全国人民代表大会常务委员会:我受国务院委托,现对《关于授权国务院开展药品上市许可持有人制度试点和药品注册分类改革试点工作的决定(草案)》(以下简称草案)作说明。近年来,我国药品产业快速发展,药品质量不断提高,人民群众的用药需求得到较好保障。同时,现行药品审评审批制度与药品产业发展不相适应的问题也逐渐显现,突出表现为药品质量 Standing Committee of the National People’s Congress: As entrusted by the State Council, I hereby explain the “Decision on Authorizing the State Council to Conduct Pilot Pilot Work on Pharmaceutical Listing Licensees and Pilot Reform of Pharmaceutical Registration Classification (Draft)” (hereinafter referred to as the “Draft”). In recent years, the rapid development of China’s pharmaceutical industry, the continuous improvement of the quality of medicines, the people’s demand for medicines are better protected. At the same time, the existing drug review and approval system and the pharmaceutical industry is not compatible with the development of the problem has gradually emerged, highlighted the quality of medicines