LCQ12: Registration of proprietary Chinese medicines and import and export of Chinese herbal medicines
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Question:
Regarding the registration of proprietary Chinese medicines ("pCms") and the import and export of Chinese herbal medicines, will the Government inform this Council:
(1) of the respective quantities and total values of imported and exported Chinese herbal medicines in each of the past five years;
(2) of the following information on the applications for registration of pCms received by the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong in each of the past five years: (i) the number of applications, (ii) the number of cases in which the Certificate of registration of pCms (the Certificate) was issued, (iii) the number of cases in which the Certificate was not issued, and (iv) among such cases, the main reasons for rejecting the applications for registration;
(3) given that the National Medical Products Administration and the Guangdong Provincial Medical Products Administration respectively promulgated the notice regarding the streamlining of approval procedures for Hong Kong and Macao registered traditional pCms for oral use in January this year and the notice regarding the streamlining of approval procedures for Hong Kong and Macao registered traditional pCms for external use in August 2021, so as to streamline the approval procedures for Hong Kong pCms on the Mainland, whether the Government knows the following information on the applications for registration and selling of pCms on the Mainland submitted by holders of traditional pCms for oral and external use in Hong Kong through the above measures since August 2021: (i) the number of applications, (ii) the number of approved applications, and (iii) the number of types of pCms involved in the approved applications;
(4) whether it knows the registration and selling status of Hong Kong pCms in overseas countries; and
(5) of the measures put in place by the authorities to assist Hong Kong Chinese medicine traders in making full use of the advantages of Hong Kong's trade, testing and certification, and registration systems, etc to actively expand their business on the Mainland and overseas, so as to promote the development of the Chinese medicine industry, thereby developing Hong Kong into a bridgehead for promoting the internationalisation of Chinese medicine?
Reply:
President,
In consultation with the Census and Statistics Department and the Department of Health, the consolidated reply is provided by the Health Bureau as follows:
According to the statistics from the Census and Statistics Department, the quantity and value of imports and total exports of Chinese herbal medicines (Chms) (Note 1) of Hong Kong during the period of 2020 to 2024 are tabulated as follows:
| Year | Imports | Total exports | ||
| Quantity (kg) |
Value ($ million) |
Quantity (kg) |
Value ($ million) |
|
| 2020 | 16 815 982 | 2,930.6 | 3 681 447 | 733.8 |
| 2021 | 17 849 891 | 2,745.6 | 3 619 227 | 709.0 |
| 2022 | 12 878 024 | 2,193.1 | 3 531 117 | 785.4 |
| 2023 | 12 677 674 | 3,287.2 | 6 646 149 | 704.4 |
| 2024 | 12 182 088 | 3,489.8 | 2 959 551 | 692.8 |
The figures indicate that the value and quantity of imports and total exports of Chms of Hong Kong have exhibited a downward trend over the past five years, with a cumulative drop of nearly 28 per cent and 20 per cent in volume of imports and total exports respectively. The Chinese medicines (CMs) industry relayed that such downward trend is mainly attributable to changes in global procurement practice of Chms, as purchasers prefer sourcing Chms directly from places of origin to ensure stable supply and reduce cost, thus affecting the volume of intermediary trade in Hong Kong. In addition, rising costs of Chms may have led to reduced local demand, thereby impacting the overall transaction quantity in the Chms market.
Regarding registration of proprietary Chinese medicines (pCm), under the Chinese Medicine Ordinance (Cap. 549), all pCm must be registered with the Chinese Medicines Board (CMB) under the Chinese Medicine Council of Hong Kong (CMCHK) before they can be sold, imported or possessed in Hong Kong. For a pCm to be registered, it must fulfill the stringent safety, quality and efficacy requirements set out by CMB. According to records, during the period of 2020 to 2024, annual figures received by the CMB under the CMCHK related to pCm registration applications, and the number of cases granted or not granted for a "Certificate of Registration of a pCm" (HKC) are tabulated below:
| Number of cases (Year) | Total | |||||
| 2020 | 2021 | 2022 | 2023 | 2024 | ||
| New applications for a HKC | 24 | 95 | 137 | 266 | 96 | 618 |
| Cases granted for a HKC (Note 2) (Note 3) | 390 | 800 | 810 | 835 | 888 | 3 723 |
| Cases not granted for a HKC (Note 2) (Note 3) | 174 | 234 | 149 | 131 | 75 | 763 |
The main reasons for refusal of registration applications and the number of associated cases are tabulated below:
| Number of cases (Year) | Total | |||||
| 2020 | 2021 | 2022 | 2023 | 2024 | ||
| Failure to submit the required documents, information, samples, and/or other materials specified by the CMB for the evaluation of the pCm registration application; and/or failure to meet the safety, quality, and efficacy requirements for pCm registration as stipulated by CMB | 103 | 103 | 75 | 57 | 19 | 357 |
| Withdrawal of application by the applicant | 64 | 98 | 45 | 44 | 23 | 274 |
| Non-renewal renounce by the HKC holder, or renewal application not approved by CMB | 7 | 33 | 29 | 30 | 33 | 132 |
According to the official website of the National Medical Products Administration, as of June 30, 2025, a total of 16 Hong Kong-registered traditional pCms for external use have been approved for marketing in the Mainland through the streamlined approval procedure. Currently, no Hong Kong- and Macao- registered traditional pCms for oral use has been registered in the Mainland through the streamlined approval procedure. Regarding registration and marketing data for Hong Kong-registered pCms in overseas countries, the Department of Health does not maintain relevant records.
The Government has all along been promoting the internationalisation of Chinese medicine (CM) and developing Hong Kong into a bridgehead for the internationalisation of CM through various initiatives. The permanent premises of the Government Chinese Medicines Testing Institute (GCMTI) is expected to be commissioned in phases starting from the end of this year. The GCMTI will continue to promote the standardisation and internationalisation of CMs and strengthen the quality control of CMs industry on its products through technology transfer. By leveraging Hong Kong's strong reputation in the Mainland and overseas, and by establishing the brand image and standards of CMs in Hong Kong, the GCMTI promotes internationalisation of CM.
Regarding regulation, with the conclusion of the transitional registration system for pCm on June 30, 2025, all pCms sold in Hong Kong must hold valid formal registration (i.e. HKC). This milestone marks a new era in the regulatory regime of CM in Hong Kong, signifying that all pCms sold in Hong Kong have strictly complied with the three core registration requirements, namely safety, quality and efficacy, and fully satisfied the requirements of the Chinese Medicine Ordinance in respect of packaging and labelling. The full implementation of the pCm registration system not solely enhances the protection of public health, but also significantly strengthens international confidence in regulatory regime for CMs in Hong Kong. This would facilitate local registered pCms to go global, and consolidate the strategic position of Hong Kong as an essential hub for the internationalisation of CM.
In addition, the Government also encourages CMs traders to make good use of the Chinese Medicine Development Fund (CMDF) and other trade supporting measures. To align with the national policy on streamlining the approval procedures for Hong Kong- and Macao- registered traditional pCms for external use, the CMDF launched the Guangdong-Hong Kong-Macao Greater Bay Area pCm Industry Development Support Scheme (A5 Scheme) in February 2024 to assist Hong Kong pCm manufacturers or wholesalers to explore the Mainland market. To date, a total of 12 applications have been approved. The Health Bureau will further expand the scope of the A5 Scheme in a timely manner in light of the latest policy directives of extending the scope of the streamlined approval procedures to pCms for oral use. In parallel, various platforms also provide resources and support to the industry to strengthen brand promotion and business development, including the Dedicated Fund on Branding, Upgrading and Domestic Sales (BUD Fund), the SME Export Marketing Fund, and participation in the International Conference of the Modernization of Chinese Medicine and Health Products, which is jointly organised by the Hong Kong Trade Development Council and the industry, with a view to expanding their markets outside Hong Kong, strengthening international exchanges, and exploring co-operative trade opportunities.
The Government will continue to fully leverage the role of Hong Kong as a gateway connecting the world, and further strengthen the role of Hong Kong as a bridgehead for internationalisation of CM, thereby promoting the high-quality and high-standard development of CM in Hong Kong on all fronts.
Note 1: Chms refers to dried or processed forms of herbal medicine specified in Schedule 1 or Schedule 2 of the Chinese Medicine Ordinance.
Note 2: Including new applications for a HKC, conversion cases from a "Notice of confirmation of transitional registration of pCm" to a HKC, and renewal cases for a HKC.
Note 3: The actual processing time for a pCm registration application is subject to the completeness of documentation submitted by the applicant, the complexity of different application categories, and the current caseload of the CMCHK Secretariat. Depending on the submission time and circumstances of each application, the processing of an application may extend beyond the calendar year of initial submission.
Ends/Wednesday, July 16, 2025
Issued at HKT 15:30
Issued at HKT 15:30
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