In August 2024, the Beijing City Semi-annual Working Conference on Drug Regulation was held, and it was particularly affirmed that the work of issuing the country's first stem cell "Drug Production License" was carried out.

The meeting believed that in the first half of 2024, the Beijing City Food and Drug Administration will thoroughly implement the decisions and arrangements of the municipal party committee and municipal government, unify deepening reform, strengthening supervision and promoting development, continue to build a solid bottom line for drug safety, accelerate the R & D and marketing of innovative drugs and devices, and continuously improve service development capabilities. All work is progressing smoothly and effectively. Strengthen the supervision of "two products and one device", and the pass rate of drug supervision and sampling continues to remain above 99%; the cumulative number of approved third category innovative medical devices and artificial intelligence medical devices ranks first in the country; it is the first in the country to carry out the review and approval of drug supplementary applications. Reform of procedures, 11 clinical trial institutions have become the first batch of pilots; closely cooperate with the Municipal Health Commission to vigorously promote the establishment of a green channel for the approval of imported drugs and devices urgently needed in clinical needs; Together with the Municipal Health Commission and the Municipal Medical Insurance Bureau, we will promote the establishment of a pioneer zone for drug protection for rare diseases in the Tianzhu Comprehensive Bonded Zone to promote the transformation from "people waiting for drugs" to "drugs waiting for others"; with the help of the collaborative advantages of the "three medical services", we will accelerate the promotion of "drugs" The construction of the whole life cycle management system will realize the transformation from "pure on-site inspection" to the combination of "on-site + off-site" in six fields; the country's first stem cell "Drug Production License" will be issued; Optimize the implementation of the filing of multi-color and multi-flavor imported cosmetics, complete the filing of 6 imported products, effectively shortening the filing time by 3 weeks; lead 7 provinces and cities to complete the research on "Administrative Penalty Discretion Rules and Exemption List in the Pharmaceutical Field"; Successfully held the Beijing-Tianjin-Hebei Regional Cooperation Joint Conference on Drug Supervision to accelerate the cultivation and development of new quality productivity in the regional pharmaceutical industry.

The first license: a reflection of multiple meanings

1. Reflecting equal emphasis on innovation and standardization

On the road to stem cell drug research and development, innovation and regulation are like the wings of a bird and the two wheels of a car. The issuance of China's first stem cell "Pharmaceutical Production License" reflects the equal emphasis on innovation and regulation.

First of all, from an innovative perspective, breakthroughs in stem cell technology have provided new treatment options for a variety of refractory diseases. Behind these innovative achievements is the hard work and unremitting exploration of countless scientific researchers. The issuance of the "Drug Production License" provides a solid guarantee for these innovations to move from the laboratory to the market. It has encouraged more researchers to devote themselves to stem cell drug research and development and promoted the continuous progress of the entire industry.

Secondly, from a normative perspective, the research and development and production of stem cell drugs need to strictly abide by relevant laws, regulations and quality standards.

The issuance of China's first stem cell "Drug Production License" is based on a deep understanding and high regard for this point. It requires companies to reach international advanced levels in all aspects such as research and development, production, and quality control to ensure the safety and effectiveness of drugs. This standardized and standardized production model is not only conducive to enhancing the international competitiveness of my country's stem cell drugs, but also provides a strong guarantee for the safety of patients 'medication.

2. Opportunities to promote high-quality industrial development

The issuance of China's first stem cell "Pharmaceutical Production License" is not only recognition of a single enterprise, but also a powerful promotion of the high-quality development of the entire stem cell industry.

On the one hand, the issuance of this certificate will stimulate the enthusiasm and confidence of more companies to devote themselves to the research and development of stem cell drugs. With the continuous improvement of policies and growing market demand, more and more companies will increase investment in the stem cell field and promote technological innovation and industrial upgrading. This will form a virtuous cycle and promote the rapid development of the entire industry.

On the other hand, the commercial production of stem cell drugs will drive the improvement and development of relevant industrial chains. From upstream raw material supply to midstream manufacturing to downstream sales services, the entire industrial chain will gradually mature and improve. This will provide a new source of power for the high-quality development of my country's biomedical industry.

3. Global opportunities and challenges

This is an important milestone in the development of China's biomedical industry and an important opportunity for my country to face the global biomedical market.

With the continuous deepening of globalization and the rapid development of biomedical technology, international cooperation and exchanges have become increasingly frequent. As the world's second largest economy and populous country, China has huge market potential and development space in the field of biomedicine.

The commercial production of stem cell drugs will provide strong support for Chinese companies to enter the world stage. By strengthening cooperation and exchanges with our international counterparts, we can learn from their advanced experience and technological achievements to enhance our competitiveness; at the same time, we can also promote our innovations to the international market and provide more and better treatment options for patients around the world.

But opportunities and challenges often go hand in hand. In the process of facing the world, we must also be clearly aware of our own shortcomings and gaps. For example, continuous efforts and improvements are still needed in terms of technological innovation, talent training, and international cooperation. Only by continuously strengthening self-construction and improving core competitiveness can we remain invincible in the global biomedical market.