School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang, China.
Front Public Health. 2023 Dec 1;11:1265756. doi: 10.3389/fpubh.2023.1265756. eCollection 2023.
In March 2016, the Chinese government officially launched a nationwide consistency evaluation of the quality and efficacy of generic drugs.
This paper conducted an empirical study using the Difference-in-Differences method to explore the effect of this policy on the innovation quality of China's pharmaceutical manufacturing industry and further analyzed the underlying mechanism of action.
The results of the study show that the generic consistency evaluation policy has a significant promotion effect on the innovation quality of China's pharmaceutical manufacturing industry, and the promotion effect is the largest for non-state-owned enterprises and enterprises in the central region; in addition, the intensity of R&D capital investment and R&D personnel investment which play a mediating role.
Therefore, we should fully recognize the positive effect of generic drug consistency evaluation policy on improving the innovation quality of the pharmaceutical manufacturing industry and pay attention to the necessity of regional coordination and unification in policy implementation and the formulation of supporting policy tools. This study provides empirical evidence for the implementation effect of the generic drug consistency evaluation policy, which can provide an essential reference for the further improvement of the procedure and the R&D decision-making of pharmaceutical enterprises.
2016 年 3 月，中国政府正式启动了全国范围内的仿制药质量和疗效一致性评价工作。
本文采用双重差分法进行实证研究，探讨该政策对中国制药制造业创新质量的影响，并进一步分析其作用机制。
研究结果表明，仿制药一致性评价政策对中国制药制造业创新质量具有显著的促进作用，对非国有企业和中部地区企业的促进作用最大；此外，研发资本投入和研发人员投入的强度在其中发挥了中介作用。
因此，我们应该充分认识到仿制药一致性评价政策对提高制药制造业创新质量的积极作用，并重视政策实施和配套政策工具制定中的区域协调和统一的必要性。本研究为仿制药一致性评价政策的实施效果提供了经验证据，可为进一步完善程序和制药企业研发决策提供重要参考。
