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国务院办公厅文件国办发[2016]41号各省、自治区、直辖市人民政府,国务院各部委、各直属机构:《药品上市许可持有人制度试点方案》已经国务院同意,现予印发。开展药品上市许可持有人制度试点是药品审评审批制度改革的一项重要内容,对于鼓励药品创新、提升药品质量具有重要意义。各有关地区要高度重视,按照试点方案要
State Council General Office Document Guo Ban Fa [2016] No. 41 People’s Governments of provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions under the State Council and all directly subordinate agencies: The Pilot Program for the System of Pharmaceutical License Holders has been approved by the State Council and is now being issued. Piloting the system of drug listing license holders is an important part of the reform of drug approval system, which is of great significance to encouraging drug innovation and improving drug quality. The relevant regions should attach great importance to the pilot program to be