g or ml

Escherichia coli, Salmonellae and Staphylococcus aureus

Absent in 1g or ml

Topical products 

List of microbe and microbial limits

Microbe

Microbial limits 

Total aerobic microbial count

Not more than 104 CFU per g or ml

Yeast and mould count

Not more than 5 x 102 CFU per g or ml

Pseudomonas aeruginosa and Staphyloccocus aureus

Absent in 1g or ml

Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users. Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. The applicable guidelines is posted at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).

Diethylene glycol and ethylene glycol limits

Oral liquid CHPs must not exceed the following:

Diethylene glycol and ethylene glycol limits

Substance

Quantity (by weight)

Diethylene glycol

1000 parts per million (ppm)

Ethylene glycol

1000 ppm

Quality standards

Your product needs to achieve acceptable standards of quality in terms of:

  • Product stability and shelf life   

  • Storage conditions and distribution practices

  • Manufacturing, packaging and assembly conditions

Please refer to the following guidelines for more information: 

Labelling standards

Your product label should be prominent and conspicuous. Its information in English should be adequate and truthful. The label should contain the following:

  • Product Name (including Brand Name, if any)

  • Dosage Form

  • Name and Quantity of Active Ingredients

  • Product Indications / Intended Purpose

  • Dosage and Directions of Use

  • Batch Number

  • Expiry Date 

  • Country of Manufacture

  • Name and Address of Local Importer (for overseas manufactured product) or Product Owner (for locally manufactured product)

  • Contraindications, if any

  • Other Warnings, if any

  • Storage Condition

  • Pack Size / Net Content

Please refer to the labelling standards guidelines for more information.

Traditional medicines claims

Please note that you are also not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following conditions:

  1. Blindness

  2. Cancer

  3. Cataract

  4. Drug addiction

  5. Deafness

  6. Diabetes

  7. Epilepsy or fits

  8. Hypertension

  9. Insanity

  10. Kidney diseases

  11. Leprosy

  12. Menstrual disorder

  13. Paralysis

  14. Tuberculosis

  15. Sexual function

  16. Infertility

  17. Impotency

  18. Frigidity

  19. Conception and pregnancy

Dealers must ensure that all health claims and information associated with the products are sufficiently supported and submitted to HSA as and when required. Otherwise, all unsubstantiated health claims and information will be considered misleading and must be removed from the product materials. Please refer to the Guidelines for Claims and Claim substantiation, as well as the List of Health Claims for more information.

Training materials

You may refer to the training materials for the expected safety, quality, and labelling standards for Health Supplements (HS) and Traditional Medicines (TM).

Advertisements and promotions

You will require a valid permit from us before publishing any medical advertisements or conducting any sales promotion activities directed to the general public.

Refer to our advertisements and promotions guidelines for more information on what is required before you run any advertisements and promotions for your products.

Free Sale Certificate (FSC)

Some importing countries may require a certificate to show that the product is currently sold and distributed in Singapore.

As such, local exporters may apply for a FSC from the Health Sciences Authority.

Each FSC is specific to one product and allows the inclusion of up to five importing countries. Information in the FSC includes:

  1. Name of product

  2. Importing countries

  3. Name and address of the manufacture(s) and distributor(s)

  4. Intended use

  5. Ingredients

  6. Date of Issue of the FSC

With effect from 25 March 2026, HSA will be issuing verifiable electronic certificates for exporters (including Certificate of a Pharmaceutical Product and Free Sale Certificate) using GovTech's FileSG digital platform. FileSG will replace TrustDocs for issuance of verifiable electronic documents. There will not be any changes to the application fees for these certificates. For further information, please refer to the HSA Frequently Asked Questions on Migration of TrustDocs to FileSG.