The Center for Drug Evaluation has unveiled the ‘Pilot Work Plan for Patient-Centered Action for Rare Diseases Encouragement (CARE),’ following a public consultation period in May 2024. The final document retains the initial proposal’s structure, segmenting the drug R&D lifecycle into stages A through E, with the anticipation of including 1-2 drug varieties in each stage.
The official document introduces minor refinements, notably in stage C: Key Pre-Research, where an additional requirement for ‘Research Plan/Report on Patient Experience Data in Key Clinical Trials (if applicable)’ has been included. Furthermore, innovative criteria have been established to prioritize products utilizing digital health technology during stages B-C. The document also modifies the conditions for ‘C or D stage varieties’ to participate in an accelerated review process. The draft proposal now specifies that only D stage varieties can engage with the CDE based on preliminary results and datasets, aiming to facilitate the earliest possible initiation of clinical data review by the CDE. – Flcube.com
