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乐彩网17500:进一步规范原料药混合粉注册管理的通知
发布时间:2012年01月12日      来源:乐彩网17500      分享:
<P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">各省、自治区、直辖市食品药品监督管理局(药品监督管理局),总后卫生部药品监督管理局:</SPAN><SPAN lang=EN-US style="FONT-SIZE: 14pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">为进一步规范原料药混合粉注册管理,保证产品质量,现就制剂用原料药混合粉注册管理有关要求通知如下:<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">一、原料药混合粉生产企业必须持有混合粉所需原料药的批准文号并通过<SPAN lang=EN-US>GMP</SPAN>认证,混合粉生产过程应通过药品<SPAN lang=EN-US>GMP</SPAN>现场检查。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">二、使用混合粉的制剂生产企业对原料药混合粉生产企业进行供应商审计后,按照《药品注册管理办法》的规定,提出“改变影响药品质量的生产工艺”补充申请,并提交混合粉相关研究资料和供应商审计资料,经批准后方可使用。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN lang=EN-US style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><o:p>&nbsp;</o:p></SPAN></P> <P class=MsoNormal style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN lang=EN-US style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">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: 23.05pt; LINE-HEIGHT: 150%; mso-char-indent-count: 1.92"><SPAN lang=EN-US style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN><SPAN style="mso-spacerun: yes">&nbsp;</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">二○一一年十二月三十日<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P> <P>&nbsp;</P>
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