Regulatory overview of Chinese Proprietary Medicines

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).

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

Watch CPM labelling video

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.

Bilingual Reference List for Herbal Ingredients in CPM Preparations

A comprehensive bilingual reference list of common CPM ingredients has been developed to help applicants in their preparation of product labels, especially for single-ingredient CPM preparations.

The list includes standardised English and Chinese names, intended use, dosage and cautionary statements for each ingredient.

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 guideline.

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

Your product must not exceed the following:

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.

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

Oral CPM

Topical CPM

Oral liquid CHPs must not exceed the following:

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 guidelines to minimise the risk of TSE transmission.

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.

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.