Source: Stem Cells and Genetic Sciences

In recent years, as a frontier medical field, stem cell technology has attracted wide attention for its great potential in regenerative medicine and treatment of chronic diseases. However, the safety, effectiveness and ethical issues of this technology have also aroused widespread discussion in society. In this context, we must recognize that state regulation of stem cells is not only the guidance of science, but also the guarantee of public health. Today, we will take a detailed look at the regulatory model of stem cells in China.

Background and significance of stem cell regulation

The rapid development of stem cell technology gives us the opportunity to treat some diseases that traditional medicine has failed to solve, but it also brings many challenges. For example, how to ensure the safety and effectiveness of stem cell therapy? How to avoid ethical problems? These are all questions we must consider when promoting the use of stem cells. Therefore, the regulation of the state is not only necessary, but also reflects the responsibility of the patients and the public.

The regulatory model of stem cells in China

China's stem cell supervision model can be summarized as "double supervision". This model not only incorporates stem cell products into pharmaceutical management, but also regulates stem cell clinical research as a medical technology.

1. Stem cell products are regulated as pharmaceuticals

Since 2017, the China Center for Drug Evaluation (CDE) has gradually begun accepting applications for clinical trials of stem cell drugs. This means that all stem cell products must go through a registration process similar to that of new drugs, including exploratory and confirmatory trials, before they can be submitted for marketing. At the same time, the country has also issued a series of technical guidelines, such as the Technical Guidelines for Pharmaceutical Research and Evaluation of human stem Cell Products (Trial), to ensure that the development and production processes of these products are in line with norms.

2. Archival management of stem cell clinical research

In terms of clinical research, stem cell research institutions and projects need to be documented. This is to encourage standardized clinical research, while also ensuring the safety and science of research. However, this also brings some challenges, such as the high requirements of medical institutions in terms of quality control, risk management and stem cell knowledge.

Standard building and international cooperation

In terms of standard construction, China has not only developed a series of domestic standards, such as "Stem cell general Requirements" and "Biobab pluripotent stem cell management technical specifications" (GB/T 42466-2023), but also actively participated in the development of international standards, such as "human and mouse pluripotent stem cell general requirements" (ISO 24603). The formulation of these standards not only plays a guiding role in domestic stem cell research and application, but also promotes China's international exchange and cooperation in the field of stem cells. With the continuous improvement of China's stem cell regulatory policy and the accumulation of practical experience, the application of stem cell technology in China has a broad prospect. The country's strict supervision will ensure that the technology serves more patients under the premise of safety and effectiveness, while also providing strong support for the healthy development of China's biomedical industry.