Open AccessDevelopment and investigational new drug application of mesenchymal stem/stromal cells products in China
Author(s) -
Zhao Qinjun,
Han Zhibo,
Wang Jialun,
Han Zhongchao
Publication year - 2021
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.1002/sctm.21-0083
Subject(s) - mesenchymal stem cell , clinical trial , regenerative medicine , drug development , new product development , business , medicine , good manufacturing practice , microbiology and biotechnology , china , product (mathematics) , stem cell , regulatory affairs , pharmacology , marketing , drug , political science , biology , pathology , genetics , law , geometry , mathematics
Mesenchymal stem/stromal cells (MSCs) have broad application prospects for regenerative medicine due to their self‐renewal, high plasticity, ability for differentiation, and immune response and modulation. Interest in turning MSCs into clinical applications has never been higher than at present. Many biotech companies have invested great effort from development of clinical grade MSC product to investigational new drug (IND) enabling studies. Therefore, the growing demand for publication of MSC regulation in China necessitates various discussions in accessible professional journals. The National Medical Products Administration has implemented regulations on the clinical application of MSCs therapy. The regulations for MSCs products as drug have been updated in recent years in China. This review will look over the whole procedure in allogeneic MSC development, including regulations, guidance, processes, quality management, pre‐IND meeting, and IND application for obtaining an approval to start clinical trials in China. The review focused on process and regulatory challenges in the development of MSCs products, with the goal of providing strategies to meet regulatory demands. This article describes a path for scientists, biotech companies, and clinical trial investigators toward the successful development of MSC‐based therapeutic product.