The Hong Kong Special Administrative Region (HKSAR) Government today (January 21) welcomed the announcement made by the National Medical Products Administration (NMPA) on the arrangement to streamline the approval procedures for Hong Kong registered traditional proprietary Chinese medicines (pCms) for oral use to be registered on the Mainland.

     To fully implement the Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area, the Guangdong Provincial Medical Products Administration (GDMPA) promulgated the notice regarding the streamlining of approval procedures for Hong Kong and Macao registered traditional pCms for external use on August 27, 2021. Since then, the Health Bureau and the Department of Health have been maintaining close communication with relevant Mainland authorities to explore the feasibility of extending the scope of the aforementioned measure to pCms for oral use. The NMPA promulgated today the notice regarding the streamlining of approval procedures for Hong Kong and Macao registered traditional pCms for oral use. The streamlined approval measure will apply to traditional 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 for medicines.
 
     The Secretary for Health, Professor Lo Chung-mau, said, "The HKSAR Government warmly welcomes the official implementation of the streamlined approval measure, and expresses gratitude to the Central Government and the NMPA for their staunch support for the development of Chinese medicine in Hong Kong all along. Since the implementation of the streamlined approval procedures for traditional 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. The relevant measure has greatly streamlined the requirements and shortened the time for approval, thereby opening up a more convenient channel for the Hong Kong Chinese medicines industry to tap into the vast market on the Mainland. The new arrangement of extending the measure to pCms for oral use announced today symbolises the acceleration of the implementation of the Guangdong-Hong Kong-Macao Greater Bay Area Chinese medicine policies, which are favourable to Hong Kong, further facilitating Hong Kong pCm manufacturers' market expansion on the Mainland and promoting the development of the Chinese medicine industry. The HKSAR Government will actively promote the relevant measure to the Hong Kong pCm sector."

     To assist Hong Kong Chinese medicine traders to make good use of the opportunities brought about by the relevant policy, the Chinese Medicine Development Fund of the Health Bureau launched the Guangdong-Hong Kong-Macao Greater Bay Area Proprietary Chinese Medicine Industry Development Support Scheme in February 2024 to provide financial support to Hong Kong pCm manufacturers or wholesalers in respect of the registration application, supporting them to make applications for registration on the Mainland with the GDMPA for eligible pCms through the streamlined approval procedures. The Health Bureau will further expand the scope of the Support Scheme in light of the latest policy in a timely manner.

Ends/Tuesday, January 21, 2025
Issued at HKT 18:58

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