China · National Medical Products Administration · New drugs
Review target
5 working days
regulation
Legal time limit
10 working days
regulation
Steps
5
5 requirements
Application fee
-
Designated hospitals in nine mainland cities of the Greater Bay Area can import urgently needed drugs already marketed in Hong Kong or Macao, and urgently needed advanced devices used by Hong Kong or Macao public hospitals. Products on the catalogue get decisions in about 5 plus 5 working days, others in about 10 plus 10 working days. Hospitals in Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing.
The official review target is 5 working days (regulation). The legal time limit is 10 working days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Hospital designation; 2. Import application; 3. Health authority opinion (5 days); 4. Drug authority permit (5 days); 5. Import and use.
Yes. It relies on approvals from Hong Kong, Macao (reference approval required, reference approval required).
Outcome: Import permit for a designated hospital.
Legal basis: Guangdong Province Regulation on Importing Hong Kong and Macao Drugs and Devices in the Nine Mainland Cities of the Greater Bay Area (in force 2024-12-01)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 10 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. Health authority opinion for catalogue products; another 5 working days for the permit. | 5 working days |
| Legal time limitregulation. Health authority opinion for products not on the catalogue; another 10 working days for the permit. | 10 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in China: Marketing authorization for an innovative drug, Improved new drug (known active substance), Generic chemical drug, Nonprescription (OTC) drug application, Breakthrough therapy procedure, Conditional approval, Priority review and approval, Special approval for public health emergencies, 30 working day review channel for innovative drug clinical trials, Urgent import in the Hainan Boao Lecheng pilot zone, Small-quantity urgent import by hospitals, Expanded access at clinical trial sites, Class I device and IVD filing, Class II device and IVD registration, Class III device and IVD registration. See all routes on the China page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.