Delegates and committee members are focusing on the stem cell industry! In 2021, multiple representatives and committee members at the Two Sessions of China offered valuable suggestions to boost the development of the stem cell sector.
来源:Stem Cell Home
2021-03-04
With the 2021 Two Sessions fast approaching, several deputies and members have offered valuable suggestions for the development of the stem cell industry. This move is expected to accelerate China's stem cell sector, expedite its clinical translation, and ultimately meet patient needs while enhancing the health and well-being of the public.
The entire stem cell industry is on the cusp of an explosive growth phase, with technology iterating at an accelerating pace—now is the time for our country to firmly seize this golden opportunity.

Accelerate the progress of translating stem cell technology into viable pharmaceutical products.
National People's Congress deputy Li Zhenguo stated that increasing support for the bioeconomy and biotechnology, while mobilizing resources from across society, is crucial for jointly advancing the development of the bioeconomy. This effort will play a vital role in safeguarding the lives, biological security, and economic stability of China's people in the future. Notably, the stem-cell industry— an important sector within biotechnology—achieved groundbreaking progress in 2020.
Li Zhenguo recommends accelerating the translation of stem cell technology into viable pharmaceutical products, thereby fostering high-quality, rapid growth in the industry. First, he suggests standardizing the donation of human tissue and cells by urging the nation to promptly introduce China’s version of the "Good Tissue Practice (GTP)" guidelines—clearing critical hurdles for the country to potentially leapfrog ahead in fields like regenerative medicine. Second, he advocates establishing ethical criteria for clinical approval of stem cell-based products. Additionally, he emphasizes strengthening technical guidance on stem cell manufacturing processes and quality systems, while also developing comprehensive guidelines for stem cell quality control. Furthermore, Li calls for the creation of ethical review frameworks that provide clear evaluation criteria—covering aspects such as source materials, production methods, and intended therapeutic applications—to help assess and manage ethical risks effectively during clinical trials and research. Finally, he highlights the need for increased financial support to address funding challenges faced by innovative drug developers before their products reach the market. To this end, he proposes piloting subject-funded clinical studies in select regions across China, paving the way for cost-effective drug development and commercialization.
Meanwhile, Li Zhenguo suggested strengthening policy guidance to effectively integrate traditional medicine with precision medicine.
Promoting the high-quality development of China's stem cell industry
National Committee of the Chinese People's Political Consultative Conference member Chen Haijia has suggested further advancing the high-quality development of China's stem cell industry, strengthening the commercialization of stem cell technologies and their application in clinical research. She also emphasized accelerating China's transition from a global follower and competitor to a leader in the stem cell industry, thereby enhancing the nation's core competitiveness in the international stem cell arena and securing a commanding position in the global stem cell market.
Stem cells are a global focus and hotspot, representing the cutting edge of life sciences and offering new technological approaches to treating severe, intractable diseases. For Healthy China, they also stand as a key strategic priority. In recent years, the nation has placed tremendous emphasis on and provided robust support for stem cell research, leading to significant breakthroughs in areas such as basic science, clinical studies, patent applications, and the publication of scientific papers. However, under the current circumstances, to further advance the clinical translation of stem cell therapies and ultimately improve public health and well-being, we must strengthen efforts in several critical areas.
In the current context, it is crucial to further strengthen the government's guidance for the entire industry and establish corresponding laws and regulations. This approach will better support the industry's healthy and sustainable development—particularly in terms of the government's overarching strategic planning.
In stem cell research, there are currently two main pathways: one focuses on new drug development, while the other is centered on clinical studies. For clinical research, it’s crucial to further expand the number of hospitals registered for stem cell clinical trials, which will help accelerate the translation of scientific discoveries into tangible outcomes. Of course, cost remains an issue—currently, the stem cell industry still faces certain regulatory gaps in society. To address this, hospitals should take the lead in establishing robust stem cell platforms. This initiative is key to enhancing industry-wide oversight and fostering high-quality, sustainable growth. By doing so, hospitals can guide the stem cell sector toward standardized practices, given their inherently structured environments, equipped with cutting-edge medical expertise and advanced technologies. Expanding clinical research institutions and platforms in the stem cell field will also facilitate the integration of the industry into the government’s regulatory framework, ensuring safer and more reliable advancements in this promising area.
Regarding fees, I believe authority should be delegated to provincial-level research platforms. For instance, charges could be applied for services like cell preparation and clinical testing, while cell therapy could remain free. This approach would significantly boost enthusiasm for advancing the translation of clinical research into practical applications.
According to clinical data feedback, patients at the hospital have a highly urgent need for treatments targeting rare diseases. To address these needs—whether it’s curing illnesses or improving overall health—clinical stem cell research emerges as an excellent avenue.
Meanwhile, in terms of cell preparation, we should further accelerate the development of regional cell preparation centers and integrate them into national regulatory frameworks such as the National Medical Products Administration and the National Health Commission. This approach will ensure product safety from the very beginning, fostering a modernized governance system and enhancing governance capabilities across the board—ultimately safeguarding the growth and advancement of the entire industry.
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