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为进一步加强医疗器械临床试验监督管理,北京市食品药品监督管理局将对医疗器械临床试验数据真实性、合规性开展监督检查,查处临床试验违法违规行为,强化申请方、注册申请人、代理人和临床试验机构的法律意识,诚信意识、责任意识和质量意识。现将有关事项通告如下:一、检查范围2016年—2017年度,北京市医疗器械临床试验监督检查采用针对性检查的方式,对我市2016年9月30前开展的临床试验项目实施抽查。具体范围为:(一)医疗器械临床试验备案的项目;(二)通过临床试验方式获取临床试验数据的第二类医疗器械产品注册申请项目;
In order to further strengthen the supervision and administration of clinical trials of medical devices, Beijing Food and Drug Administration will supervise and inspect the authenticity and compliance of clinical trial data of medical devices, investigate and punish illegal activities in clinical trials, and strengthen the application, registration applicants and agents Legal awareness of people and clinical trials, honesty, responsibility and quality awareness. The relevant matters are hereby announced as follows: I. Scope of examination In 2016-2017, the supervision and inspection of clinical trials of medical devices in Beijing adopts a targeted inspection method to carry out spot checks on the clinical trial projects carried out in our city by September 30, 2016. The specific scope of the project is as follows: (1) Projects for the record of clinical trials of medical devices; (2) Application projects for the registration of the second type of medical device products that have obtained clinical trial data through clinical trial;