In order to guide and support development entities in fully incorporating the patients' voices throughout the entire process of rare disease drug development, and to promote patient-centered drug development and marketing authorization for rare diseases, the CDE has organized the formulation of the Patient-Centered Action for Rare Diseases Encouragement ("CARE Plan"). With the approval of the NMPA, the CARE Plan is hereby issued and shall come into effect as of the date of issuance.

Center for Drug Evaluation, NMPA

September 13, 2024