The Platform Technology Designation Program for Drug Development Guidance for Industry of the United States and its implications for the regulation of cell and gene therapy in China
MA Qiao-ning
SUN Tan-lin
WANG Wen-ya
Abstract：The US FDA has recently issued the Platform Technology Designation Program for Drug Development Guidance for Industry,providing a new avenue for improving the efficiency of drug development,manufacturing,and review processes.The guidance elaborates on key elements such as the application conditions for platform technology designation,potential benefits,data utilization,discussions in milestone meetings,application content,and the review schedule.This guidance offers important insights for the regulation of cell and gene therapy(CGT)in China.Chinese regulatory agencies can draw on American experience to establish a similar framework for the designation of platform technology,strengthen communication between regulatory agencies and enterprises,and promote international exchange of experiences,in order to advance innovation and standardized development in the CGT industry,and enhance patient access to advanced medical products.
Keywords：US FDAplatform technology designationdrug developmentregulatory sciencecell and gene therapy
Publication Date：2025-02-27
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 337-340 )