Regulatory overview of traditional medicines

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

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.

If you are unsure of your product's classification, you can check using our Complementary Health Products (CHP) Classification Tool to assist you in the classification of common CHP.

Regulatory requirements of TM

TM 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 TM into Singapore.

Toxic heavy metal limits

Toxic heavy metal limits

Your product must not exceed the following heavy metal limits:

Heavy metal Permissible limits
Arsenic 5 parts per million (ppm)
Cadmium 0.3ppm
Lead 10ppm
Mercury 0.5ppm


Note:
 For existing products imported or locally manufactured before 1 September 2019, dealers will have a one-year grace period to ensure compliance to the above revised limits. With effect from 1 September 2020, all products sold in Singapore should not exceed the revised limits.

Microbial limits

Microbial limits

Your product must not exceed the following microbial limits:

Oral products 

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 

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 10CFU 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: http://asean.org/asean-economic-community/sectoral-bodies-under-the-purview-of-aem/standards-and-conformance/policy-and-guidelines.

Labelling requirements

Labelling requirements

Your product label should include the ingredients and their strengths in English. 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. 

Prohibited ingredients

Prohibited ingredients

TM manufactured or imported and sold here cannot contain these ingredients or substances:

  • Amygdalin, pangamic acid or its salts, danthron, suprofen or its salts and rhodamine B.
  • Synthetic drugs.
  • Substances listed in the Poisons List of the Poisons Act.
  • Ingredients listed under the ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines.

Transmissible Spongiform Encephalopathy (TSE)

Animal derived ingredients

Transmissible spongiform encephalopathy (TSE) refers to a group of progressive diseases including scrapie in sheep and goats, chronic wasting disease in mule, deer and elk, bovine spongiform encephalopathy (BSE) in cattle, as well as Kuru and Creutzfeldt-Jakob Disease (CJD) in humans.

The infectious agents causing these diseases replicate and cause neurological disorders and eventual death in the infected individuals. There are currently no early diagnostic tests or known therapies for these diseases.

If your product contains animal derived ingredients, you must comply with our TSE guidelines107 KB to minimise the risk of TSE transmission.

Substances from endangered species

Substances from endangered species

If your product contains substances from endangered species listed under the Endangered Species (Import & Export) Act, you should contact the Wildlife Management Group of NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.

Advertisements and promotions

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.

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