The Development History of China's Cellular Medicine Supervision: From Exploration to the Legal Evolution of Scientific Norms

As a cutting-edge field leading future medicine, the development of cell therapy has always been closely intertwined with the improvement of the regulatory system. Since its inception in the 1990s, the Chinese cell medicine industry has gone through four stages: the exploration period, the regulatory vacuum period, the chaos rectification period, and the scientific regulation period. The regulatory policies have evolved from a lack of rules to the prioritization of systems, gradually constructing a full-chain legal framework that takes into account safety, innovation, and ethics, providing solid support for the healthy development of the industry and the protection of public health rights and interests.

I. Exploration Period (1993 - 2005): Initial exploration of policies and establishment of a basic framework

In the 1990s, cell therapy was still an emerging field globally. China's regulatory authorities "keenly realized the dual needs of technological innovation and standardized management and took the lead in taking the first step towards legalization." In 1993, the former Ministry of Health issued the "Quality Control Points for Clinical Research on Human Somatic Cell Therapy and Gene Therapy", incorporating cell and gene therapy into the regulatory "scope of the Drug Administration Law" for the first time, clarifying that relevant research needed to be applied to the regulatory authorities, marking the initial transformation of cell medicine from laboratory "research to standardized management." In 1999, the former State Drug Administration issued the "Approval Measures for New Biological Products", defining cell therapy as a new biological product and refining the clinical "trial application rules; during the same period, the "Administrative Measures for Genetic Engineering Safety" put forward the principle of safety level control, drawing a safety red line for technological applications. In 2000, the "National Medical Service Price Item Specification" further clarified the charging standards for technologies such as CIK cell therapy, promoting the industry to take a tentative step from "research to application." During this stage, the core of regulation was to follow the technology, and a basic framework was established through fragmented policies. Although a systematic standard was not formed, it laid an institutional foundation for subsequent development.

II. Regulatory Vacuum Period (2005 - 2008): Hidden Worries of Expansion, Exposing the Fragility of the System

After 2005, cell therapy technologies rapidly evolved, but regulation hit a lull due to institutional adjustments and poor " " policy coherence. In 2007, the former State Food and Drug Administration issued the " " " " Administrative Measures for Drug Registration, requiring cell therapies to be declared as new drugs. However, due to an audit storm, the approval of biological products was suspended, leading to a standstill in the approval of numerous projects. At the local level, some medical institutions took advantage of regulatory " " gaps, packaging unvalidated technologies as innovative therapies, and even venturing into clinical applications beyond safety boundaries, indicating signs of disorderly industry expansion. The regulatory vacuum during this period was essentially the result of an imbalance between the speed of technological development and regulatory response capabilities, exposing the vulnerability of the regulatory system " " in aspects such as institutional coordination and policy continuity, and laying the groundwork for subsequent stringent regulation.

III. Chaos Rectification Period (2009 - 2018): Events Forced Reforms, Promoting the Reconstruction of Regulations

In 2009, the former Ministry of Health issued the "Administrative Measures for the Clinical Application of Medical Technologies", which included stem cell and immune cell therapies in the third category of medical technologies (high - risk), forming a dual - track regulatory framework where the National Health Commission manages technologies and the National Medical Products Administration manages drugs. However, due to the blurred definition of technologies and drugs, this system instead became a loophole for some institutions to evade strict approval. More than 3,000 medical institutions flocked to file for record, and projects that had not passed clinical trials were illegally included in medical insurance reimbursement, and the chaos in the industry became increasingly severe. In 2016, the outbreak of the Wei Zexi incident brought the safety hazards and ethical violations of immune cell therapy to public attention, directly prompting the regulatory authorities to urgently suspend all unapproved clinical applications and re - emphasize that cell therapy must be declared in accordance with the drug research and development process. Since then, through rectification, the regulatory authorities have completed the standardized filing of more than 110 medical institutions and 27 clinical projects, and the industry has gradually moved from chaos to order. The regulatory reconstruction in this stage profoundly reflects the legal logic of reform forced by events: only by blocking system loopholes through strict regulations can we curb the abuse of technology and protect the rights and interests of patients.

IV. Scientific Supervision Period (2019 to present): Precise Control, Balancing Safety and Innovation

In 2019, after that, regulation entered a stage of scientific refinement, with the core goal of achieving a dynamic balance between the safety bottom line and the "green light" for innovation. In 2020, the "Measures for the Administration of Drug Registration" introduced the accelerated marketing approval system for the first time. Globally leading therapies such as CAR - T cell therapies like Yescarta and Breyanzi were rapidly approved. This not only shortened the transformation cycle of innovative technologies but also ensured quality through strict safety and efficacy reviews. In 2024, Beijing included 12 types of major diseases' hematopoietic stem cell transplantation in medical insurance. By leveraging policy levers, the technology was promoted to be more inclusive, achieving the unity of accessibility and standardization. Ethical supervision was strengthened simultaneously: The "Civil Code" clearly states that gene - editing research must not violate ethics. The "Measures for Ethical Review of Biomedical Research Involving Human Subjects" covers medical and health institutions at all levels, and the industry - wide ethical review mechanism has been comprehensively upgraded. At the same time, laws such as the "Biosecurity Law of the People's Republic of China (2024 Amendment)" and the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China (2024 Revision)" further regulate the collection, preservation, and international cooperation of human genetic resources, establishing a coordinated mechanism for biosecurity and industrial development. At this stage, regulation has shifted from passive response to active guidance. Through the design of a full - chain and multi - dimensional system, a dynamic balance between innovation vitality and patient safety has been achieved.

Conclusion: The rule of law provides protection and promotes the stable and long - term development of the industry.

The 30 - year regulatory history of Chinese cell medicine is essentially a history of balancing development and regulation. From having no rules to follow to establishing systems first, from passive rectification to active guidance, every evolution of regulatory policies responds to the needs of technological innovation, the expectations of public health, and the bottom line of social ethics. As a high - risk and high - innovation field, the development of cell medicine cannot do without the guarantee of the rule of law for a moment. Only through a scientific, systematic, and dynamic regulatory system can the risk of technology abuse be prevented, the legitimate rights and interests of patients be protected, and at the same time, a reasonable space for innovation be reserved.

In the meantime, promote the sustainable development of the industry on the safe track. In the future, with the further improvement of supporting systems such as the "Administrative Measures for Clinical Research of Stem Cells (Trial)" and the "Good Quality Management Practice for the Operation of Cell Therapy Drugs", the Chinese cell medicine industry is bound to enter a new stage that is more standardized, innovative, and inclusive under the protection of the rule of law.