CPM

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 1. Why us?

Navigating the regulatory landscape for Chinese Proprietary Medicines in Singapore can be complex, but with our deep understanding of the local regulatory requirements, we make the process seamless for you. We provide expert consultation and guide you through every step of the registration process, ensuring that your products meet all the necessary compliance standards for the Singapore market.

2.What is a Chinese Proprietary Medicines (CPM)

A Chinese Proprietary Medicine (CPM) is a medicinal product in finished medicinal products such as a capsule or tablet - that contains active ingredients derived from plants, animals or minerals, or any combination of these sources, and is traditionally used in Chinese medicine. It is also commonly known as Traditional Chinese Medicine (TCM). 

What is Not Considered a Chinese Proprietary Medicines (CPM)?

Medicinal products such as injectables, or that contain chemical or biological substances as active ingredients, are not classified as CPM. 

Not Sure if Your Product Qualifies?

Contact us for a free consultation, and we'll help you clarify ​​whether your product is considered a cosmetic under Singapore's regulations. Our regulatory experts will guide you through product classification, notification requirements, and compliance documentation, helping you get to market faster—with confidence.

3. CPM Product Listing

Before selling or supplying CPM in Singapore, you must obtain the respective dealer’s license and product listing approval for each CPM with the Health Sciences Authority (HSA). Without these approvals, commercial distribution is not allowed in Singapore. If you are importing CPM solely for export purposes, a permit is required instead. 

  1. Preparation for Product Listing

Before submitting a product listing application for Chinese Proprietary Medicines (CPM) in Singapore, companies must ensure full compliance with the requirements set by the Health Sciences Authority (HSA). This includes ingredient safety, product labelling, microbial limits, and necessary documentation. 

  • Ingredient Compliance

Ensure that the CPM does not contain:

  1. Synthetic drugs

  2. Potent or toxic substances regulated under the Poisons Act, and naturally occurring substances that exceed permissible limits.

  • Prohibited diseases and conditions

CPM products must not claim to prevent, treat, or cure any of the following 19 diseases or conditions, whether directly or indirectly:

  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

  • Product Labelling Compliance

All labels must be in English. Additional languages (e.g., Chinese) are allowed but must be consistent with the English version.

Product packaging must include the following:

Substances Acceptable Limits / Conditions
Aconite and its alkaloidsDosing of no more than 60 mcg per day.
AmygdalinNo limit.
Berberine, its quaternary compounds and its saltsNo limit.
Boric acid, sodium borateNot more than 5% boric acid or 5% sodium borate or 5% of a combination of both.
Ephedra and its alkaloidsLess than 1%.
Lobelia and its alkaloidsLess than 0.1%.
LovastatinLess than 1%.
MethoxsalenNo limit.
Phenethylamine and its saltsNot more than 300 ppm.
TetrahydropalmatineDosing of no more than 19 mg per day.

Toxic Heavy Metal Heavy Metal Permissible Limit
Arsenic5 parts per million (ppm)
Cadmium0.3 ppm
Lead10 ppm
Mercury0.5 ppm

Oral CPM
Microbes Microbial limits
Total aerobic microbial countNot more than 105 CFU per g or ml
Yeast and mould countNot more than 5 x 102 CFU per g or ml
Escherichia coli, Salmonellae and Staphylococcus aureusAbsent in 1 g or ml
Substance Quantity (by weight)
Diethylene glycol1000 parts per million (ppm)
Ethylene glycol1000 ppm

Topical CPM
Microbes Microbial limits
Total aerobic microbial countNot more than 104 CFU per g or ml
Yeast and mould countNot more than 5 x 102 CFU per g or ml
Escherichia coli, Salmonellae and Staphylococcus aureusAbsent in 1 g or ml
Product Label Items Inner Label Outer Label Package Insert
Trade/ Brand name ☑ ☑ ☑
Product name ☑ ☑ ☑
Batch number ☑ ☑
Expiry date ☑ ☑
Names and quantities of ingredients ☑
This can be included in the outer label if the inner label is small. 		☑
Importer's, wholesaler's, manufacturer's and assembler's name and address ☑
If any. To include additional cautionary clause:
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.
This can be included in the inner label if there is no outer label. 		☑
Manufacturer name and address
Dosage, indication, contraindication and side effects ☑
This can be included in the outer/ inner label if there is no package insert.
Frequency and method of administration ☑
This can be included in the outer/ inner label if there is no package insert.

Special Ingredient Considerations

If the CPM contains materials of ruminant origin (e.g., sheep placenta, gelatin, enzymes, processing aids), ensure proper documentation regarding their use in both active and inactive components.

If the product includes endangered species regulated under the Endangered Species (Import & Export) Act, dealers must obtain permits from the Wildlife Management Group of NParks.

20.Notification Process

Item For imported CPM For local manufactured CPM
1. Labels and package insert used in Singapore ☑ ☑
2. Labels and package insert used in country of manufacture ☑
3. Photograph of CPM content ☑ ☑
4. Manufacturer license ☑
5. Good Manufacturing Practice (GMP) certificate, if any ☑
6. Product registration certificate/ Certificate of Pharmaceutic Product/ Free Sale Certificate ☑
7. Heavy metals and microbial test results ☑ ☑
8. DEG and EG test results (for oral liquid solution with glycerin, propylene glycol, or sorbitol solution) ☑ ☑
9. Manufacturing process description ☑ ☑
10. General quality parameters information (e.g., storage, CoA, specs) ☑ ☑
11. Finished product specifications ☑ ☑
12. Administrative documents such as declaration letter to ensure no western drugs or active synthetic substances ☑ ☑

21 . Post-Notification Process

HSA will screen the product listing dossier for completeness. If any deficiencies are found, an input request will be issued to the applicant.

There is no cost for applying for a product listing with HSA. The turnaround time (TAT) for a new product listing application is 60 working days. The TAT does not include the time taken for the company to respond to the input request.   

4. Fees and Turn-Around Time 

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