Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations. It plays a crucial role in promoting rational drug use and improving public health outcomes. High-quality pharmacoepidemiological research relies on rigorous methodological frameworks. Chinese Pharmaceutical Association (CPA) has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) in 2024. This revision project was supported by the Pharmacoepidemiology Committee of CPA, and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health, which provided methodological guidance, in collaboration with multidisciplinary experts from across the country. Building on the experience of the 1st edition’s development, the working group conducted a qualitative systematic review, to extract key information from global pharmacoepidemiology-related guidelines, laying the foundation for the development/revision proposals of the 2nd edition. Subsequently, through two rounds of Delphi method expert consultations and qualitative interviews, alongside extensive discussions within the working group, the draft revision of the guideline was created. Finally, through an expert consensus meeting using the Nominal Group Technique (NGT), a consensus was reached, resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China. The 2nd edition consists of 41 entries, including 8 primary entries, 20 secondary entries, and 13 tertiary entries. It comprehensively covers key aspects such as study protocol development, study implementation, adverse event reporting, research report writing, and dissemination of study findings. Additionally, it addresses specific application scenarios and topics, as well as the application of artificial intelligence and real-world studies.

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