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
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序號(hào)
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省份
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受理號(hào)
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藥品名稱
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申報(bào)人
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分類
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1
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/
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JXHS1700030
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磷酸特地唑胺片
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拜耳醫(yī)藥保健有限公司
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進(jìn)口
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2
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/
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JXHS1700031
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注射用磷酸特地唑胺
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拜耳醫(yī)藥保健有限公司
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進(jìn)口
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3
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/
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JXHS1700033
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吸入用鹽酸氨溴索溶液
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韓美藥品株式會(huì)社；北京韓美藥品有限公司
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進(jìn)口
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4
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北京
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CXSS1700012
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23價(jià)肺炎球菌多糖疫苗
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北京科興生物制品有限公司
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新藥
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5
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北京
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CXSS1700013
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凍干b型流感嗜血桿菌結(jié)合疫苗
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北京民海生物科技有限公司
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新藥
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6
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吉林
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CXSS1700015
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流感病毒裂解疫苗（四價(jià)）
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長(zhǎng)春長(zhǎng)生生物科技有限責(zé)任公司
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新藥
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7
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江蘇
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CYHS1700055
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注射用替莫唑胺
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江蘇恒瑞醫(yī)藥股份有限公司
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仿制藥
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8
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江蘇
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CYHS1700131
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阿哌沙班片
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正大天晴藥業(yè)集團(tuán)股份有限公司
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仿制藥
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9
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江蘇
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CYHS1700138
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安立生坦片
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正大天晴藥業(yè)集團(tuán)股份有限公司
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仿制藥
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10
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安徽
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CYHB1703734
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富馬酸替諾福韋二吡呋酯片
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安徽貝克生物制藥有限公司
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補(bǔ)充申請(qǐng)
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11
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山東
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CYHS1700189
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鹽酸曲美他嗪緩釋片
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齊魯制藥有限公司
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仿制藥
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12
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湖北
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CYHS1700136
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氟比洛芬酯注射液
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武漢大安制藥有限公司
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仿制藥
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13
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廣東
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CYHS1600219
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替格瑞洛片
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深圳信立泰藥業(yè)股份有限公司
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仿制藥
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14
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廣東
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CYHS1700112
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頭孢呋辛酯片
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深圳信立泰藥業(yè)股份有限公司
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仿制藥
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15
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廣東
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CYHS1700113
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頭孢呋辛酯片
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深圳信立泰藥業(yè)股份有限公司
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仿制藥
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16
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海南
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CYHS1700147
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鹽酸普拉克索片
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齊魯制藥（海南）有限公司
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仿制藥
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17
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海南
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CYHS1700148
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鹽酸普拉克索片
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齊魯制藥（海南）有限公司
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仿制藥
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18
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海南
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CYHS1700149
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鹽酸普拉克索片
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齊魯制藥（海南）有限公司
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仿制藥
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19
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海南
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CYHS1700150
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鹽酸普拉克索片
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齊魯制藥（海南）有限公司
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仿制藥
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20
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四川
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CYHS1700119
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阿哌沙班片
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四川科倫藥業(yè)股份有限公司
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仿制藥
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21
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云南
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CXSS1700010
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I型+III型口服脊髓灰質(zhì)炎減毒活疫苗（人二倍體細(xì)胞）
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中國(guó)醫(yī)學(xué)科學(xué)院醫(yī)學(xué)生物學(xué)研究所
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新藥
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22
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云南
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CXSS1700011
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I型+III型脊髓灰質(zhì)炎減毒活疫苗糖丸（人二倍體細(xì)胞）
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中國(guó)醫(yī)學(xué)科學(xué)院醫(yī)學(xué)生物學(xué)研究所
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新藥
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Food and drug administration
September 12, 2017
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