Based on the Provisions for Drug Registration and the Provisions for Communication About Drug R&D and Technical Review, the Guidelines on Communication About Drug Registration Supported by Real-world Evidence clarifies the core issues for dicussion and the materials for the meeting between CDE and the applicant who applies for drug registration by using real-world evidence (RWE). The guidelines provide advice to the applicant about the meetings' pivotal timings with the aim of making the clincial research more efficient.

The guidelines apply to the communication for the drug registration application with RWE as the critical evidence for efficacy and/or safety evaluation. Specific communication procedures shall abide by the Provisions for Communication About Drug R&D and Technical Review.