The Hong Kong Special Administrative Region (HKSAR) Government has warmly welcomed the announcement by the National Medical Products Administration (NMPA) regarding the streamlining of approval procedures for Hong Kong registered traditional proprietary Chinese medicines (pCms) for oral use to be registered on the Mainland. This significant development is part of the broader efforts to implement the Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area.
The new streamlined approval measure, announced today, will apply to traditional pCms for oral use that have been registered with the Chinese Medicine Council of Hong Kong and in use in Hong Kong for more than 15 years. These medicines must also comply with the Good Manufacturing Practice requirements for medicines. This initiative follows the successful implementation of similar streamlined procedures for traditional pCms for external use, which have seen 13 Hong Kong registered pCms approved for sale on the Mainland since 2021.
Secretary for Health, Professor Lo Chung-mau, expressed his gratitude to the Central Government and the NMPA for their support in developing the Chinese medicine industry in Hong Kong. He highlighted that this new arrangement will not only facilitate market expansion for Hong Kong pCm manufacturers on the Mainland but also promote the overall development of the Chinese medicine industry.
To support this initiative, the Chinese Medicine Development Fund of the Health Bureau has launched the Guangdong-Hong Kong-Macao Greater Bay Area Proprietary Chinese Medicine Industry Development Support Scheme, providing financial support to Hong Kong pCm manufacturers or wholesalers for registration applications on the Mainland.
For more information, please visit the Hospital Authority's official website.
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