Combating substandard and falsified medicines in China:policy barriers and the role of pharmaceutical track-and-trace systems

Substandard and falsified medicines (SF medicines) pose a severe threat to population health and safety. China has a large proportion of SF medicines, imposing a heavy economic burden and exacerbating inequities in access to quality medications. Addressing this issue urgently is critical to safeguarding public health. This study reviews the relevant literature to summarize the causes of SF medicines based on the Chinese pharmaceutical supply chain. Meanwhile, we scrutinized current Chinese policies to identify gaps in the existing responses. Finally, the feasibility of the pharmaceutical track-and-trace system implemented in China was evaluated and compared with the international experience. Analysis reveals that supply chain vulnerabilities are the primary risk to medical security, with track-and-trace systems (PTTS) emerging as an irreplaceable tool for real-time monitoring to mitigate SF medicines’ risks and ensure end-to-end quality assurance. While the Chinese government has committed to PTTS adoption, challenges remain in political economy and social acceptance. Therefore, recommendations include strengthening policy enforcement, conducting health economic evaluations of PTTS, and enhancing public awareness to eliminate SF medicines effectively.