How Chinese Proprietary Medicines are regulated by HSA
What are Chinese Proprietary Medicines?
Chinese Proprietary Medicines (CPM) are medicinal products, used according to the traditional Chinese medicine (TCM) system of treatment, that have been manufactured into finished dosage forms such as tablets, capsules and pills. The finished products contain Chinese herbs, animal parts and/or minerals as active ingredients.
How are CPM regulated in Singapore?
There are regulations in place to ensure the safety and quality of CPM in Singapore:
- CPM Dealer's Licence - All local dealers (i.e. manufacturers, importers, wholesalers and re-packers) must be licensed by HSA.
- CPM Product Listing - Dealers must also apply for product listing approval for each CPM before they can import, manufacture and/or sell the products in Singapore. To get listed, the CPM must meet the safety and quality requirements specified by HSA. For example, the products must not contain any potent/toxic substances controlled under the Poisons Act, synthetic chemical compounds found in western medicines, toxic heavy metals and microbial contents exceeding the permissible limits.
- Product Labels - All CPM must have English labels which include important information such as product name, batch number, expiry date, active ingredients, and dosage.
- Prohibited Claims - Labels for CPM are not allowed to make claims for treating a specified list of serious medical conditions, including cancer and diabetes.
- Adverse Events Reporting - Manufacturers, importers and wholesalers must report adverse events to HSA.
There is a post-market surveillance programme to monitor the safety of CPM. There are two components to this:
- Risk-based surveillance - Sampling and testing of products found in the market.
- Adverse reaction monitoring - Draws on HSA’s network of local healthcare professionals and international regulatory partners to pick up signals of any health products that may be causing adverse reactions.
This system of checks and controls has enabled HSA to initiate timely recalls of harmful and inferior quality products.
If you suspect that the product you are taking is making you unwell or causing side effects, please consult a medical professional and bring along the product.