On August 26, the State Council issued the "Overall Plans for China's (Shandong), (Jiangsu), (Guangxi), (Hebei), (Yunnan), and (Heilongjiang) Pilot Free Trade Zones" (hereinafter referred to as the "Overall Plans").

The "Overall Plan" highlights that establishing free trade pilot zones in six provinces and regions—Shandong, Jiangsu, Guangxi, Hebei, Yunnan, and Heilongjiang—is a major decision made by the Party Central Committee and the State Council, serving as a strategic move to advance reform and opening-up in the new era. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, this initiative will fully implement the spirit of the 19th National Congress of the Communist Party of China and the Second and Third Plenary Sessions of the 19th Central Committee. It will uphold the new development philosophy, pursue high-quality growth, proactively align with and integrate into major national strategies, and better support the overall strategy for opening up to the outside world. Ultimately, these pilot zones are set to become new high grounds for reform and opening-up in the new era.

Among them, Policy provisions related to stem cells and immune cell therapies have been included in the plans for all five newly established free trade pilot zones. , summary as follows:

China (Hebei) Pilot Free Trade Zone

Promote the advancement and innovation of life sciences and biotechnology. Encourage enterprises to conduct research on cutting-edge technologies such as immune cell therapy, monoclonal antibody drugs, gene therapy, and tissue engineering, and allow companies to legally and compliantly engage in new biotherapeutic services. Establish a clinical trial filing system for human genetic resources. Support the construction of a gene data center in the Xiong'an area.

Support the open development of the biopharmaceutical and life sciences industries. Support qualified medical and healthcare institutions within the free trade pilot zone to carry out cutting-edge clinical research projects on stem cells, in accordance with relevant regulations, and establish a streamlined green channel for project registration. Support the clinical application of gene sequencing technology.

Detailed content

China (Hebei) Pilot Free Trade Zone Overall Plan

Promote the advancement and innovation of life sciences and biotechnology. Encourage enterprises to conduct research on cutting-edge technologies such as immune cell therapy, monoclonal antibody drugs, gene therapy, and tissue engineering, and allow companies to legally and compliantly engage in new biotherapeutic services. Establish a clinical trial filing system for human genetic resources. Support the construction of a gene data center in the Xiong'an area.

Support the open development of the biopharmaceutical and life sciences industries. Optimize the quarantine and inspection procedures for special items used in global collaborative R&D within the biopharmaceutical sector. Establish a green channel for importing materials, reagents, and equipment essential for new drug development, exempting companies from obtaining a one-time import clearance certificate for pharmaceuticals while implementing a single approval process with phased verification. Moderately relax regulations on small-batch, low-dose special chemical preparations used in pharmaceutical R&D, and encourage the establishment of stockpiling warehouses within free trade pilot zones. Streamline customs procedures for exporting drug samples and intermediates weighing under 1 kilogram via air transport. Support Shijiazhuang in legally and compliantly developing an import port for pharmaceuticals, with plans to establish a dedicated port for first-imported drugs and biological products once conditions are fully met. Set up a demonstration center and public technical platform for gene testing technologies, fostering clinical applications of gene sequencing techniques and supporting pilot programs for gene mass spectrometry targeting infectious microorganisms and rare diseases. Back eligible medical and healthcare institutions within the free trade pilot zone to initiate cutting-edge clinical research projects involving stem cell technologies, adhering to relevant regulations, and implement an expedited project registration process. Launch a pilot program for the Medical Device Registration Holder system, streamline the approval process for Class II medical devices, and support cross-regional production pilots for medical devices. Additionally, establish a sub-center dedicated to intellectual property rights protection and enforcement assistance in the pharmaceutical sector.