The medical products administration and health commission of Guangdong province have released a list of clinically urgent drugs and medical devices from Hong Kong and Macau for the Guangdong-Hong Kong-Marco Greater Bay Area (GBA), which includes nine mainland cities: Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing.
Eligibility Criteria for Medical Institutions in GBA Cities
Medical institutions in these cities are eligible to import and use these urgently needed, Hong Kong and Macau-listed drugs and devices if they meet specific conditions, including being established by Hong Kong and Macao medical providers, having the necessary technical capabilities, and adhering to storage and emergency response requirements.
The List of Urgent Clinical Needs
The list comprises 34 drugs and 37 devices that address urgent clinical needs. It includes 23 drugs and 28 devices under the “Hong Kong-Macau Drug and Device Access” policy, which is part of the GBA initiative to provide patients with access to drugs across the region. Additionally, 4 drugs are designated by the National Medical Products Administration (NMPA) as clinically urgent overseas new drugs.
New Entrants on the List
| NO. | Generic Name | Indication | MAH | Specification | Packing Specification |
|---|---|---|---|---|---|
| 1 | Romosozumab | Treatment of severe osteoporosis in postmenopausal women at high risk of fractures. | AMGEN HONG KONG LIMITED | 105mg/1.17ml/shot | 2 shots/box |
| 2 | Follitropin alfa/Lutropin alfa | Treatment of adult female patients with severe deficiency of LH and FSH. | MERCK PHARMACEUTICAL(HK) LIMITED | 450IU/225IU, 0.72mL | 1 pre-filled injection pen/box |
| 3 | Follitropin alfa/Lutropin alfa | Same as above. | MERCK PHARMACEUTICAL(HK) LIMITED | 150 IU/75 IU | 1 bottle of powder and 1 bottle of solvent/box |
| 4 | Eptinezumab | Prevention of migraines in adults experiencing migraine attacks at least 4 days a month. | LUNDBECK HK LIMITED | 100mg/1mL | 1ml/bottle, 1 bottle/box |
| 5 | Etrasimod | Treatment of moderate to severe active ulcerative colitis in patients aged 16 and above. | Everest Medicines (Singapore) Pte. Ltd. | 2mg/tablet | 30 tablets/bottle |
| 6 | Elosulfase alfa | Treatment of patients with type IVA mucopolysaccharidosis (MPS IVA, Morquio A syndrome). | BIOMARIN PHARMACEUTICAL INC. | 5mg/5mL (1mg/1mL) | 1 bottle/box |
| 7 | Tisotumab vedotin | Treatment of recurrent or metastatic cervical cancer in adults. | Seagen Inc. | 40mg | 1 shot/bottle |
