The Guidelines on Design and Protocol of Drug Real-World Evidence Study (Trial) applies to the clinical evidence aquired from real-world study for drug evaluation. 

The applicability of real-world evidence (RWE) in supporting drug R&D and regulatory decision is specified in the Guidelines for Real-world Evidence Supporting Drug R&D and Review (Trial). 

The Guidelines on Design and Protocol of Drug Real-World Evidence Study (Trial) can also be a reference for real-world study that does not aim for drug registration.