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National Committee of the Chinese People's Political Consultative Conference member Li Guohua proposed incorporating stem-cell drug research and development into the national strategy, along with formulating a national development plan.

2023-03-10

Addressing the current market乱象 of "inferior products masquerading as high-quality ones" in the stem cell sector, we must strengthen regulatory oversight to safeguard public medication safety. At the same time, we need to reform and streamline the approval process, ensuring that more stem cell products can reach the market promptly and effectively meet the diverse needs of various populations.

"China has achieved several internationally leading breakthroughs in both basic and clinical stem cell research, yet no single stem cell product has been approved for market launch. This clearly highlights the gap between China and developed countries in stem cell drug development and industrialization," said Li Guohua.

He also analyzed the key issues currently facing the field, including the approval system lagging behind the pace of cell-based drug development; the urgent need for advancements and breakthroughs in manufacturing processes; and the lack of a robust public platform for basic research, which is slowing down the translation of research findings into practical applications.

In response to the above issue, Li Guohua suggested incorporating the advancement of stem-cell drug research and development into the national strategy, and developing and implementing a national development plan. The specific recommendations are as follows:

First, we will intensify efforts to reform the approval system. Following international best practices, we should accelerate the development and improvement of an approval system tailored to China's unique context. This includes promptly formulating and issuing guiding technical documents for cell product research and development, while also refining the technical evaluation framework, scientific regulatory systems, and related mechanisms for these products. Additionally, institutions qualified for registration should be encouraged to conduct multi-center clinical studies using products sourced from the same origin. Finally, it is recommended that the review and oversight of clinical study registrations be delegated to provincial-level authorities, bringing regulatory oversight closer to local implementation.

Second, accelerate the enhancement of industrial production capacity. Focus on building a national-level or provincial/ministerial-level public service platform for stem cell production and preparation, providing standardized and safe stem cell products to ensure that users can promptly access reliable, high-quality stem cell options—while also supporting the standardization and scientific rigor of diverse research endeavors. At the same time, accelerate the domestic R&D and localization of large-scale production equipment to prevent reliance on critical technologies held by other countries.

Third, strengthen government oversight. Addressing the current market乱象 of "inferior products masquerading as high-quality ones" in the stem cell sector, we must strengthen regulatory oversight to safeguard public medication safety. At the same time, we need to reform and streamline the approval process, enabling more stem cell products to reach the market promptly and effectively meet the diverse needs of various populations.

Fourth, we will accelerate the development of basic and clinical research centers, as well as a robust translation platform. This includes establishing a nationally recognized stem cell research center focused on foundational studies, along with several other national-level clinical research centers dedicated to stem cell medicine. These initiatives aim to attract top-tier basic and clinical scientists to collaborate on developing stem cell-based products targeting common, challenging, and rare diseases. Additionally, we will create a national-level platform for trading stem cell-related scientific advancements, facilitating the seamless transition of cutting-edge research outcomes into tangible, market-ready products.

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