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DH proactively promotes arrangement of streamlining approval procedures for HK-registered proprietary Chinese medicines for oral use to be registered on the Mainland to further promote healthcare collaboration in GBA (with photos)
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     In response to the announcement made by the National Medical Products Administration (NMPA) earlier on the arrangement to streamline the approval procedures for Hong Kong-registered proprietary Chinese medicines (pCms) for oral use to be registered on the Mainland, the Department of Health (DH) today (April 28) announced that it will spare no effort to drum up publicity and promotions for the local Chinese medicine (CM) industry to help its personnel understand the information and technical requirements required to be submitted by applicants under the new arrangement to facilitate the early and smooth opening up of the Mainland market to more qualified Hong Kong-registered pCms for oral use, while promoting the development of the CM industry in Hong Kong.

     Representatives of the DH today participated in a launching seminar organised by the Center for Drug Evaluation of the NMPA in Shenzhen for representatives of Hong Kong's Chinese medicine enterprises. At the seminar, representatives of the NMPA shed light on the pharmacological and clinical reporting information as well as the technical requirements for Hong Kong-registered pCms to be registered on the Mainland.

     According to the notice regarding the streamlining of approval procedures for Hong Kong- and Macao-registered pCms for oral use promulgated by the NMPA in mid-January this year, the streamlined approval measures will apply to pCms for oral use held by manufacturing companies in Hong Kong, which have been registered with the Chinese Medicine Council of Hong Kong and in use in Hong Kong for more than 15 years. The manufacturing processes of these pCms must comply with the requirements of Good Manufacturing Practice in respect of pCms. Subsequently, the Center for Drug Evaluation of the NMPA today promulgated the application materials and technical requirements for Hong Kong- and Macao-registered pCms for oral use to be registered on the Mainland under the streamlined approval procedures.

     In order to help the CM industry understand the relevant policies and registration requirements in a timely manner, the Chinese Medicine Regulatory Office (CMRO) of the DH will assist the trade in grasping the details of the new arrangement through various channels, including conducting seminars on a monthly basis to exchange views with the industry on the development of CM in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA), and at the same time responding to enquiries from the industry on the relevant applications and providing appropriate assistance.

     Furthermore, the CMRO has set up a dedicated webpage to provide updates on the development of CM in the GBA.

     "The Hong Kong Special Administrative Region (HKSAR) Government expresses its gratitude to the Central Government and the NMPA for extending the arrangement to streamline the approval procedures for Hong Kong- and Macao- registered proprietary pCms from CM oil for external use to pCms for oral use. The DH has maintained close liaison with the relevant Mainland authorities, actively assisted the Mainland authorities in their research work and participated in discussions on the formulation of relevant policies and the requirements for streamlined registration. This new measure has greatly streamlined the requirements and shortened the time for approval, thereby opening up a more convenient channel for the Hong Kong CM industry to tap into the vast Mainland market, further facilitating Hong Kong pCm manufacturers' market expansion on the Mainland and promoting the development of the CM industry. As outlined in the Chief Executive's 2024 Policy Address, the HKSAR will scale up medical collaboration in the GBA. The new arrangement marks another milestone in this regard. To make greater contributions to the great rejuvenation of the Chinese nation, Hong Kong, China, will continue to capitalise on its strengths in medical and healthcare excellence, the convergence of Chinese and Western cultures, and as a cosmopolitan city, and fully play its role as a bridgehead for Chinese medicine to go global and as a super-connector," the Director of Health, Dr Ronald Lam, said.

     Since the implementation of the streamlined approval procedures for pCms for external use registered in Hong Kong and Macao in 2021, 13 Hong Kong registered pCms have been approved for sale on the Mainland through streamlined procedures. As of today, the total number of registered pCms in Hong Kong is about 8 200; for oral use is about 5 000, of which about 200 have been on the market for 15 years and more, with the Certificate of Good Manufacturing Practice in respect of pCms.

     The CMRO will continue to actively follow up and promote the Mainland's arrangement of streamlining approval procedures to the industry, and maintain close contact with the CM sector and relevant stakeholders in order to promote the industry development. For more information on the development of CM, please visit the website of the CMRO.
 
Ends/Monday, April 28, 2025
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Following the earlier announcement made by the National Medical Products Administration (NMPA) on the arrangement to streamline the approval procedures for Hong Kong-registered proprietary Chinese medicines for oral use to be registered on the Mainland, representatives of the Department of Health today (April 28) participated in a launching seminar organised by the Center for Drug Evaluation of the NMPA in Shenzhen for representatives of Hong Kong's Chinese medicine enterprises. Photo shows the Deputy Director General of the Department of Drug Registration of NMPA, Mr Wang Hainan, addressing the launching seminar.
Following the earlier announcement made by the National Medical Products Administration (NMPA) on the arrangement to streamline the approval procedures for Hong Kong-registered proprietary Chinese medicines for oral use to be registered on the Mainland, representatives of the Department of Health today (April 28) participated in a launching seminar organised by the Center for Drug Evaluation of the NMPA in Shenzhen for representatives of Hong Kong's Chinese medicine enterprises. The Deputy Director General of the Department of Drug Registration of NMPA, Mr Wang Hainan (front row, fourth right), the Director of the Administrative Licensing Division of the Guangdong Provincial Medical Products Administration, Ms Luo Yubing (front row, third right), are pictured with the Acting Assistant Director of Health (Chinese Medicine), Mr Robert Law (front row, sixth right), the President of the Federation of the Hong Kong Chinese Medicine Practitioners and Chinese Medicines Traders Association, Mr Tommy Li (front row, fifth right), and other representatives of Hong Kong's Chinese medicine enterprises attending the seminar.