The Center for Drug Evaluation (CDE) has issued a notification regarding the patient-centric rare disease drug research and development (R&D) working plan filing guidelines and implementation framework. The document is open for public comments for a period of one month. The objective of these guidelines is to guide and assist R&D entities in integrating patient perspectives throughout the drug development process. This approach aims to enhance the scientific, standardized, and rational incorporation of patient experience data into the clinical research and development of rare disease drugs, thereby promoting the high-quality and efficient development and marketing of such medications.
The implementation framework delineates the drug R&D process into five distinct stages, encompassing the entire lifecycle of drug R&D. These stages include:
- Stage A: R&D Project Initiation Stage
- Stage B: Pre IND Stage, prior to clinical trial implementation
- Stage C: Key Pre-Research Stage
- Stage D: Pre NDA/NDA Stage
- Stage E: Post Listing Stage
Each stage has different inclusion criteria (see table below). Based on voluntary participation, applicants are required to submit an application to the CDE, requesting to join the corresponding stage based on the drug’s R&D phase. It is anticipated that 1-2 varieties in each stage will be selected for inclusion, with the CDE choosing representative varieties to feature in the working plan.- Flcube.com
