As a facilitation measure for Hong Kong residents working and living in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) to seek healthcare services, National Medical Products Administration announced the Work Plan for Regulatory Innovation and Development of Pharmaceutical and Medical Device in the Guangdong-Hong Kong-Macao Greater Bay Area (Work Plan) in November 2020. It allows designated healthcare institutions operating in the GBA to use Hong Kong-registered drugs with urgent clinical use, and medical devices used in Hong Kong public hospitals with urgent clinical use, subject to the approval of Guangdong Province (the Measure).
The Hong Kong Special Administrative Region (HKSAR) Government has been maintaining close liaison and discussion with the Guangdong Provincial Medical Products Administration (GDMPA) to implement the Measure at the University of Hong Kong-Shenzhen Hospital (HKU-SZH) on a trial basis. GDMPA commenced the Measure at the HKU-SZH on a trial basis in Jan 2021, which has been completed on 31 July 2021.
On 27 August 2021, GDMPA and the Health Commission of Guangdong Province announced "Guangdong Province - Guangdong-Hong Kong-Macao Greater Bay Area Interim Regulations on the Administration of Imported Pharmaceuticals and Medical Devices for Urgent Clinical Needs in China" and the relevant policy documents to extend the implementation of the Measure in the nine cities in the GBA The Measure is gradually extended from Shenzhen to cover other designated healthcare institutions in the GBA. The first batch of 5 designated hospitals included the HKU-SZH, Modern Hospital Guangzhou, Guangzhou United Family Hospital, C-MER (Zhuhai) Dennis Lam Eye Hospital and Zhongshan Chenxinghai Hospital. The second batch of 14 designated hospitals included The First Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial People's Hospital, Shenzhen Qianhai Shekou Free Trade Zone Hospital, Hengqin Branch of Zhuhai People’s Hospital, Dongguan Songshan Lake Tungwah Hospital, etc. (Details - Chinese only).
Up to April 2023, 23 drugs and 13 medical devices are allowed to be used in the designed healthcare institutions through the Measure.
The HKSAR Government will continue to closely collaborate and communicate with the GDMPA on the Measure with a view to expanding the directory of drugs and medical devices as soon as possible, and extending the arrangement gradually to cover more designated healthcare institutions in the GBA.
GDMPA now accepts and reviews applications for the Measure, please click the button below for details (Chinese only).
Application for the Measure (Drug)
Application for the Measure (Medical Device)
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