Exploration of the full life cycle management of drug guidance by the U.S.FDA and its inspiration to China
SUN Tan-lin
MA Qiao-ning
XU Zhen-yu
Abstract：In the process of drug research and development,registration,production,supervision,inspection and verification,guidance plays a dual role of regulatory basis and technical requirements.Improving the full lifecycle management of guidance helps to form a scientific,open,transparent,and socially participatory standard system.The guidance of the FDA can be traced back to 1902.FDA introduced the Good Guidance Practice(GGP)in 1997,which clarifies the nature and effectiveness of guidance principles at the regulatory level and standardizes the process of formulation and revision.FDA released reports in 2011 and 2023,summarizing the phased implementation progress of GGP by FDA and various centers/offices,and plans to further optimize and form Best Practices for Guidance.This study combines the formation and update trajectory of FDA-issued guidance to sort out the current situation of FDA's initiation,drafting,review,release,and update of guidance,providing reference ideas for the full lifecycle management of guidance in China.
Keywords：drug regulationguidanceregulatory science
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：7( 370-376 )