The Hong Kong Special Administrative Region Government today welcomed the National Medical Products Administration’s (NMPA) announcement 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 & Development of Pharmaceutical & Medical Device in the Greater Bay Area, the Guangdong Provincial Medical Products Administration promulgated the notice regarding the streamlining of approval procedures for Hong Kong and Macau 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 measure to pCms for oral use.

The NMPA promulgated today the notice regarding the streamlining of approval procedures for Hong Kong and Macau 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.

In addition, the manufacturing processes of these pCms must comply with the requirements of Good Manufacturing Practice for medicines.

Secretary for Health Prof Lo Chung-mau said the Hong Kong SAR 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 Macau in 2021, 13 Hong Kong registered pCms have been approved for sale on the Mainland through streamlined procedures.

The new arrangement announced today symbolises the acceleration of the implementation of the Greater Bay Area Chinese medicine policies, further facilitating Hong Kong pCm manufacturers’ market expansion on the Mainland, and promoting the Chinese medicine industry’s development.

Prof Lo added that the Hong Kong SAR 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 Health Bureau’s Chinese Medicine Development Fund launched the Greater Bay Area Proprietary Chinese Medicine Industry Development Support Scheme in February 2024.

The support scheme provides financial support to Hong Kong pCm manufacturers or wholesalers in respect of the registration application, among others.

In light of the latest policy, the Health Bureau will further expand the scope of the scheme in a timely manner.