The Guidelines on Real-world Evidence Supporting Drug R&D and Review (Trial) is aimed at 

• clarifying real-world evidence (RWE)'s definition in drug R&D and regulatory decisions; 

• providing guidance for collecting real-world data (RWD) and evaluating its applicability;

• specifying the RWE's position and application scope in drug regulatory decisions;

• exploring the principles for evaluating RWE;

• offering advice for the industry and regulators to make drug regulatory decisions by using RWE.

The guidelines only represent the current knowledge and opinions, and will be revised and improved with further researches and knowledge.