Analysis of the characteristics and optimization path of regulatory scientific research in the field of cell gene therapy in China
SUN Tanlin
Abstract：Regulatory science research drives high-level studies and efficient translation in China's pharmaceutical regulatory science through innovations in regulatory tools,standards,and methodologies.Regulatory agencies play a crucial role in this process.This paper focused on the field of cell and gene therapy,analyzing articles published by relevant national pharmaceutical regulatory institutions to explore the current regulatory science research ecosystem in China and the role of regulatory agencies within this domain.Based on these findings,we propose optimization suggestions to promote the development of regulatory science research,enhance pharmaceutical regulatory capabilities,and accelerate the market entry of innovative products.
Keywords：Drug regulationRegulatory scienceCell and gene therapy
Publication Date：2026-01-30
Online Publishing Date：2026-03-24(First online date of this platform, not the publication date of the document)
Pages：7( 40-46 )