Chinese Medicine Regulatory Office

Streamlining approval procedures for HK registered traditional pCms for external use to be registered in GBA

To advance the development of Chinese medicine in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA), the National Administration of Traditional Chinese Medicine issued in September 2020 the Construction Plan for the Chinese Medicine Highlands in the Guangdong-Hong Kong-Macao Greater Bay Area (2020-2025). Major Chinese medicines-related measure include streamlining the approval procedures for Hong Kong registered proprietary Chinese medicines (pCms) for external use to be registered in the GBA. Meanwhile, the National Medical Products Administration promulgated in November 2020 the Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area, entrusting the Guangdong Provincial Medical Products Administration (GDMPA) to commence the relevant work in relation to streamlining the registration procedures for importing Hong Kong registered pCms for external use.

The Hong Kong Special Administrative Region Government has been maintaining close liaison with the relevant Mainland authorities to follow up the implementation of the relevant measure. The GDMPA announced the arrangement of streamlining approval procedures for Hong Kong registered traditional pCms for external use to be registered in GBA. Any traditional pCm for external use that has been registered with the Chinese Medicine Council of Hong Kong and in use in Hong Kong for more than 5 years may get registration through the streamlined procedures. Such pCm, upon successful approval, may be sold in the GBA. The GDMPA officially started accepting applications of registration on 9 September 2021. For detail, please visit the website of the People’s Government of Guangdong Province: http://www.gdzwfw.gov.cn/portal/guide/11440000MB2D0344212440172002002

The above measure enables Hong Kong pCm manufacturers to expand their markets, as well as creates favourable conditions for Hong Kong pCm to 'go global' in the long run.