Registration of Proprietary Chinese Medicines > Table 1: Documents required for transitional registration of pCms

Part I: To be submitted upon application
Group I
Group II
Group III
1. Completed application form and "Transitional registration checklist (A)"
Required
Required
Required
2. Application fee
Required
Required
Required
3. Personal information of the person-in-charge of the company
Required
Required
Required
4. Documentary proofs of manufacture or sales history of the product
Required
Required
Required
5. Product sample and prototype sales pack
Required
Required
Required
6. Master formula
Required
Required
Required

 

Part II: To be submitted within 1 year from the deadline of application for transitional registration
Group I
Group II
Group III
1. Transitional registration checklist (B)
Required
Required
Required
2. Copy of manufacturing authorization issued by the country of origin (if applicable)
Required
Required
Required
3. Copy of free sale documentation of the product issued by the country of origin (if applicable)
Required
Required
Required
4. Labels and package insert which have complied with the laws
Required
Required
Required
5. Heavy metals and toxic element test report
Required
Required
Required
6. Pesticide residues test report
Required
Required
Required
7. Microbial limit test report
Required
Required
Required
8. Interpretation and principle of formulating a prescription
Required(1)
Required(1)
Required(1)
9. Reference materials on product efficacy
Required
Required
Required
10. Manufacturing method
Required
Required
Required
11. Physicochemical properties of crude drugs
Required
Required
Required

 

Part III: To be submitted within 5 years from the deadline of application for transitional registration
Group I
Group II
Group III
1. Transitional registration checklist (C)
Required
Required
Required
2. Acute toxicity test report
Not required
Required
Required
3. Long-term toxicity test report
Not required
Required
Required
4. Local toxicity test report
Not required
Required(2)
Required(2)
5. Mutagenicity test report
Not required
Required(3)
Required(4)
6. Carcinogenicity test report
Not required
Required(5)
Required(6)
7. Reproductive and development toxicity test report
Not required
Required(7)
Required(8)
8. Summary report on product safety documents
Required
Required
Required
9. Principal pharmacodynamic studies report
Not required
Required
Required
10. General pharmacological studies report
Not required
Required
Required(9)
11. Clinical trial protocol and summary report
Not required
Required
Required
12. Summary report on product efficacy documents
Required
Required
Required
13. Product specification, method and certificate of analysis
Required
Required
Required
14. Accelerated stability test report or general stability test report
Required(10)
Required(10)
Required(10)
15. Real-time stability test report
Not required
Required
Required

 

Notes:

  1. If the product is a single Chinese medicine granules, submission of this document may be exempted.
  2. This document is only required for those pCms to be applied on skin or mucous membranes.
  3. This document is only required for those pCms which contain ingredient(s) with cytotoxic or known carcinogenic/mutagenic effects.
  4. This document is only required for those pCms which contain newly discovered Chinese herb(s), ingredient(s) with cytotoxic or known carcinogenic/mutagenic effects.
  5. This document is only required for those pCms which contain ingredient(s) with known carcinogenic/mutagenic effects or have been found positive in mutagenicity test.
  6. This document is only required for those pCms which contain newly discovered Chinese herb(s) or ingredient(s) with known carcinogenic/mutagenic effects, or have been found positive in mutagenicity test.
  7. This document is only required for those pCms which relate to pregnancy, have proven to have toxic effect on reproductive system in other toxicity tests, or have been found positive in mutagenicity test.
  8. This document is only required for those pCms which contain newly discovered Chinese herb(s), relate to pregnancy, have proven to have toxic effect on the reproductive system in other toxicity tests or have been found positive in mutagenicity test.
  9. For pCms under the new medicines category with altered routes of administration, altered dose form or new additional indication(s), submission of this document may be exempted.
  10. If a real-time stability test report is to be submitted, there is no need to submit accelerated stability test report or general stability test report.