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.
Highlights
Evaluation & Approval System Reforming (EASR) is influencing the innovative development track, the knowledge system of the pharmaceutical industry and the enhancement of core competitiveness
Based on the State Council’s “Delegate power and optimize service” and “random inspection and information disclosure” policies, it was raised by the Opinions of the State Council on Reforming the Evaluation and Approval System for Drug and Medical Devices in Aug. 2015 to “improve the quality of evaluation and approval” and “encourage R&D of new drugs”
The results of empirical research showed that: based on the output of pharmaceutical scientific and technological innovations under EASR, that is, from the perspective of the number of clinical trial applications, the number of technology business incubators from various provinces or cities were significantly and positively correlated with pharmaceutical innovation behavior; the number of science and technology service institutions had no correlation with pharmaceutical innovation behavior; the technical fee in introducing foreign technology and the cost of introducing foreign technology into pharmaceutical industry had no correlation with the pharmaceutical innovation behavior; the cost of purchasing domestic technology was significantly and positively correlated with pharmaceutical innovation behavior; the number of contracts in technology transaction market was significantly and positively correlated with pharmaceutical innovation behavior
Summary
Evaluation & Approval System Reforming (EASR) is influencing the innovative development track, the knowledge system of the pharmaceutical industry and the enhancement of core competitiveness. Based on the State Council’s “Delegate power and optimize service” and “random inspection and information disclosure” policies, it was raised by the Opinions of the State Council on Reforming the Evaluation and Approval System for Drug and Medical Devices in Aug. 2015 to “improve the quality of evaluation and approval” and “encourage R&D of new drugs”. Government institutional reform, two-invoice system and EASR are working together on organizational structure adjustment, innovation progress and performance appraisal; measures of EASR such as MAH (Marketing Authorization Holder) system, GQCE (Generic Quality Consistency Evaluation) and international multi-center clinical data recognition will surely accelerate the course of the Chinese government’s functions’ transformation and industry’s organizational structure adjustment and optimization
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