Department of Clinical Pharmacy and Pharmaceutical Management, School of Pharmacy, Fudan University, Shanghai, China; Sino-Danish Regulatory Science Center, Fudan University, Shanghai, China.
Department of Clinical Pharmacy and Pharmaceutical Management, School of Pharmacy, Fudan University, Shanghai, China.
Pharmacol Res. 2020 Aug;158:104889. doi: 10.1016/j.phrs.2020.104889. Epub 2020 May 17.
In recent years, remarkable progress has been made in the fundamental research and on clinical development of cell therapy. Although China has launched a series of regulations to establish a proper regulatory framework that facilitates the development of cell therapy products, the regulatory framework has not been able to meet the country's regulatory requirements. This article introduced the development of regulation and current regulatory pathways for cell therapy in China and identified the main challenges in clinical studies. China has recently tightened its policy on cell therapy clinical studies after medical chaos occurred in the area of cell therapy over the past few years. Currently the regulatory jurisdiction between NMPA and NHC are not very clear, especially for clinical somatic cell research, further efforts are necessary to establish a legislative system with a clear and functional regulatory framework for cell therapy.
近年来，细胞治疗的基础研究和临床开发取得了显著进展。尽管中国已经出台了一系列法规，建立了适当的监管框架，以促进细胞治疗产品的发展，但该监管框架仍未能满足国家的监管要求。本文介绍了中国细胞治疗监管的发展现状和现行监管途径，并确定了临床研究中的主要挑战。近年来，细胞治疗领域出现了医疗乱象，中国近期也加紧了对细胞治疗临床研究的政策。目前，NMPA 和 NHC 之间的监管权限尚不明确，特别是对于临床体细胞研究，需要进一步努力建立一个立法体系，为细胞治疗提供明确和功能健全的监管框架。
