An introduction to registration requirements of Chinese Proprietary Medicines(CPM) in Singapore


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Chinese Proprietary Medicines(中成药产品)  refers to finished medicinal  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 the active ingredients must be documented for use in traditional Chinese medicine.

Prior to importation and distribution of CPM in Singapore, CPM must undergo a product listing approval process.

A brief outline of the registration requirements, processing timeline and fees are presented below:

Documentary requirements for imported products are listed below:

  1. Labels of product to be sold including including inner label, outer carton and package insert
  2. Photograph of the product’s contents.
  3. Labels of product sold/supplied in country of manufacture including inner label, outer carton and package insert
  4. Manufacturer’s Licence or certificate
  5. Good Manufacturing Practice (GMP) certificate if any
  6. Product registration certificate (if applicable)
  7. Free sale certificate of equivalent from country of manufacture
  8. Test results of toxic heavy metals and microbial contamination
  9. Storage condition/containers
  10. Quality parameters for CPM products
  11. Endorsement of product formula (including all active and inactive ingredients) by overseas manufacturer and undertaking by overseas manufacturer that product does not contain any Western drugs or active synthetic substance
  12. Information on legal classifications of product in countries of sales
  13. Website undertaking – for products with website stated on label(s)
  14. TSE undertaking – for products containing materials (including those used for making capsule shells) derived from ruminants (e.g. cattle, buffalo, sheep, goat, deer, antelope)
  15. Info for Fermented Substance – for products containing fermented substance(s) (e.g. Cordyceps, Red Yeast Rice)

Processing timeline and fees

The listing  process takes about 60 working days and there are no fees associated with listing.

Key pointers before registration

  1. Ensure that the CPM does not contain any substances from the Poison Act and its schedule.
  2. If the CPM contains substances listed under the Endangered Species (Import & Export) Act, dealers should contact the Wildlife Management Group of the NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.
  3. The labels cannot reference to certain diseases or conditions such as : blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy , hypertension, insanity, kidney disease, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency , frigidity, conception, and pregnancy.
  4. Test report:
  • The date of analysis stated on the test report must be within 2 years from the date of evaluation on the CPM product listing.
  • The product’s batch number must be stated on the test report, and it must be in accordance with the batch numbering system declared in the online application form.
  • If the test result is “not detected/ND”, the limit of detection must be stated on the test report
  • The test result cannot be stated as “less than legal limit”
  1. Quality parameters for CPM should include
  • Storage condition
  • Physical characteristics of the product such as colour, taste, smell, shape, size of capsule, and can be included in the product’s Certificate of Analysis (COA) or as a separate document.
  • Physical specifications as per dosage form
  1. Note that physical samples of the product and testing might be required by the authority upon request. Testing should be conducted based on laboratories with accredited methods.

Useful Reference:

Guidelines on CPM Product Listing  English version and Chinese version

Feel free to share this with your peers who has plans to import Traditional Chinese medicine in Singapore or contact us if you need local expertise to support your listing process.

 

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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