兒童藥品臨床綜合評(píng)價(jià)作為上市后再評(píng)價(jià)的一種規(guī)范管理形式，從多維度全面評(píng)價(jià)兒童藥品的綜合價(jià)值，通過(guò)專家組打分進(jìn)行指標(biāo)賦分和分值計(jì)算，最終形成推薦意見，為兒童藥品管理決策提供有力的支撐，優(yōu)化醫(yī)療資源的配置、保障兒童藥品安全。目前我國(guó)兒童藥品臨床綜合評(píng)價(jià)機(jī)制包括出臺(tái)了專門的管理指南和評(píng)價(jià)技術(shù)指南，采用多維度評(píng)價(jià)標(biāo)準(zhǔn)，采用多種評(píng)價(jià)方法，確立結(jié)構(gòu)化的評(píng)審流程。我國(guó)兒童藥品臨床綜合評(píng)價(jià)體系正在逐步構(gòu)建和完善中，存在立法不完善、評(píng)價(jià)維度不統(tǒng)一、臨床創(chuàng)新性界定模糊、真實(shí)世界數(shù)據(jù)機(jī)制和評(píng)價(jià)結(jié)果轉(zhuǎn)化機(jī)制不完善等問(wèn)題，導(dǎo)致評(píng)價(jià)工作與實(shí)際藥品監(jiān)管和藥品供應(yīng)保障之間脫節(jié)。為應(yīng)對(duì)未來(lái)挑戰(zhàn)，應(yīng)從加強(qiáng)立法、合理選擇評(píng)價(jià)維度、完善兒童藥品創(chuàng)新性評(píng)估體系、健全真實(shí)世界數(shù)據(jù)機(jī)制、建立有效的評(píng)價(jià)決策支持機(jī)制等方面完善兒童藥品臨床綜合評(píng)價(jià)體系，從而解決兒童用藥保障問(wèn)題、提升兒童健康水平。

As a standardized management form of post-marketing reevaluation, clinical comprehensive evaluation of pediatric drugs conducts multi-dimensional assessment of their comprehensive value. Through expert panel scoring for indicator weighting and score calculation, it ultimately forms recommendation opinions. This process provides strong support for pediatric drug management decisions, optimizes allocation of medical resources, and ensures medication safety for children. Current clinical evaluation mechanisms in China include issuing specialized management guidelines and technical evaluation standards, adopting multidimensional evaluation criteria, utilizing various assessment methods, and establishing structured review processes. While China's clinical comprehensive evaluation system for pediatric drugs is gradually being established and improved, existing challenges include incomplete legislation, inconsistent evaluation dimensions, ambiguous definitions of clinical innovation, inadequate real-world data mechanisms, and imperfect evaluation result transformation systems. These issues lead to disconnections between evaluation practices and actual drug regulation/supply systems. To address future challenges, improvements should focus on strengthening legislation, rationally selecting evaluation dimensions, perfecting pediatric drug innovation assessment systems, optimizing real-world data mechanisms, and establishing effective evaluation decision-support mechanisms. This comprehensive approach aims to resolve pediatric medication security issues and enhance child health outcomes.

R97

北京市社會(huì)科學(xué)基金項(xiàng)目-北京共建共治共享的藥品安全治理體系研究（19GLB032）