A study on the dilemma and countermeasures of drug off-site inspection in China
ZHANG Jie-ying
LI Jun
ZHAO Feng
FAN Rui-xue
ZHANG Miao-miao
MAO Ning-ying
Abstract：Drug off-site inspection has become an important trend in the development of drug regulatory innovation. It plays a positive role in the improvement of drug inspection efficiency and effectiveness to a certain extent. The Delphi method was used in this study to interview senior inspectors from various professional fields of drug inspection,as well as enterprise managers who had undergone off-site drug inspections. The dilemmas in off-site drug inspection work,mainly including institutional dilemmas,technical dilemmas,and trust dilemmas,were identified and analyzed. Strategies are proposed to accelerate the introduction of institutional normative documents,clarify the scope of application,build supporting information technology platforms and facilities,improve the professional quality of drug inspectors,and establish data confidentiality mechanisms,which is of help to truly empower off-site inspection technology and promote the modernization of the smart regulatory scientific system.
Keywords：off-site inspectiondrugdilemmaregulatory scientific system
Publication Date：2025-01-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 20-26 )