In recent years, the gene therapy medicinal products industry has demonstrated robust growth momentum, providing new therapeutic options for circulatory system diseases, ophthalmic diseases, and other conditions. These products exert their effects by specifically modifying human gene sequences or regulating gene expression. Characterized by complex and diverse active ingredients, marked quality heterogeneity, and rapidly advancing technology, gene therapy medicinal products call for a framework defining product scope and regulatory classification, which constitutes an essential foundation for the scientific regulation of such products. To systematically propose a scope-defining framework and classification operational guidelines for gene therapy medicinal products in China, and to provide reference for both developers and regulatory agencies on product classification, as well as to standardize industry practices in R&D and marketing authorization applications, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) officially issued the Technical Guideline for the Scope and Classification of Gene Therapy Medicinal Products (2026 Edition) (hereinafter referred to as “the Guideline”) in July 2026. This article aims to provide an interpretation of the Guideline by covering the current status of research, development, and regulatory review of gene therapy medicinal products in China, the scope and classification requirements for such products by major international regulatory authorities, the process of drafting and revising the Guideline, its main content, and explanations of key issues. It also analyzes the impact of the Guideline on the technical review system for gene therapy medicinal products and its role in promoting industrial development, for the reference of readers. As various types of gene therapy medicinal products continue to evolve and mature, the relevant technical considerations will be dynamically updated accordingly.

Objective：Cell therapy medicinal products (CTMPs) represent one of the strategic sectors within the biopharmaceutical industry, which is an emerging pillar industry in China. To standardize the scope and classification of CTMPs in China, based on a survey of international regulatory classification frameworks, combined with considerations of the development stage of relevant industry sectors, regulatory practices, and the formulation of technical guidelines in China, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) organized and officially issued the Technical Guideline for Scope and Classification of Cell Therapy Medicinal Products (2026 Edition) (hereinafter referred to as “the Guideline”). This article provided an in-depth analysis and interpretation of the Guideline, with the aim of providing references for the industry and regulatory authorities. Methods：By examining the drafting ideas, revision process, and main content of the Guideline, as well as a comparative analysis of international regulatory classification approaches, this article systematically elucidated the core connotations and extensions of the Guideline. Results：The Guideline established, for the first time, the scope and boundaries of CTMPs under the drug regulatory framework in China. Based on three key elements—material basis and active ingredients, manufacturing processes, and mechanisms of action, a two-tier classification framework for CTMPs was established, and the scientific principles and logic approaches for category determination were clarified. This article further explored the vital significance and impact of the Guideline in facilitating scientific classification guidance, improving the drug regulatory science system, standardizing and guiding research and development and regulatory submission, introducing supportive policies to accelerate review and approval for market access, and promoting alignment with international standards. Conclusion：The Guideline addresses current needs while reserving room for innovation to accommodate new products and emerging business formats. In the future, through a dynamic adjustment mechanism, the scientific classification system will be continuously refined to better suit China’s national conditions, thereby empowering the high-quality development of CTMPs industries.