On January 9, 2024, in order to thoroughly implement the deployment of the Central Committee of the Communist Party of China and the State Council on improving the market access system, and in accordance with the work requirements of the "Overall Plan for Deepening Comprehensive Cooperation between Guangdong, Hong Kong, and Macao in Nansha, Guangzhou and the World", the National Development and Reform Commission, Ministry of Commerce, and State Administration for Market Regulation issued the "Opinions on Supporting Nansha to Relax Market Access and Strengthen Regulatory System Reform in Guangzhou" (hereinafter referred to as the "Opinions"). Through innovative reform measures, we will better leverage the leading and driving role of Guangzhou Nansha in the construction of the Guangdong Hong Kong Macao Greater Bay Area, and create a major strategic platform based on the Bay Area, coordinated with Hong Kong and Macao, and oriented towards the world.

In the Opinion, relaxing market access includes multiple aspects such as unmanned sea, land, and air systems, advanced technology application markets, service trade innovation, comprehensive cross-border investment and financing service systems for enterprises, and the pharmaceutical and medical device markets. Especially, in the ninth point of the Opinion: Relaxing Market Access Restrictions for Pharmaceuticals and Medical Devices, the emphasis is on relaxing access to the field of cell therapy in Nansha, Guangzhou.

The content of the Opinion is as follows:

9、 Relax market access restrictions for pharmaceuticals and medical devices

Support the improvement of research and application management standards for various new drugs and medical devices, and allow cell and gene therapy enterprises to rely on medical institutions to carry out clinical applications of restricted cell transplantation therapy technology after being registered with the health department. Allow eligible Hong Kong and Macao enterprises to use domestic human genetic resources to conduct medical research beyond human stem cell and gene diagnosis and treatment. Better leverage the role of the Guangdong Hong Kong Macao Greater Bay Area Evaluation and Inspection Sub center, and explore undertaking related functions. Encourage domestic and foreign biopharmaceutical and health enterprises and research and development institutions to establish factories in Nansha to develop various products. (Responsible departments: National Medical Products Administration, National Health Commission, General Administration of Customs, Guangdong Province and Guangzhou City are responsible according to their respective responsibilities)