China Beijing Establishes Green Channel for Importing Urgently Needed Drugs and Medical Devices
China Beijing has announced a new initiative to streamline the import process for urgently needed drugs and medical devices on September 20, 2024. The Beijing Municipal Medical Products Administration, along with three other departments, has issued a trial implementation plan to create a "green channel" for the temporary import of clinically urgent medications and medical equipment.
Key points of the plan include:
1. Objective: To better serve clinical needs by facilitating the import of urgently required drugs and medical devices not yet approved for marketing in China.
2. Guiding principles:
- Focus on clinical demand and efficiency
- Implement closed-loop management to prevent risks
- Balance supply assurance with quality and safety
3. Main tasks:
- Establish a mechanism to collect and guide clinical demand
- Create a joint evaluation mechanism involving expert groups
- Simplify the evaluation process for subsequent imports of previously approved items
- Enhance customs clearance convenience
- Strengthen supervision during and after the import process
4. Responsibilities:
- Medical institutions will be responsible for the clinical use and management of imported items
- Relevant government departments will provide support and oversight
5. Implementation:
- The plan will be implemented for a trial period of two years
- After the trial period, responsible departments will evaluate the results and consider future steps
This initiative aims to address urgent clinical needs while maintaining safety standards and efficient regulatory processes. It represents a significant step in Beijing's efforts to improve healthcare access and support the development of the medical and health industry.
Similar to existing policies for clinically urgent needs in Hainan and the Greater Bay Area, this initiative serves as one of the channels to accelerate the introduction of innovative foreign products into China. It further demonstrates China's commitment to improving access to cutting-edge medical technologies and treatments across different regions.