Medical network - on September 14, the state food and drug administration and decision on the new received 22 completed clinical trials to declare manufactured or imported drug registration application (see attachment) for clinical trial data for verification. The relevant issues are hereby announced as follows:

One, in the administration of state food and drug supervision and administration organization before inspection, inspection found that the drug registration applicant drug clinical trial data authenticity problems, should take the initiative to withdraw the application for registration, the state food and drug supervision and administration bureau announced its list, shall be investigated for their responsibility.

Second, the state administration of food and drug supervision and administration of the food and drug audit inspection center will be published on its website that the inspection plan, and inform the applicant for drug registration and its local provincial food and drug regulatory authority, the public 10 working days after the centre will inform the inspection date, no longer accept drug registration the applicant's application for withdrawal.

Three, total bureau of national food and drug supervision and administration of drug clinical trial data will be found in the inspection data of the applicant for pharmaceutical clinical test shall be given heavier processing partners and managers, contract research organization partners, and failed to effectively takes office will be the responsibility of the food and drug regulatory inspectors.

Hereby notice.

Attachment: 22 clinical trial data of the drug to verify the registration application list

序号	省份	受理号	药品名称	申报人	分类
1	/	JXHS1700030	磷酸特地唑胺片	拜耳医药保健有限公司	进口
2	/	JXHS1700031	注射用磷酸特地唑胺	拜耳医药保健有限公司	进口
3	/	JXHS1700033	吸入用盐酸氨溴索溶液	韩美药品株式会社；北京韩美药品有限公司	进口
4	北京	CXSS1700012	23价肺炎球菌多糖疫苗	北京科兴生物制品有限公司	新药
5	北京	CXSS1700013	冻干b型流感嗜血杆菌结合疫苗	北京民海生物科技有限公司	新药
6	吉林	CXSS1700015	流感病毒裂解疫苗（四价）	长春长生生物科技有限责任公司	新药
7	江苏	CYHS1700055	注射用替莫唑胺	江苏恒瑞医药股份有限公司	仿制药
8	江苏	CYHS1700131	阿哌沙班片	正大天晴药业集团股份有限公司	仿制药
9	江苏	CYHS1700138	安立生坦片	正大天晴药业集团股份有限公司	仿制药
10	安徽	CYHB1703734	富马酸替诺福韦二吡呋酯片	安徽贝克生物制药有限公司	补充申请
11	山东	CYHS1700189	盐酸曲美他嗪缓释片	齐鲁制药有限公司	仿制药
12	湖北	CYHS1700136	氟比洛芬酯注射液	武汉大安制药有限公司	仿制药
13	广东	CYHS1600219	替格瑞洛片	深圳信立泰药业股份有限公司	仿制药
14	广东	CYHS1700112	头孢呋辛酯片	深圳信立泰药业股份有限公司	仿制药
15	广东	CYHS1700113	头孢呋辛酯片	深圳信立泰药业股份有限公司	仿制药
16	海南	CYHS1700147	盐酸普拉克索片	齐鲁制药（海南）有限公司	仿制药
17	海南	CYHS1700148	盐酸普拉克索片	齐鲁制药（海南）有限公司	仿制药
18	海南	CYHS1700149	盐酸普拉克索片	齐鲁制药（海南）有限公司	仿制药
19	海南	CYHS1700150	盐酸普拉克索片	齐鲁制药（海南）有限公司	仿制药
20	四川	CYHS1700119	阿哌沙班片	四川科伦药业股份有限公司	仿制药
21	云南	CXSS1700010	I型+III型口服脊髓灰质炎减毒活疫苗（人二倍体细胞）	中国医学科学院医学生物学研究所	新药
22	云南	CXSS1700011	I型+III型脊髓灰质炎减毒活疫苗糖丸（人二倍体细胞）	中国医学科学院医学生物学研究所	新药

　　Food and drug administration

September 12, 2017