ICMRA 的 PQKM 项目在其试点推进中达成一项重要里程碑，两项试点的初始阶段已于2024年5月完成。试点于2022年7月启动，总体目标是提升高优先级药品的生产制造能力，并推动多个监管机构联合开展质量评估与检查。相应地，这些努力有助于朝着实现 ICMRA 的愿景进一步迈进，即在生产生命周期管理的背景下，推动各参与监管区域在评估与检查活动中实现更高程度的监管趋同，并最终走向监管依赖互认，总体目标是让患者更快地获得药品。
The ICMRA PQKM project has reached a major milestone in the progress of its pilot programmes, with the initial phase of both pilots having been completed in May 2024. The pilots commenced in July 2022 with the overall aim of improving manufacturing capacity for production of high priority medicines and facilitating collaborative quality assessments and inspections by multiple regulatory authorities. In turn, these efforts enable further progression towards realisation of ICMRA’s vision of greater regulatory convergence, and ultimately reliance, in assessment and inspection activities across participating regulatory regions in the context of manufacturing lifecycle management, with the overall aim to facilitate faster access to medicines for patients.