总局关于药物临床试验数据自查核查注册申请情况的公告（2017年第128号）

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总局关于药物临床试验数据自查核查注册申请情况的公告（2017年第128号）

2017年10月30日 发布

国家食品药品监督管理总局决定对新收到42个已完成临床试验申报生产或进口的药品注册申请（见附件）进行临床试验数据核查。现将有关事宜公告如下：　　一、在国家食品药品监督管理总局组织核查前，药品注册申请人自查发现药物临床试验数据存在真实性问题的，应主动撤回注册申请，国家食品药品监督管理总局公布其名单，不追究其责任。　　二、国家食品药品监督管理总局食品药品审核查验中心将在其网站公示现场核查计划，并告知药品注册申请人及其所在地省级食品药品监管部门，公示10个工作日后该中心将通知现场核查日期，不再接受药品注册申请人的撤回申请。　　三、国家食品药品监督管理总局将对药物临床试验数据现场核查中发现数据造假的申请人、药物临床试验责任人和管理人、合同研究组织责任人从重处理，并追究未能有效履职的食品药品监管部门核查人员的责任。　　特此公告。　　附件：42个药物临床试验数据自查核查注册申请清单

http://www.sfda.gov.cn/WS01/CL0087/215872.html

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AstraZeneca, BMS and J&J Chosen for CFDA’s Data Verification Drive

CFDA has included products from AstraZeneca, Bristol-Myers Squibb and Johnson & Johnson in its latest clinical trial data verification drive. The agency initiated the probes as part of its ongoing attempt to identify and weed out applications based on substandard or fraudulent data.

In keeping with CFDA’s earlier assessments, the list of trials set to be evaluated by the regulatory agency is skewed toward those supporting the importation of drugs from multinational companies.

Eight of the 42 items on CFDA’s list relate to selexipag, a pulmonary arterial hypertension therapy J&J acquired in its takeover of Actelion. Another four items relate to dapagliflozin. AstraZeneca and Bristol-Myers developed the SGLT2 inhibitor for use in the treatment of diabetes and submitted filings for it to CFDA earlier this year. Another Western company, The Medicines Company, is also on the list.

Earlier batches of companies selected for data verification have featured the same types of drug developers. AstraZeneca, Bristol-Myers and J&J have all been through the process before. On those occasions, the companies were reviewed alongside peers such as Merck and Sanofi.

CFDA Notice (Chinese)

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