皇冠体育在线_皇冠体育网-【官方网站】@

<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 300pt; LINE-HEIGHT: 150%; mso-char-indent-count: 25.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">国食药监安<SPAN lang=EN-US>[2012]106</SPAN>号 <SPAN lang=EN-US><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 0cm; LINE-HEIGHT: 150%; mso-char-indent-count: 0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">各省、自治区、直辖市食品药品监督管理局（药品监督管理局）：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">国家局《皇冠体育网:贯彻实施〈药品生产质量管理规范（<SPAN lang=EN-US>2010</SPAN>年修订）〉的通知》（国食药监安〔<SPAN lang=EN-US>2011</SPAN>〕<SPAN lang=EN-US>101</SPAN>号）规定：无菌药品的生产应在<SPAN lang=EN-US>2013</SPAN>年<SPAN lang=EN-US>12</SPAN>月<SPAN lang=EN-US>31</SPAN>日前达到新修订药品<SPAN lang=EN-US>GMP</SPAN>要求。无菌药品是指法定药品标准中列有无菌检查项目的药品，包括无菌制剂、无菌原料药。根据《中国药典（<SPAN lang=EN-US>2010</SPAN>版）》有关规定，考虑到眼用制剂的特殊性，特规定：眼内注射液<SPAN lang=EN-US>,</SPAN>眼内插入剂<SPAN lang=EN-US>,</SPAN>供手术、伤口、角膜穿透伤用的眼用制剂以及眼用液体制剂应在<SPAN lang=EN-US>2013</SPAN>年<SPAN lang=EN-US>12</SPAN>月<SPAN lang=EN-US>31</SPAN>日前达到新修订药品<SPAN lang=EN-US>GMP</SPAN>要求，其他眼用制剂应在<SPAN lang=EN-US>2015</SPAN>年<SPAN lang=EN-US>12</SPAN>月<SPAN lang=EN-US>31</SPAN>日前达到新修订药品<SPAN lang=EN-US>GMP</SPAN>要求。其他法定药品标准中列有无菌检查项目的所有制剂和原料药均应在<SPAN lang=EN-US>2013</SPAN>年<SPAN lang=EN-US>12</SPAN>月<SPAN lang=EN-US>31</SPAN>日前达到新修订的药品<SPAN lang=EN-US>GMP</SPAN>要求。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">按药品管理的体外诊断试剂应在<SPAN lang=EN-US>2015</SPAN>年<SPAN lang=EN-US>12</SPAN>月<SPAN lang=EN-US>31</SPAN>日前达到新修订药品<SPAN lang=EN-US>GMP</SPAN>要求。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">　各省局在以往办理无菌原料药、眼用制剂、体外诊断试剂的《药品<SPAN lang=EN-US>GMP</SPAN>证书》有效期延续工作中，如有与本通知要求不一致的地方，一律按本通知要求更正。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">　特此通知。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">　　　　　　　　　　　　　　　　　　　　　　　　　　　　国家食品药品监督管理局<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 12pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; COLOR: #565656; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; mso-bidi-font-family: Arial; mso-font-kerning: 18.0pt; mso-hansi-font-family: Arial">　　　　　　　　　　　　　　　　　　　　　　　　　　　　二○一二年四月二十日<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P>&nbsp;</P>