Regulation of cellular and gene therapies at home and abroad

doi:10.19803/j.1672-8629.20240160

Abstract

Abstract: Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry. Methods The ways in which cellular and gene therapy products were regulated in the US, Japan and Europe were compared by reviewing regulations and literature. The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development. Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States, Japan and Europe, China's regulatory system can be upgraded by means of innovative regulatory concepts, integration of review resources, more international exchanges and cooperation as well as intensified efforts.

Key words: cellular, gene, therapy, FDA, EMA, PMDA, regulatory, review, approval

CLC Number:

R951
R915

ZHAO Peipei, WEN Baoshu. Regulation of cellular and gene therapies at home and abroad[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1019-1024.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240160

https://zgywjj.magtechjournal.com/EN/Y2024/V21/I9/1019

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