In July 2024, the U.S. Food and Drug Administration (FDA) released final guidance clarifying the use of electronic health records (EHR) and claims data as real-world data (RWD) in drug and biological product regulation. The guidance outlines frameworks for data source selection, study design, data quality control, and validation methods. Aligning with the 21st Century Cures Act and the Prescription Drug User Fee Amendments, it is also a revision of the 2021 draft guidance. The guidance emphasizes the relevance and completeness of data sources and offers specific recommendations for data quality assessment. This initiative provides valuable insights for Chinese regulatory practices, particularly in digital transformation, drug development, pharmacoeconomic evaluation, integration of traditional Chinese medicine, and regulatory technology. It also highlights the need for enhanced data-driven regulatory systems and risk management, offering new directions for improving China′s competitiveness in the global pharmaceutical market.