Jiang Mengjuan, Huang Jingjing, Wang Su, Fan Yulu, Chen Yuwen
School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
College of Pharmacy, Shanghai University of Medicine & Health Sciences, Shanghai, China.
Front Public Health. 2025 Jul 30;13:1512148. doi: 10.3389/fpubh.2025.1512148. eCollection 2025.
In October 2017, China initiated adjustments to the registration procedures for imported drugs to promote accessibility to overseas drugs. In support of this decision, the National Medical Products Administration (NMPA) issued a technical guideline regarding accepting foreign clinical trial data in July 2018. Collectively referred to as the accepting foreign clinical data policy, these measures have accelerated the influx of overseas drugs into China.
Using the panel data from 104 A-share pharmaceutical listed firms between 2013 and 2024, this study conducted a difference-in-differences model to explore the impact of this policy on the innovation investment of Chinese pharmaceutical firms and further analyzed the underlying moderating effect.
The results demonstrate a significantly positive effect of this accepting foreign clinical data policy on pharmaceutical firms' innovation investment, which is verified with the parallel trend and robustness tests. Further analysis indicates that corporate absorptive capacity positively moderates the relationship between the policy implementation and innovation investment. In addition, the heterogeneity analysis suggests that this policy has a more significant effect on firms that are non-state-owned, engage in new drug research and have strong market power.
This study serves as a significant supplement to the current literature regarding the accepting foreign clinical data policy and innovation investment, providing valuable insights for policymakers and R&D decision-makers in the pharmaceutical sector.
2017年10月，中国启动了进口药品注册程序调整，以促进海外药品的可及性。为支持这一决定，国家药品监督管理局（NMPA）于2018年7月发布了一项关于接受国外临床试验数据的技术指南。这些措施统称为接受国外临床数据政策，加速了海外药品涌入中国。
本研究利用2013年至2024年间104家A股上市制药公司的面板数据，采用双重差分模型探讨该政策对中国制药公司创新投资的影响，并进一步分析潜在的调节效应。
结果表明，接受国外临床数据政策对制药公司的创新投资具有显著的正向影响，这在平行趋势和稳健性检验中得到了验证。进一步分析表明，企业吸收能力对政策实施与创新投资之间的关系具有正向调节作用。此外，异质性分析表明，该政策对非国有企业、从事新药研发且具有较强市场势力的公司影响更为显著。
本研究是当前关于接受国外临床数据政策与创新投资文献的重要补充，为制药行业的政策制定者和研发决策者提供了有价值的见解。
