Policy text analysis of China's smart pharmaceutical regulation under a policy tool-policy stage framework

Smart pharmaceutical regulation has emerged as a key approach to enhancing regulatory capacity and ensuring drug safety in the context of digital government. However, existing studies have largely focused on technological applications or descriptive policy analyses, with limited attention to the structural characteristics and evolution of policy instruments. To address this gap, this study applies a two-dimensional analytical framework that integrates policy instruments and policy development stages to examine China's smart pharmaceutical regulation policies. Drawing on a dataset of 90 policy documents issued between 2007 and 2026, the study employs a content-analysis approach, using the Nodality, Authority, Treasure, and Organization (NATO) framework to classify policy instruments and NVivo software to support systematic coding. The findings showed that nodality-based instruments constitute the largest share of the policy texts, reflecting a strong policy emphasis on data-driven governance, information sharing, and digital regulatory capacities. Treasure-based instruments primarily focus on digital infrastructure and technical-capacity development, while authority-based instruments continue to play an important role alongside emerging digital regulatory tools. Conversely, organization-based instruments receive comparatively less emphasis in the policy text, particularly regarding institutional coordination and stakeholder co-governance. From a temporal perspective, the policy texts reflect a shift from informationization-oriented regulation toward digital integration and, more recently, toward lifecycle-based and intelligence-oriented regulatory arrangements. Nevertheless, structural imbalances in the distribution of policy instruments remain evident within the policy corpus. The findings suggest the importance of strengthening interagency coordination, stakeholder participation, and the integration of technological and institutional governance mechanisms in future policy design. This study contributes to the literature by providing a systematic policy text analysis of smart pharmaceutical regulation and offering insights into the evolving structure of regulatory governance in the digital age.