Registration of Proprietary Chinese Medicines > Table 2: Documents required for registration of pCm

General documents
Group I
Group II
Group III
1. Application form & appropriate checklist
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. Copy of manufacturing authorization issued by the country of origin (if applicable)
Required
Required
Required
6. Copy of free sale documentation of the product issued by the country of origin (if applicable)
Required
Required
Required
7. Product samples and prototype sales pack
Required
Required
Required
8. Label & package insert that have complied with the laws
Required
Required
Required
9. Master formula
Required
Required
Required

 

Product safety documents
Group I
Group II
Group III
1. Heavy metals and toxic elements test report
Required
Required
Required
2. Pesticide residues test report
Required
Required
Required
3. Microbial limit test report
Required
Required
Required
4. Acute toxicity test report
Required
Required
Required
5. Long-term toxicity test report
Required(1)
Required
Required
6. Local toxicity test report
Required(2)
Required(2)
Required(2)
7. Mutagenicity test report
Not required
Required(3)
Required(4)
8. Carcinogenicity test report
Not required
Required(5)
Required(6)
9. Reproductive and development toxicity test report
Not required
Required(7)
Required(8)
10. Summary report on product safety documents
Required
Required
Required

 

Product efficacy documents
Group I
Group II
Group III
1. Interpretation and principle of formulating a prescription
Required(9)
Required(9)
Required(9)
2. Reference materials on product efficacy
Required
Required
Required
3. Principal pharmacodynamic studies report
Not required
Not required
Required
4. General pharmacological studies report
Not required
Not required
Required(10)
5. Clinical trial protocol and summary report
Not required
Not required
Required
6. Summary report on product efficacy documents
Required
Required
Required

 

Product quality documents
Group I
Group II
Group III
1. Manufacturing method
Required
Required
Required
2. Physicochemical properties of crude drugs
Required
Required
Required
3. Product specification, method and certificate of analysis
Required(11)
Required
Required
4. Accelerated stability test report or general stability test report
Required(12), (13), (14)
Not required
Not required
5. Real-time stability test report
Not required(14), (15)
Required(14)
Required(14)

 

Notes:

  1. This document is only required for 'health-preserving medicines' in the non-established medicines category.
  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 the 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 reproductive system in other toxicity tests or have been found positive in mutagenicity test.
  9. If the product is a single Chinese medicine granule, submission of this document may be exempted.
  10. For pCms under the new medicines category with altered routes of administration, altered dose form or new indications, submission of this document may be exempted.
  11. For a pCm that is sold or manufactured in Hong Kong before the commencement of pCm registration system (i.e. before 19 December 2003), the applicant can submit the chemical assay, test method and analytical report that are required in product specification upon the renewal of such registration. For a pCm that is sold or manufactured in Hong Kong after the commencement of pCm registration system (i.e. on/after 19 December 2003), the applicant must submit a complete set of reports upon application.
  12. For a pCm that is sold or manufactured in Hong Kong after the deadline of application for transitional registration, an accelerated stability test report should be submitted and the shelf life of the pCm shall not be longer than 2 years.
    For a pCm that has been sold or manufactured in Hong Kong before the deadline of application for transitional registration, if the sales history is over two years, only a general stability test report is required; if the sales history is less than 2 years, an accelerated stability test report will also be required.
  13. If a real-time stability test report is to be submitted, there is no need to submit accelerated stability test report and general stability test report.
  14. For a pCm that is sold or manufactured in Hong Kong before the commencement of pCm registration system (i.e. before 19 December 2003), the applicant can submit the accelerated stability test report, general stability test report or the real-time stability test report upon the renewal of such registration. For a pCm that is sold or manufactured in Hong Kong after the commencement of pCm registration system (i.e. on/after 19 December 2003), the applicant must submit the stability test report upon application.
  15. For a pCm that is sold, or manufactured, in Hong Kong after the deadline of application for transitional registration, a real-time stability test report should be submitted if the pCm has a shelf life of longer than 2 years.