Importing drugs and medical devices to the GBA via Hong Kong and Macao attracted foreign manufacturers, medtech and pharmaceutical companies to consider since the expedited pathway have been implemented step-by-step in recent years. According to the Interim Provisions on the Administration of Imported Medicines and Medical Devices for Urgent Clinical Use in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) in August 2021, five GBA hospitals have been designated to use drugs and medical devices from Hong Kong upon the approval of the Guangdong MPA:
- HKU-SZH
- Modern Hospital Guangzhou
- Guangzhou United Family Hospital
- C-MER (Zhuhai) Dennis Lam Eye Hospital
- Zhongshan Chenxinghai Hospital
On February 18, 2022, the Guangdong MPA announced a list of the second batch of imported Hong Kong- and Macao-registered drugs and medical devices for urgent clinical use in the Greater Bay Area covering 6 drugs and 1 medical device:
- Alpelisib Film-coated Tablets (drug)
- Erdafitinib tablets (drug)
- Budesonide Prolonged Release Capsules (drug)
- Hydroxocobalamin Powder For Solution For Infusion (drug)
- Brolucizumab (drug)
- Capmatinib (drug)
- CliniMACS Plus System (medical device)
On March 14, 2022, the Guangdong MPA (Medical Products Administration) announced a new version of approval document format will be used by the authorities from March 1, 2022, onwards. A total of 15 drugs and 5 medical devices have been approved so far for import into the GBA including the following drug and medical device approved in March 2022:
- Lorlatinib (drug)
- Brilliant blue G dye for eye surgery (medical device)
Cisema is competent in supporting regulatory affairs for drugs and medical devices in Hong Kong and China. Contact Cisema if you would like to learn more.
