论文部分内容阅读
日前发布的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(以下简称《意见》),对儿童专用药(以下简称儿药)注册申请人提交的自行取得且未披露的试验数据和其他数据,给予一定的数据保护期新政,受到儿药生产企业的热烈欢迎。四川百利药业有限责任公司研发中心副总经理丁洋表示,《意见》将激发儿药企业的创新热情,热切期待政策尽快落地。近年来,鼓励儿药创新研发,提高儿药可及性备受社会关注。2013年,儿药优先审评审批改革摆上国家食品药品监督管理总局的议事日程。作为改革的
The recently released Opinions on Deepening the Innovation of Examination, Approval and Approval System to Encourage the Innovation of Medicinal Medical Devices (hereinafter referred to as Opinions), the self-obtained and undisclosed test data submitted by the applicant for registration of pediatric drug (hereinafter referred to as pediatric medicine) And other data, given a certain data protection period of the New Deal, by the children’s medicine manufacturing enterprises a warm welcome. Ding Yang, deputy general manager of Sichuan Bailey Pharmaceutical Co., Ltd. R & D Center, said the Opinions will stimulate the enthusiasm for innovation in the pharmaceutical enterprises and look forward to the policy as soon as possible. In recent years, encouraging children’s medicines to innovate in research and development and raising the accessibility of children’s medicines has drawn much public attention. In 2013, the review and approval of priority drug review put the agenda of the State Food and Drug Administration. As a reform