Regulatory Evolution and Transformation of China's Cell and Gene Therapy Industry
TL;DR
The Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, which entered into force in 2026, is interpreted, with a particular focus on its new dual-track regulatory framework that comprises a drug registration pathway and a new biomedical technology pathway.
Abstract
Cell and gene therapy (CGT) products have driven a global transformation in medicine, opening new avenues for the diagnosis and treatment of major diseases, while also posing new challenges to regulatory agencies worldwide. In the context of the current global CGT industry landscape, this article systematically reviews the evolution of China's CGT regulatory framework over the past three decades, delves into the stages of regulatory development, and analyzes the profound impact of regulatory policies in different periods on the industry landscape, biopharmaceutical research and development (R&D) activities, and clinical translational application. At present, China ranks among the global leaders in the number of CGT pipelines under development, demonstrating strong momentum for industrial growth. However, under the conventional regulatory paradigm, challenges such as long R&D cycles, inefficient translational application pathways, and unclear delineation of authorities and responsibilities have long constrained the development of the industry. On this basis, this article interprets the Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, which entered into force in 2026, with a particular focus on its new dual-track regulatory framework that comprises a drug registration pathway and a new biomedical technology pathway, and its transformative impact on regulatory approval procedures, clinical translational application, and full lifecycle risk management.