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On December 25, 2025, Lei Ping, a member of the party group and deputy director of the State Drug Administration, visited Peking Union Medical College Hospital to investigate and learn about the pilot situation and clinical transformation of the hospital's own development and use of in vitro diagnostic reagents by medical institutions. Lei Ping pointed out that the homemade reagent pilot is a pioneering work. In particular, it can provide valuable diagnostic tools for rare diseases, difficult diseases, and diseases for which there is no effective clinical diagnosis method, which is of great significance. Peking Union Medical College Hospital should give full play to the leading role of high-level hospitals and actively carry out research and development and transformation of products that are urgently needed clinically. The State Drug Administration is exploring ways to use real-world data on homemade reagents to support effective evaluation of product safety, clarify relevant technical requirements based on product risk, and promote rational application of real-world data on the premise of ensuring data quality and sufficient evidence to meet clinical use requirements.

Zhitongcaijing·12/26/2025 10:49:04
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On December 25, 2025, Lei Ping, a member of the party group and deputy director of the State Drug Administration, visited Peking Union Medical College Hospital to investigate and learn about the pilot situation and clinical transformation of the hospital's own development and use of in vitro diagnostic reagents by medical institutions. Lei Ping pointed out that the homemade reagent pilot is a pioneering work. In particular, it can provide valuable diagnostic tools for rare diseases, difficult diseases, and diseases for which there is no effective clinical diagnosis method, which is of great significance. Peking Union Medical College Hospital should give full play to the leading role of high-level hospitals and actively carry out research and development and transformation of products that are urgently needed clinically. The State Drug Administration is exploring ways to use real-world data on homemade reagents to support effective evaluation of product safety, clarify relevant technical requirements based on product risk, and promote rational application of real-world data on the premise of ensuring data quality and sufficient evidence to meet clinical use requirements.