Abstract
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.
Highlights
In the century-long history of drug regulation in human society, the reform of drug safety regulatory system has almost always been problem-driven
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
The adoption of the governance model undoubtedly points the way to the reform of the already increasingly weak government-underwritten drug safety regulatory system
Summary
Most of the existing researches focus on theoretical descriptions and discussions of the logic and public values of drug safety governance, which are enlightening but fail to reveal the direction and concrete path of drug safety governance reform in China under the new situation. It weakens the application value and influence of the research results. The core proposition of this paper is to construct a framework for action on drug safety governance in China based on theory and policy practice, to clarify the key issues or obstacles that should be broken through at different stages of governance and to propose recommendations for improvement
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