Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions. Despite significant efforts to establish standardized regulatory procedures, challenges remain, particularly in achieving a unified definition and application of platform technology across regions. This paper explores the evolution, applications, and regulatory strategies of platform technology, with a focus on China's experience in this field. China's approach, encompassing risk assessment, and the expedited approval of emergency vaccines, offers valuable insights into global regulatory coordination. By analyzing China's regulatory contributions and international practices, this paper highlights the potential of platform technology to address future pandemics, including "Pathogen X", and underscores the importance of harmonizing global regulatory efforts to strengthen public health preparedness and response.