Abstract

Against the backdrop of reforms in China's drug review and approval system, the process of technological structure adjustment, and accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) international mutual recognition agreements, China's pharmaceutical innovation "going global" model has gained opportunities for rapid development. Pharmaceutical innovation going global primarily encompasses three approaches: product export, technology licensing (license-out), and data cross-border compliance. From 2011 to 2023, sales of new products and product exports in China's pharmaceutical manufacturing industry maintained continuous growth. This study employs the Data Envelopment Analysis (DEA) method, with sales revenue from new product exports and patent applications as innovation output indicators, to analyze regional innovation "going global" efficiency. The results indicate that 7 regions—including the eastern region, Beijing, Tianjin, Shanghai, and Zhejiang—exhibit optimal scale efficiency, while the eastern region and three provinces (Jiangsu, Shandong, and Guangdong) show diminishing returns to scale. Except for Beijing, Tianjin, and provinces in the eastern region, most regions experience technical slack, export slack, and patent slack. Using a Panel Data model to examine the path of regional innovation "going global" technological structure adjustment, the findings reveal significant heterogeneity in the impact of technological transformation on pharmaceutical industry innovation "going global" following ICH accession. Notably, technology introduction exerts an inhibitory effect on pharmaceutical industry innovation "going global". Additionally, ICH international standards demonstrate provincial heterogeneity, with eastern provinces being more likely to benefit from ICH agreements. Therefore, it is imperative to actively participate in international regulatory coordination, advance technological structure adjustment for innovation "going global", and enhance technical support for international standard review and inspection, thereby promoting the healthy and sustainable development of the pharmaceutical innovation "going global" model.

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