备受业内关注与期待的《药品上市许可持有人制度试点方案》(以下简称试点方案)于日前经国务院同意发布,这是继国务院《关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号),以及全国人大常务委员会《关于授权国务院在部分地方开展药品上市许可持有人制度试点和有关问题的决定》发布后,有关上市许可持有人制度真正落地的标志性文 The Pilot Program for the Drug Licensing System (hereinafter referred to as the “Pilot Scheme”), which has received much attention and expectations from the industry, was released on the consent of the State Council a few days ago. This is the second “Opinion of the State Council on Reforming the Examination and Approval System for Pharmaceutical and Medical Devices” [2015] No. 44) and the Decision of the Standing Committee of the National People’s Congress on “Authorizing the State Council to Pilot Licensing of Pharmaceutical License Holders in Some Areas and Relevant Issues”, the landmark system for listing license holders Text