A new program would allow certain drugs currently approved in Hong Kong (“HK”) and Macau, and not currently approved in China, to be used in certain designated healthcare facilities either owned or jointly owned by HK or Macau entities in the Greater Bay Area (“GBA”) of Mainland China (“China”). Since the launch of the program in November, 2020, a very small pilot is being run at the Hong Kong University Shenzhen Hospital ( HKU-SZH ) until July 31, 2021.  The program will be expanded to cover more facilities in nine cities in the Guangdong Province including: Guangzhou, Shenzhen, Zhuhai, Zhongshan, Foshan, Dongguan, Zhaoqing, Jiangmen, Huizhou after July 31, 2021.  The GBA program would provide new access to the China’s growing pharmaceutical market.

According to the “Protocol on GBA Regulatory Innovation for Drug and Medical Device” (available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjzh/20201020145834142.html (in Chinese), hereafter “Protocol” ) published in November 2020, for designated healthcare facilities in GBA, when certain drugs that are approved in HK and not approved in China are urgently needed, China’s Guangdong Province can approve their use.  The main framework related to drugs can be summarized below:

1. The designated healthcare facilities only include a healthcare facility owned or jointly owned with entities in HK or Macau and operated in nine cities in GBA and recognized by the Guangdong Province Health and Wellness Commission (“广东省卫生健康委”).   During the pilot phase until July 31, 2021, the only qualified facility is the HKU-SZH. 
2.  To use the drug, an application needs to be first submitted by the designated healthcare facility, and the Guangdong Province Health and Wellness Commission will evaluate the application.  One key element of such evaluation includes whether the drug is urgently needed.  Based on the evaluation, the designated healthcare facility then needs to submit an application for importation of the drug to Guangdong Province Drug Administration (“广东省药监局”). 
3. A drug import port will be established in the Zhongshan city, Guangdong province for drug importation. 

Also, under the Protocol, the Guangdong Province Drug Administration will establish detailed measures and guidance for drug procurement, importation, storage, transportation and use, as well as how to handle adverse effects, PV, and emergency measures.  The drug’s use and distribution must be traceable.  The Guangdong Province Drug Administration will work with its counter parts in HK and Macau to coordinate and establish a notification mechanism for adverse effects monitoring and reporting.  Also importantly, under the Protocol, the designated healthcare facilities bear the main responsibility for the use of these drugs imported under the GBA program, and they need to ensure the drugs are only used in the facilities.  Also, patients are required to sign consent forms with the healthcare facilities regarding the use of these drugs. 

The first drug that is approved for use in HKU-SZH under the GBA program is the injection of anti-D immunoglobulin.  It was imported for use at HKU-SZH in April 2021.