Ministry of Commerce, National Health Commission, and National Medical Products Administration: Notice on Piloting the Expansion of Openness in the Medical Sector

Shangzi Han [2024] No. 568

The competent departments of commerce, health, human genetic resources, and drug supervision and administration in Beijing, Tianjin, Shanghai, Jiangsu, Fujian, Guangdong, and Hainan:

In order to implement the decision-making and deployment of the Third Plenary Session of the 20th CPC Central Committee on expanding independent opening-up, introduce foreign investment to promote high-quality development of my country's medical-related fields, and better meet the medical and health needs of the people, it is planned to carry out pilot work on expanding opening-up in the medical field. The relevant matters are hereby notified as follows:

I. Biotechnology

From the date of issuance of this notice, foreign-invested enterprises are allowed to engage in human stem cell, gene diagnosis and treatment technology development and technology application in China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone, and Hainan Free Trade Port for product registration, listing, and production. All products that have been registered, marketed, and approved for production can be used nationwide. Foreign-invested enterprises that intend to conduct pilot projects should abide by the relevant laws, administrative regulations, and other provisions of my country, comply with the requirements of human genetic resource management, drug clinical trials (including international multi-center clinical trials), drug registration, drug production, ethical review, and perform relevant management procedures.

2. Wholly Foreign-Owned Hospitals

It is proposed to allow the establishment of wholly foreign-owned hospitals (except for traditional Chinese medicine hospitals, excluding mergers and acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and the entire island of Hainan. The specific conditions, requirements and procedures for the establishment of wholly foreign-owned hospitals will be notified separately.

The competent departments of commerce, health, human genetic resources and drug supervision and administration in the pilot areas should, in accordance with the division of responsibilities, increase policy publicity, actively connect with willing foreign-invested enterprises and strengthen services; at the same time, they should strengthen inter-departmental consultations, and supervise and manage pilot enterprises in accordance with the law within their respective responsibilities, timely identify and effectively prevent risks, and solidly promote the pilot work of expanding opening up in the fields of biotechnology and wholly foreign-owned hospitals to ensure that the pilot work achieves practical results.

For any problems encountered during the pilot process, please contact the Ministry of Commerce, the National Health Commission and the National Medical Products Administration in a timely manner.

Ministry of Commerce

National Health Commission

National Medical Products Administration

September 7, 2024