On September 7, 2024, the Ministry of Commerce co-issued a Notice on Enlarging the Pilot Work in the Medical Field (the Notice) with the National Health Commission (the NHC), and the National Medical Products Administration.
According to the Notice, it permits foreign invested enterprises to engage in the technology development and application of the human stem cell, gene diagnosis, and treatment for the purpose of product registration, listing, and production within the free trade zones in Beijing, Shanghai, and Guangdong, as well as the free trade port of Hainan; and all products that have been registered for marketing and approved for production can be used nationwide. Nevertheless, such proposed foreign invested enterprises shall comply with the relevant Chinese laws and regulations, the requirements of human genetic resources management, drug clinical trials (including the international multi-center clinical trials), drug registration and listing, drug production, ethical review, and other regulations, and perform the relevant management procedures.
It is also worth noting that the Notice also proposes to permit the establishment of hospitals (except for the Chinese medicine and excluding the mergers and acquisitions of public hospitals) wholly owned by foreign enterprises in the cities of Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, and Shenzhen, as well as Hainan province.
In fact, as early as in July 2014, the NHC (previously known as the National Health and Family Planning Commission) and the Ministry of Commerce permitted overseas investors to establish wholly owned hospitals by way of new establishments or mergers and acquisitions in seven municipalities/provinces (Beijing, Tianjin, Shanghai, Jiangsu, etc.). Back then, the establishment requirements included, but not limited to, that the foreign investor applying for the establishment of a wholly foreign-owned hospital shall be a legal person capable of independently assuming civil liability and have experience in directly or indirectly engaging in healthcare investment and management and meet one of the following requirements: a. capable of providing internationally advanced hospital management concepts, management models and service models; b. it can provide medical technology and equipment of international leading level; c. it can supplement or improve local deficiencies in medical service capacity, medical technology, capital and medical facilities. The proposed hospitals to be established shall comply with the basic standards for medical institutions set by the Chinese government.
It is unclear whether there will be major changes to the previous establishment requirements from the ones above, as more specific conditions, requirements, and procedures for such establishments will be announced separately.
Nevertheless, according to a report by the CCTV, such enlargement on the opening pilot work in the medical field is an important opening measure in the field of service trade whereas China just lifted all the foreign entry restrictions in the manufacturing field. In the Negative List (2024 version) regarding the foreign investment entry issued on September 8, 2024, it deletes the two entries of “publication printing to be controlled by Chinese parties” and “prohibition of investment in the application of preparation techniques such as steaming, stir-frying, roasting, calcining, etc., of Chinese medicine tablets and the production of confidential prescription products of proprietary Chinese medicines,” which are the last two restriction entries in the manufacturing field.
According to the Notice, it permits foreign invested enterprises to engage in the technology development and application of the human stem cell, gene diagnosis, and treatment for the purpose of product registration, listing, and production within the free trade zones in Beijing, Shanghai, and Guangdong, as well as the free trade port of Hainan; and all products that have been registered for marketing and approved for production can be used nationwide. Nevertheless, such proposed foreign invested enterprises shall comply with the relevant Chinese laws and regulations, the requirements of human genetic resources management, drug clinical trials (including the international multi-center clinical trials), drug registration and listing, drug production, ethical review, and other regulations, and perform the relevant management procedures.
It is also worth noting that the Notice also proposes to permit the establishment of hospitals (except for the Chinese medicine and excluding the mergers and acquisitions of public hospitals) wholly owned by foreign enterprises in the cities of Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, and Shenzhen, as well as Hainan province.
In fact, as early as in July 2014, the NHC (previously known as the National Health and Family Planning Commission) and the Ministry of Commerce permitted overseas investors to establish wholly owned hospitals by way of new establishments or mergers and acquisitions in seven municipalities/provinces (Beijing, Tianjin, Shanghai, Jiangsu, etc.). Back then, the establishment requirements included, but not limited to, that the foreign investor applying for the establishment of a wholly foreign-owned hospital shall be a legal person capable of independently assuming civil liability and have experience in directly or indirectly engaging in healthcare investment and management and meet one of the following requirements: a. capable of providing internationally advanced hospital management concepts, management models and service models; b. it can provide medical technology and equipment of international leading level; c. it can supplement or improve local deficiencies in medical service capacity, medical technology, capital and medical facilities. The proposed hospitals to be established shall comply with the basic standards for medical institutions set by the Chinese government.
It is unclear whether there will be major changes to the previous establishment requirements from the ones above, as more specific conditions, requirements, and procedures for such establishments will be announced separately.
Nevertheless, according to a report by the CCTV, such enlargement on the opening pilot work in the medical field is an important opening measure in the field of service trade whereas China just lifted all the foreign entry restrictions in the manufacturing field. In the Negative List (2024 version) regarding the foreign investment entry issued on September 8, 2024, it deletes the two entries of “publication printing to be controlled by Chinese parties” and “prohibition of investment in the application of preparation techniques such as steaming, stir-frying, roasting, calcining, etc., of Chinese medicine tablets and the production of confidential prescription products of proprietary Chinese medicines,” which are the last two restriction entries in the manufacturing field.