乐彩网17500:进一步明确眼用制剂等产品实施新修订药品GMP期限的通知
发布时间:2012年04月26日 来源:乐彩网17500 分享:
<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《乐彩网17500: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> </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>
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