The Center for Drug Evaluation (CDE) has released a notification regarding the “Real-World Evidence (RWE)-backed Drug Registration Application Communication Guidelines” (draft proposal). The draft is open for public feedback for one month. The aim is to provide specific requirements and guiding suggestions for communication between the applicant and the review agency to support registration applications with real-world evidence.
Background
With the release of real-world evidence and real-world data guidelines, applicants have become more active in conducting real-world research. Communication with the CDE about conducting such research has also increased. The drafting group of the guideline is based on the tripartite academic coordination committee established by the CDE and Southern Medical University. The committee was initiated in March 2022 and held two expert seminars in March and May. These seminars fully discussed the first draft, which was reviewed internally by the CDE to form the draft proposal.
Core Issues Discussed
The core issues discussed at the communication meeting include:
- Consideration of the necessity and feasibility of conducting real-world research
- Clarifying the key elements of the research plan involved in communication
- Focusing on the applicability of real-world data
- The transparency of conducting real-world research
Materials Requirements
Materials requirements pivot around the research implementation process. They clarify the relevant documents and specific requirements that should be prepared for communication prior to research implementation, during the research, and before submitting the registration application.-Fineline Info & Tech
