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-- the ministry of commerce, the national health commission and the national medical products administration issued a notice on launching a pilot program to expand opening up in the medical field.

the following is the original notice:

the competent departments for commerce, health, human genetic resources, and drug supervision and administration in beijing, tianjin, shanghai, jiangsu, fujian, guangdong, and hainan provinces:

in order to implement the decision-making arrangements 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:

1. biotechnology

as of the date of issuance of this notice, foreign-invested enterprises are allowed to engage in the development and application of human stem cells, gene diagnosis and treatment technologies 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, marketing 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 resources management, drug clinical trials (including international multi-center clinical trials), drug registration, drug production, ethical review, etc., and perform relevant management procedures.

2. wholly-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 in the pilot areas should, in accordance with their division of responsibilities, step up policy publicity, proactively 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, promptly identify and effectively prevent risks, and steadily advance the pilot work of expanding opening up in the fields of biotechnology and wholly-owned hospitals to ensure that the pilot work achieves practical results.

if you encounter any problems 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

state food and drug administration

september 7, 2024