The impact of the consistency evaluation policy of generic drugs on the integration of innovation chain and industrial chain in the pharmaceutical manufacturing industry

IntroductionThe Consistency Evaluation Policy of Generic Drugs is a major quality-oriented regulatory reform in China’s pharmaceutical manufacturing industry. Whether and how this policy facilitates the integration of the innovation chain and the industrial chain at the enterprise level remains insufficiently examined. This study evaluates the policy effect and investigates potential mechanisms.MethodsThis study used panel data on A-share listed pharmaceutical enterprises from 2013 to 2023. Enterprises were treated as the micro-level carriers of both the innovation chain and the industrial chain, and a enterprise-level index was constructed to measure their integration. A difference-in-differences (DID) design was employed to estimate the impact of the Consistency Evaluation Policy of Generic Drugs. Mechanism analyses focused on government subsidies and market concentration, and heterogeneity was assessed by market demand and total factor productivity (TFP).ResultsThe Consistency Evaluation Policy of Generic Drugs significantly promoted the integration of the innovation chain and the industrial chain. Mechanism tests suggested that the effect operated through two channels: increased government subsidies and higher market concentration. The positive effect was stronger among enterprises facing larger market demand. Moreover, the effect was significant for enterprises with higher TFP, while it was not statistically significant for enterprises with lower TFP.DiscussionThese findings suggest that policy implementation can be strengthened by (1) improving the depth and precision of the Consistency Evaluation Policy of Generic Drugs, (2) enhancing the targeting of government subsidies and supporting an appropriate degree of industry concentration where warranted, and (3) adopting differentiated guidance to stimulate enterprise vitality through multiple measures.