Abstract

Objective: Drug Evaluation & Approval System Reforming (EASR) is a major initiative of the State Council’s “Delegate power and optimize service” and “random inspection and information disclosure” policies in the R&D of pharmaceutical industry. The research aims to analyze the impact of drug EASR on the Chinese pharmaceutical organizational structure since 2015. Methods: Based on the relationship analysis between EASR and the organization structure of the government and pharmaceutical industry, this paper uses the Panel Data model to analyze the relevant factors affecting the R&D organizational structure. Results and Conclusion: The results show that it is significantly and positively correlated between the clinical trial behavior and the technology incubator, the domestic technology transfer and the technology macro environment. The organizational structure optimization path of the pharmaceutical industry based on the EASR includes the specialized division, big data model, international cooperation, MAH and technology finance model.

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