Discussion of common communication problems and review considerations of therapeutic recombinant protein biologics
KAN Hong-jin
WEI Wei
CHENG Su-yuan
Abstract：In this paper,we have sorted out the relevant guidance documents on communication at home and abroad,summarized the communication situation of therapeutic biologics in recent years,discussed the common problems of communication at various stages in light of the review experience,and put forward some suggestions on how to improve communication from the applicant and regulatory level,with a view to improving the quality and efficiency of communication and laying a foundation for the smooth progress of the review and approval.
Keywords：recombinant proteins for therapeutic usebiological productscommunication
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 590-595 )