Regulatory overview of Chinese Proprietary Medicines

Understand the requirements to import, wholesale, manufacture or assemble Chinese Proprietary Medicines in Singapore.

What is a Chinese Proprietary Medicine

In Singapore, a Chinese Proprietary Medicine (CPM) refers to a medicinal product that:

  • Is in the form of a finished product, such as a capsule or tablet, and
  • Contains one or more active ingredients from any plant, animal or mineral, or any combination of sources. All of the active ingredients have to be documented for use in traditional Chinese medicine.

The following are not considered as CPM:

  • Products to be injected into the human body.
  • Products containing any chemically-defined isolated constituents as an active ingredient.

Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB 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.

Regulatory requirements of CPM

You will need to have a product listing approval and a dealer's licence to import, wholesale, manufacture or assemble CPM for sale and supply in Singapore.

If you are importing the CPM solely for export, product listing and dealer licences are not required, but you will need to apply for a permit for the import of CPM solely for re-export.

Prohibited ingredients

Prohibited ingredients

CPM manufactured or imported and sold here cannot contain these substances:

  • Synthetic drugs.
  • Substances listed in the Poisons Act, except for the list of allowable naturally occurring substances within limits (see below).

Limits for naturally occurring substances

Limits for naturally occurring substances allowed in CPM

A CPM may contain the following naturally occurring substances within the stated acceptable limits and conditions.

Substances Acceptable limits or conditions
Aconite and its alkaloids Dosing of no more than 60 mcg per day.
Amygdalin No limit.
Berberine, its quaternary compounds and its salts No limit.
Boric acid, sodium borate Not more than 5% boric acid or 5% sodium borate or 5% of a combination of both.
Ephedra and its alkaloids Less than 1%.
Lobelia and its alkaloids Less than 0.1%
Lovastatin Less than 1%.
Methoxsalen No limit.
Phenethylamine and it's salts Not more than 300ppm.
Tetrahydropalmatine Dosing of no more than 19 mg per day.

Labelling requirements

Labelling requirements

Full labelling in English is required for all CPM. Chinese or other languages, if any, may be used in addition to English. The information in languages other than Chinese and English, if applicable, should be the same as the English version of the approved labels.

Self-Help Checklist for Key Labelling Information for CPM 

As a guide for applicants to take note of what are the common CPM labelling errors, a checklist can be found here for applicants to refer to and check that the necessary details are included, before submitting the product labels.

Inner label

The inner label must state:

  • Trade or brand name.
  • Product name.
  • Batch number.
  • Expiry date.
  • Names and quantities of ingredients.
    • If inner label is too small, the information may be stated on the outer label.

Outer label

The outer label must state:

  • Trade or brand name.
  • Product name.
  • Batch number.
  • Expiry date.
  • Importer's, wholesaler's, manufacturer's and assembler's (if any) name and address.
  • "Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。".
    • The words must be clearly legible and printed in an indelible manner.
    • The English words should not be less than 1.5mm in height and the Chinese characters not less than 2mm in height.
    • The words must be enclosed in a boxed area and clearly visible. Nothing else should appear in this boxed area.
    • The label must appear conspicuously in a prominent position.

Note: If there is no outer label, the information above must be stated in the inner label.

Package insert

The package insert must state:

  • Trade or brand name
  • Product name.
  • Manufacturer's name and address.
  • Names and quantities of ingredients.
  • Dosage, indication, contraindication and side effects.
  • The frequency and method of administration.

Note: If there is no package insert, the information above must be stated either in the inner label or outer label.

Guidelines on Electronic Labelling (E-labelling)

E-labelling refers to product information which is distributed via electronic means, such as through a machine-readable code (e.g. QR code) or URL on the product packaging, linking to product information in digital format. Presently, e-labelling for CPM is applicable to the product leaflet only.

Dealers who are interested to use e-labelling for their CPM have to inform HSA. For more details, please refer to this guideline240 KB.

Prohibited diseases and conditions

You are not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following 19 diseases and 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

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

Dealers may wish to take note of the following suggestions in controlling the heavy metal contents of their products:

  • Identify starting materials (e.g. certain herbs, minerals) that may contribute to higher heavy metal content in their product;
  • Source for starting materials which have been tested to contain heavy metals below stipulated limits;
  • Ensure that herbal materials are free from soil particles before use (e.g. by washing thoroughly, if applicable); and
  • Incorporate relevant extraction processes in the manufacturing workflow to remove heavy metals in the product, if necessary.

Microbial limits

Microbial limits

CPM must be tested to comply with the following microbial count:

Oral CPM

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 CPM

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

Diethylene glycol and ethylene glycol limits

Diethylene glycol and ethylene glycol limits

Oral liquid CHPs must not exceed the following diethylene glycol and ethylene glycol limits:

SubstanceQuantity (by weight)
Diethylene glycol1000 parts per million (ppm)
Ethylene glycol1000 ppm


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 guidelines236 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.