In the first half of 2019, the nation successively introduced a series of policies aimed at regulating and promoting clinical research and translational applications of stem cell therapies, providing crucial support for the rapid advancement of stem cell technology! Local governments and industrial parks have also responded enthusiastically, rolling out supportive measures to bolster the biopharmaceutical industry—particularly in cutting-edge cellular therapies such as immune cell therapy and stem cell treatment. Let us now take a closer look together:

National level

On January 21, 2019, the Ministry of Science and Technology released the "Notice on Issuing the 2019 Project Application Guidelines for Key Special Projects such as 'Stem Cells and Translational Research' under the National Key R&D Program." The notice prioritizes support for 12 research areas, with national funding totaling 400 million yuan, and encourages both stem cell research and their clinical translation applications.

On February 1, 2019, the National Development and Reform Commission issued a public notice soliciting comments on the "Catalogue of Industries for Encouraging Foreign Investment (Draft for Comments)," which encourages foreign investment in the production and development of raw materials related to cell-based therapies. The initiative also aims to attract foreign investors to help accelerate the industrialization and engineering of China's stem-cell sector, ensuring it keeps pace with evolving market demands.

On February 26, 2019, the National Health Commission released the "Administrative Measures for the Clinical Application of Biomedical New Technologies (Draft for Comments)," aimed at standardizing clinical research and translational applications of cutting-edge biomedical technologies, fostering medical advancements, ensuring high-quality healthcare, and safeguarding human dignity, life, and health.

On February 26, 2019, the Chinese Society for Cell Biology released the group standard "Human Embryonic Stem Cells." This standard comprehensively takes into account factors such as scientific research, clinical applications, industry development, and regulatory requirements, systematically outlining the fundamental quality attributes of embryonic stem cells, the technical guidelines for quality control, and the relevant criteria for product use and distribution. It represents a foundational consensus within the stem cell field. Notably, this standard is China’s first-ever product standard specifically tailored for embryonic stem cells.

On March 11, 2019, China's Ministry of Science and Technology released a public notice soliciting comments on the "Regulations on Safety Management for Biotechnology Research and Development (Draft for Comments)," aiming to promote and ensure the healthy, orderly conduct of biotechnology research and development activities in China while safeguarding national biosecurity.

On March 29, 2019, the National Health Commission released the "Administrative Measures for Clinical Research and Translational Applications of Somatic Cell Therapy (Trial)," a draft document intended to standardize and promote clinical research and translational applications of somatic cell therapies. The draft further clarifies that medical institutions, as the primary entities responsible, can conduct clinical research on new technologies such as somatic cell therapy. Once safe and effective data are obtained, these institutions will be able to apply for clinical application approval and even charge fees for such treatments.

The draft also notes that the scientific definition of somatic cells includes stem cells. In 2015, the former National Health and Family Planning Commission, together with the former State Food and Drug Administration, jointly issued the "Administrative Measures for Clinical Research on Stem Cells (Trial)," which has effectively standardized and promoted clinical research in stem cell therapy across China. According to Article 31 of these Measures, "somatic cell therapies subject to specific administrative regulations shall be conducted in accordance with current provisions." Consequently, ongoing work related to clinical research on stem cells continues to follow the guidelines outlined in the "Administrative Measures for Clinical Research on Stem Cells (Trial)."

On June 5, 2019, the Ministry of Science and Technology and the Ministry of Finance issued the "Notice on the Optimization and Adjustment of the National Science and Technology Resource Sharing Service Platform List," approving the establishment of two national-level stem cell banks: the National Stem Cell Resource Bank and the National Stem Cell Translation Resource Bank.

Local level

On February 22, 2019, the Guangdong Provincial People's Government issued the "Notice on the Division of Responsibilities for Several Measures to Support Deepening Reform and Innovation in the Free Trade Pilot Zone," stating that medical institutions within the pilot zone may, based on their technical capabilities and in accordance with relevant regulations, carry out cutting-edge clinical research projects involving stem cell technologies.

On March 22, 2019, the Shanghai Municipal People's Government issued the "Implementation Plan for Carrying Out the 'Several Measures to Support Deepening Reform and Innovation in Pilot Free Trade Zones' in this Municipality," announcing that the Shanghai Free Trade Zone would introduce supportive policies for the stem cell industry. Specifically, a fast-track review mechanism for stem cell products will be established, allowing stem cell products already approved for market launch abroad to proceed with clinical research after undergoing an expedited review process.

On March 27, 2019, the Chongqing Municipal People's Government issued the "Task Division Plan for Implementing the State Council's Measures Supporting Deepening Reform and Innovation in the Free Trade Pilot Zone," under which medical institutions within the pilot zone may, based on their technical capabilities and in accordance with relevant regulations, carry out cutting-edge clinical research projects involving stem cell technologies.

On May 3, 2019, Taiwan's health authority in China approved the first hospital capable of performing autologous immune cell therapy.

On May 10, 2019, the official website of the Chongqing Municipal People's Government officially released the "Notice of the Chongqing Municipal People's Government on Issuing the Special Action Plan for Promoting High-Quality Development of Manufacturing in Chongqing (2019–2022)." The notice explicitly stated that the biopharmaceutical industry would be designated as a key pillar industry for prioritized development.

Focus will be placed on introducing and cultivating biologics and innovative vaccines developed through genetic engineering technologies such as immune antibody technology and protein recombination. We will also actively explore and establish a pipeline for gene-recombined T-cell therapies—including CAR-T (Chimeric Antigen Receptor T-cell Immunotherapy) and TCR-T (T-cell Receptor Therapy with Genetically Modified T Cells)—as well as cell-based bioproducts like mesenchymal stem cells, neural stem cells, and hematopoietic stem cells.

On May 27, 2019, the Zhejiang Provincial Department of Science and Technology released the "Implementation Opinions on Accelerating Innovation and Development in Life and Health Sciences (Draft for Comments)," strengthening policy support. The department also announced the establishment of the Wenzhou Institute of Fudan University, which will focus on cutting-edge areas such as innovative macromolecular drugs, stem cells and immune cells, as well as groundbreaking medical devices, aiming to build a high-end, industry-focused R&D platform.

By 2022, a batch of highly innovative, high-value-added products will be developed in key areas such as small-molecule anti-cancer drugs, antibody therapies, protein-based medicines, next-generation vaccines, cell therapy products, advanced implantable/interventional devices, and cutting-edge medical imaging equipment. This effort will result in more than 20 innovative drugs and over 20 Class III medical devices receiving approval for clinical trials or being launched onto the market. Additionally, regional cell preparation centers and stem cell clinical research facilities—among other R&D and service platforms—will be established to support these advancements.

On June 3, 2019, the Tianjin Municipal Administration for Market Regulation released "Several Opinions on Further Supporting the High-Quality Development of the City's Biopharmaceutical Industry," outlining 10 categories of supportive policies.

Comprehensively integrate and streamline the review, approval, and licensing procedures, requirements, and processes. The approval timeline for drug re-registration will be shortened from 6 months to 15 days, while the review period for drug applications will be reduced from 40 days to 20 days. Additionally, the processing time for drug testing will be cut from 60 days to 30 days. For the pilot program targeting pharmaceutical marketing authorization holders, on-site inspections of drug registration and GMP certification will be conducted jointly, accelerating the overall approval process for market launches.