China
Unlocking Potential: China Welcomes Foreign Investment in Cell Therapy and Fully Foreign-Owned Hospitals in Select Pilot Cities
On September 8, 2024, MOFCOM expanded pilot programs in China’s medical sector, allowing foreign-invested enterprises to engage in cell and gene therapy in select free trade zones and permitting wholly foreign-owned hospitals, while adhering to regulations and restrictions.
On September 8, 2024, the Ministry of Commerce (MOFCOM) published a circular on its official website announcing the expansion of pilot programs for opening up the medical sector (the Circular). This circular lifts bans on foreign-invested enterprises (FIEs) engaging in cell and gene therapy (CGT) in selected free trade zones (FTZs) and permits wholly foreign-owned hospitals in selected cities.
This follows the release of the full text of the “Special Administrative Measures for Foreign Investment Access (Negative List) (2024 Edition)” (2024 FI Negative List) by the MOFCOM and the National Development and Reform Commission (NDRC) on the same day.
While the final 2024 FI Negative List still includes provisions prohibiting investment in human stem cells, gene diagnosis and treatment technology development and application, and limiting medical institutions to joint ventures, the relaxation of foreign investment limits in CGT and medical institutions in pilot cities aligns with the directives from the State Council meeting, offering new opportunities for foreign investors eyeing China’s biotech and healthcare sectors.
Below, we summarize the key points of the Circular and delve into its implications.
According to the Circular, effective immediately, FIEs are now permitted to engage in the development and application of human stem cell, gene diagnosis, and treatment technologies within the China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone, and Hainan Free Trade Port (FTP). These activities are aimed at product registration, listing, and production. Once registered, listed, and approved for production, these products can be utilized nationwide.
Despite this relaxation, FIEs participating in the pilot program must adhere to relevant Chinese laws and regulations, including those related to human genetic resource management, drug clinical trials (including international multi-center clinical trials), drug registration and listing, drug production, and ethical review, and must follow the necessary management procedures.
| This article was first published by China Briefing , which is produced by Dezan Shira & Associates. The firm assists foreign investors throughout Asia from offices across the world, including in in China, Hong Kong, Vietnam, Singapore, and India . Readers may write to info@dezshira.com for more support. |
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