Asian Journal Of Social Pharmacy

Abstract: Objective To provide a reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. Methods The main content of “Real-World Evidence Program Framework” issued by the FDA was summarized by literature research method, and the related system construction in China was analyzed. Results and Conclusion To promote the use of real-world study (RWS) for drug regulatory decisions, China should issue guidelines on RWS. Besides, the construction of data standards and the shared database should be strengthened. Then, the demonstration projects should be introduced extensively and the guidance for RWS of enterprises must be enhanced. Meanwhile, close attention should be paid to dealing with the relationship between stakeholders.

Key words: FDA, real-world data, real-world evidence, enlightenment