Drug Safety Governance: Framework and Development Path

摘要

Objective: The necessity of shifting from management to governance of drug safety has gained a wide consensus in both academic and practical circles, but how to act and develop has not been adequately discussed and become a key issue that needs to be addressed nowadays. This article combines the theoretical essence of governance to establish an analytical framework of “initial conditions-joint action-governance effectiveness” based on governance theory to analyze and explain the connotation and mechanism of cross-sector cooperative governance of drug safety. Methods: The essence of governance lies in the creation of joint action capabilities through cross-sector cooperation, as well as the construction of a national drug safety governance action framework of “3 stages + 1 incubation period”. This article analyzes the connotation of each stage and possible problems or obstacles. Results: Three deep-seated challenges stem from the lack of information sharing, resource action sharing, and power sharing. Conclusion: In order to improve the modernization construction of China’s drug safety governance system and capacity, it is recommended to continuously improve Chinese drug safety governance in terms of governance norms, communication mechanisms, capacity development, and cross-sector coordination based on a holistic perspective.