Core Viewpoint - The National Medical Products Administration (NMPA) is exploring the pilot program for self-manufactured in vitro diagnostic reagents, emphasizing its significance for rare and difficult diseases where effective diagnostic methods are lacking [1] Group 1 - The pilot program for self-manufactured reagents is considered a groundbreaking initiative that can provide valuable diagnostic tools for rare and difficult diseases [1] - Beijing Union Medical College Hospital is encouraged to leverage its status as a high-level hospital to actively engage in the research and transformation of urgently needed clinical products [1] - The NMPA is working on utilizing real-world data to support the safety and efficacy evaluation of these products, ensuring that data quality and evidence sufficiency are maintained [1]