Comparison of application procedures and expedited programs of advanced therapy medical products in China and the United States
YIN Hui-fang
LI Xiao-fen
QIN Xiao-yan
SU Yi-gang
FAN Jie
FAN Yi
Abstract：In recent years,advanced therapies have ascended to be among the most prominent fields.With the continuous emergence of technological innovations,which,while conferring disruptive benefits,have also led to a market boom.Under the backdrop of the global convergence of advanced therapy regulations,an increasing number of domestic advanced therapy companies have initiated overseas expansion and exploration of the international market.Meanwhile,overseas advanced therapeutic companies are accelerating their entry into China.Under the premise of the mutual recognition of clinical data between China and the United States,for most Chinese pharmaceutical companies,the earlier the dual-filings in China and the United States,the more conducive to improving the speed of drug marketing and occupying the international market as soon as possible.Owing to the different regulatory systems among different countries,there exist numerous differences in the application process and application policies.This paper integrates the relevant regulations and guidelines of China and the United States,with a focus on the definition and classification of advanced therapy medical products,regulatory agencies,application processes,expedited programs,and application data format requirements.The objective is to provide references for domestic and foreign pharmaceutical enterprises and research institutions in the international application strategy development and product planning and promote the global research and development and application of advanced therapy medical products.
Keywords：advanced therapy medical productsdual-filings in China and the United Statesapplication processexpedited programsapplication data format
Publication Date：2025-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：12( 811-822 )