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National Medical Products Administration's Reply Letter on the "Proposal for Vigorously Promoting Stem Cell Application and Transformation, and Strongly Developing the National Stem Cell Industry Promotion Mechanism"

2022-10-27

Yang Keng, Representative:

We have received your proposal regarding the vigorous promotion of stem cell application and transformation, as well as the robust development of the national stem cell industry and its supporting mechanisms. Here’s our response, aligned with the functions of our bureau:

Cell therapy technology has emerged as a key area of cutting-edge medical development on the international stage in recent years. The National Medical Products Administration places great emphasis on strengthening its review capabilities and conducting technical standardization research for innovative biopharmaceutical products, including stem cells.

1. Clarify the regulatory pathway for cell therapy product registration applications to boost industry confidence in R&D.

In recent years, China has seen rapid advancements in research and development of cell therapy products. To better manage and support the relevant research institutions and companies, the *Drug Registration Management Measures* and its accompanying documents have clearly outlined the regulatory pathway for registering cell therapy products as pharmaceuticals, significantly boosting domestic enterprises' enthusiasm to pursue the development and application of cutting-edge biotechnology products such as cell and gene therapies.

II. Develop and formulate technical guidelines related to stem cell research

In 2017, the former State Food and Drug Administration issued the "Technical Guidance Principles for Research and Evaluation of Cell Therapy Products (Trial)," which clearly outlined the translational pathways and regulatory submission requirements for cell therapy products. Recognizing the growing need for robust regulatory and evaluation frameworks throughout the industrialization of stem-cell–related products, the Center for Drug Evaluation under the National Medical Products Administration subsequently released the "Clinical Trial Technical Guidance Principles for Immune Cell Therapy Products (Trial)" in 2021, followed by the "Non-Clinical Research Technical Guidance Principles for Gene-Modified Cell Therapy Products (Trial)" in 2021, and finally the "Pharmaceutical Research and Evaluation Technical Guidance Principles for Immune Cell Therapy Products (Trial)" in 2022—each step further refining the technical evaluation system.

III. Actively explore post-market regulatory pathways for cell therapy products

Building on preliminary research and studies, the National Medical Products Administration (NMPA) has begun actively exploring post-market regulatory approaches, tools, and measures for cell therapy products—based on the existing pharmaceutical regulatory framework. To promote the scientific, orderly, and healthy development of stem cell research and applications in China, the NMPA has drafted an "Appendix to the Pharmaceutical Production Quality Management Standards" specifically tailored to the unique aspects of cell therapy product manufacturing and quality control. This draft is now open for public consultation.

Next, the National Medical Products Administration will work with relevant national departments to establish an effective regulatory system tailored to their respective responsibilities, continuing to refine related management guidelines and technical standards, thereby fostering a favorable environment for the healthy development of cell therapy in China.

Thank you for your concern and support of pharmaceutical regulatory work.

Contact organization and phone number: National Medical Products Administration, Division of Drug Registration, 010-88331059

Reprint Notice: This article is reprinted from the official website of the National Medical Products Administration. If there is any infringement, please contact us for removal.

The National Medical Products Administration officially released: Guidelines for Quality Management in the Production of Cell Therapy Products (Trial).

The Shanghai Municipal Government has issued a document: Accelerating the R&D and commercialization of cell and gene therapy, as well as related technology products.

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