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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

序號	省份	受理號	藥品名稱	申報人	分類
1	/	JXHS1700030	磷酸特地唑胺片	拜耳醫藥保健有限公司	進口
2	/	JXHS1700031	注射用磷酸特地唑胺	拜耳醫藥保健有限公司	進口
3	/	JXHS1700033	吸入用鹽酸氨溴索溶液	韓美藥品株式會社；北京韓美藥品有限公司	進口
4	北京	CXSS1700012	23價肺炎球菌多糖疫苗	北京科興生物制品有限公司	新藥
5	北京	CXSS1700013	凍干b型流感嗜血桿菌結合疫苗	北京民海生物科技有限公司	新藥
6	吉林	CXSS1700015	流感病毒裂解疫苗（四價）	長春長生生物科技有限責任公司	新藥
7	江蘇	CYHS1700055	注射用替莫唑胺	江蘇恒瑞醫藥股份有限公司	仿制藥
8	江蘇	CYHS1700131	阿哌沙班片	正大天晴藥業集團股份有限公司	仿制藥
9	江蘇	CYHS1700138	安立生坦片	正大天晴藥業集團股份有限公司	仿制藥
10	安徽	CYHB1703734	富馬酸替諾福韋二吡呋酯片	安徽貝克生物制藥有限公司	補充申請
11	山東	CYHS1700189	鹽酸曲美他嗪緩釋片	齊魯制藥有限公司	仿制藥
12	湖北	CYHS1700136	氟比洛芬酯注射液	武漢大安制藥有限公司	仿制藥
13	廣東	CYHS1600219	替格瑞洛片	深圳信立泰藥業股份有限公司	仿制藥
14	廣東	CYHS1700112	頭孢呋辛酯片	深圳信立泰藥業股份有限公司	仿制藥
15	廣東	CYHS1700113	頭孢呋辛酯片	深圳信立泰藥業股份有限公司	仿制藥
16	海南	CYHS1700147	鹽酸普拉克索片	齊魯制藥（海南）有限公司	仿制藥
17	海南	CYHS1700148	鹽酸普拉克索片	齊魯制藥（海南）有限公司	仿制藥
18	海南	CYHS1700149	鹽酸普拉克索片	齊魯制藥（海南）有限公司	仿制藥
19	海南	CYHS1700150	鹽酸普拉克索片	齊魯制藥（海南）有限公司	仿制藥
20	四川	CYHS1700119	阿哌沙班片	四川科倫藥業股份有限公司	仿制藥
21	云南	CXSS1700010	I型+III型口服脊髓灰質炎減毒活疫苗（人二倍體細胞）	中國醫學科學院醫學生物學研究所	新藥
22	云南	CXSS1700011	I型+III型脊髓灰質炎減毒活疫苗糖丸（人二倍體細胞）	中國醫學科學院醫學生物學研究所	新藥

　　Food and drug administration

September 12, 2017