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height: 356px;" /></span><br />  </p> <p> <span style="font-size:14px;">  “办法”提出,药品标准包括国家药品标准、地方药品标准和药品注册标准。其中,国家药品标准包括“中国药典”和国家药品监督管理部门颁布的其他药品标准,而国家药品监督管理部门颁布的其他药品标准和药品注册标准应当符å?ldquo;中国药典”的有关通用技术要求ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  “办法”规定,国家药典委员会负责国家<a href="http://www.chinatesting.com.cn/0hyzx/b/20170816839.html"><span style="color:#0000cd;">药品</span></a>标准的制定和修订,并对相关通用技术进行统一规定,包括:药品的通用名称和专业技术术è¯?药品标准编制体例及内容的技术要æ±?药品标准物质的相关技术要求等ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  此外ï¼?ldquo;中国药典”收载的品种应当为临床常用、疗效确切、使用安全、工艺成熟、质量可控的药品ã€?ldquo;中国药典”收载标准经修订后,有关内容载入新ç‰?ldquo;中国药典”或其增补本ã€?ldquo;中国药典”将每5年颁布一版ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  “办法”还要求,国家药品标准的制定与修订,应当按照起草、审核、公示等环节进行。如遇药品安全等重大突发事件,可根据需要启动国家药品标准的制定或修订工作,并按照有关规定加快开展。此外,国家药品标准和《中国药品目录集》收载品种的药品标准应及时向社会公开ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  国家药品标准自实施之日起,药品的生产、经营、使用、监督及检验等活动均应当严格执行。不符合国家药品标准的药品,不得生产、销售和使用,如有特殊情况,可给äº?个月的标准执行过渡期ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  è€?ldquo;中国药典”颁布后,药品上市许可持有äº?药品生产企业)应当及时审查其药品注册标准的适用性。对于药品注册标准与“中国药典”的有关要求不符的、检验项目少于或质量指标低于“中国药典”规定的,药品上市许可持有äº?药品生产企业)应当按照《药品注册管理办法》的规定进行修订或执è¡?ldquo;中国药典”。对于药品注册标准收载的检验项目多äº?包括异于)或质量指标严äº?ldquo;中国药典”规定的,药品上市许可持有äº?药品生产企业)应在执行“中国药典”规定的基础上,同时执行药品注册标准的相应项目和指标。同时,药品上市许可持有äº?药品生产企业)应当根据有关规定,在药品说明书、标签上标注所执行的药品标准ã€?/span></p> <p> <span style="font-size:14px;">  </span></p> <p> <span style="font-size:14px;">  另外,国家还鼓励将科学先进、经济适用的技术方法应用于药品标准;鼓励药品上市许可持有äº?药品生产企业)不断完善药品标准;鼓励企业和社团组织或个人参与药品标准工作,提出合理意见和建议;鼓励开展药品标准的国际交流与合作,积极参与药品标准的国际协调ã€?/span></p> <hr /> <p> <span style="font-size: 14px;">  </span><span style="font-size:14px;">相关文章ï¼?a href="http://www.chinatesting.com.cn/0hyzx/b/20170816667.html"><span style="color:#0000cd;">食药总局:《食品药品行政处罚案件信息公开实施细则(征求意见稿)ã€?/span></a></span></p> </div> <ul class="zxmainpage"></ul> <p class="zxmainlkey">关键词:国务院法制办,药品标准,中国药典</p> <p class="zxmainlfen"><div class="bshare-custom">分享到:<a title="分享到QQ空间" class="bshare-qzone"></a><a title="分享到新浪微å? class="bshare-sinaminiblog"></a><a title="分享到人人网" class="bshare-renren"></a><a title="分享到腾讯微å? class="bshare-qqmb"></a><a title="分享到网易微å? class="bshare-neteasemb"></a><a title="更多平台" class="bshare-more bshare-more-icon more-style-addthis"></a><span class="BSHARE_COUNT bshare-share-count">0</span></div><script type="text/javascript" charset="utf-8" src="http://static.bshare.cn/b/buttonLite.js#style=-1&uuid=&pophcol=2&lang=zh"></script><script type="text/javascript" charset="utf-8" src="http://static.bshare.cn/b/bshareC0.js"></script></p> <p class="zxmainlxia">下一篇:<a href='/0zcgf/b/20171217667.html'>你还在用吗?CFDA已停用药品注册受理专用章</a> </p> <p class="zxmainlshang">上一篇:<a href='/0zcgf/b/20171217629.html'>两部委|适时将石化产业绿色产品评价标准纳入绿色产品评价标准清å?/a> </p> <div class="zxmainlbar"><a href="../../guanggao.html" target="_blank"><img src="/uploads/allimg/141121/1_1130244451.GIF" border="0" /></a></div> <div class="zxmainlxgpl"> <!-- //主模板必须要引入/include/dedeajax2.js --> <a name='postform'></a> <div class="mt1"> <dl class="tbox"> <dt> <strong>发表评论</strong> <span class="more"></span> </dt> <dd> <div class="dede_comment_post"> <form action="#" method="post" name="feedback" onsubmit="return false;"> <input type="hidden" name="dopost" value="send" /> <input type="hidden" name="comtype" value="comments"> <input type="hidden" name="aid" value="17661" /> <input type="hidden" name="fid" id='feedbackfid' value="0" /> <!-- /dcmp-title --> <div class="dcmp-stand"> <strong>评价:</strong> <input type="radio" name="feedbacktype" checked="1" value="feedback" id="dcmp-stand-neu" /> <label for="dcmp-stand-neu"><img src="/templets/html/images/cmt-neu.gif" />中立</label> <input type="radio" name="feedbacktype" value="good" id="dcmp-stand-good" /> <label for="dcmp-stand-good"><img src="/templets/html/images/cmt-good.gif" />好评</label> <input type="radio" name="feedbacktype" value="bad" id="dcmp-stand-bad" /> <label for="dcmp-stand-bad"><img src="/templets/html/images/cmt-bad.gif" />差评</label> </div> <!-- /dcmp-stand --> <div class="clr"></div> <div class="dcmp-content"> <script type="text/javascript"> //<![CDATA[ window.CKEDITOR_BASEPATH='/include/ckeditor/'; 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var waithtml = "<div style='line-height:50px'><img src='/images/loadinglit.gif' />评论加载ä¸?..</div>"; var myajax = new DedeAjax(taget_obj, true, true, '', 'x', waithtml); myajax.SendGet2("/plus/feedback_ajax.php?dopost=getlist&aid=17661&page="+page); DedeXHTTP = null; } function PostComment() { var f = document.feedback; var msg = CKEDITOR.instances.msg.getData(); var nface = '6'; var nfeedbacktype = 'feedback'; var nvalidate = ''; var nnotuser = ''; var nusername = ''; var npwd = ''; var taget_obj = $DE('commetcontentNew'); var waithtml = "<div style='line-height:30px'><img src='/images/loadinglit.gif' />正在发送中...</div>"; if(msg=='') { alert("评论内容不能为空ï¼?); return; } if(f.validate) { if(f.validate.value=='') { alert("请填写验证码ï¼?); return; } else { nvalidate = f.validate.value; } } if(msg.length > 500) { alert("你的评论是不是太长了?请填写500字以内的评论ã€?); return; } if(f.feedbacktype) { for(var i=0; i < f.feedbacktype.length; i++) if(f.feedbacktype[i].checked) nfeedbacktype = f.feedbacktype[i].value; } /* if(f.face) { for(var j=0; j < f.face.length; j++) if(f.face[j].checked) nface = f.face[j].value; } */ if(f.notuser.checked) nnotuser = '1'; if(f.username) nusername = f.username.value; if(f.pwd) npwd = f.pwd.value; var myajax = new DedeAjax(taget_obj, false, true, '', '', waithtml); myajax.sendlang = 'utf-8'; myajax.AddKeyN('dopost', 'send'); myajax.AddKeyN('aid', '17661'); myajax.AddKeyN('fid', f.fid.value); myajax.AddKeyN('face', nface); myajax.AddKeyN('feedbacktype', nfeedbacktype); myajax.AddKeyN('validate', nvalidate); myajax.AddKeyN('notuser', nnotuser); myajax.AddKeyN('username', nusername); myajax.AddKeyN('pwd', npwd); myajax.AddKeyN('msg', msg); myajax.SendPost2('/plus/feedback_ajax.php'); //msg = ''; CKEDITOR.instances.msg.setData(''); //taget_obj.removeAttribute('id'); f.fid.value = 0; if(f.validate) { if($DE('validateimg')) $DE('validateimg').src = "/include/vdimgck.php?"+f.validate.value; f.validate.value = ''; } } function quoteCommet(fid) { document.feedback.fid.value = fid; } function ajaxFeedback(aid, fid, type) { var taget_obj = $DE('ajaxfeedback_'+fid); if(taget_obj.innerHTML == '') { var myajax = new DedeAjax(taget_obj, true, true, '', 'x'); myajax.SendGet2("/plus/feedback.php?aid="+aid+"&fid="+fid+"&action=quote&type=ajax"); eval('var result = typeof CKEDITOR.instances.msg_'+fid); if(result != 'undefined') { // 删除实例 eval('var edit = CKEDITOR.instances.msg_'+fid); CKEDITOR.remove(edit); } CKEDITOR.replace(document.getElementById('msg_'+fid) , CKEDITOR.instances.msg.config); scroll(0, taget_obj.offsetTop - 120); var formname = 'f = document.ajaxfeedback_'+fid; eval(formname); if(f.validate) { if($DE('vdimg_'+fid)) $DE('vdimg_'+fid).src = "/include/vdimgck.php?"+f.validate.value; f.validate.value = ''; } DedeXHTTP = null; } } function ajaxQuotePost(fid) { var formname = 'f = document.ajaxfeedback_'+fid; eval(formname); //var f = document.formname; //var f = f[0]; var nvalidate = ''; var nnotuser = ''; var nusername = ''; var npwd = ''; var taget_obj = $DE('commetcontentNew'); var waithtml = "<div style='line-height:30px'><img src='/images/loadinglit.gif' />正在发送中...</div>"; eval('var msg = CKEDITOR.instances.msg_'+fid+'.getData()'); if(f.validate) { if(f.validate.value=='') { alert("请填写验证码ï¼?); return; } else { nvalidate = f.validate.value; } } var myajax = new DedeAjax(taget_obj, false, true, '', '', waithtml); if(f.notuser.checked) nnotuser = '1'; if(f.username) nusername = f.username.value; if(f.pwd) npwd = f.pwd.value; myajax.sendlang = 'utf-8'; myajax.AddKeyN('dopost', 'send'); myajax.AddKeyN('aid', '17661'); myajax.AddKeyN('fid', f.fid.value); myajax.AddKeyN('type', 'ajax'); myajax.AddKeyN('comtype', f.comtype.value); myajax.AddKeyN('isconfirm','yes'); myajax.AddKeyN('typeid', f.typeid.value); myajax.AddKeyN('quotemsg', f.quotemsg.value); myajax.AddKeyN('validate', nvalidate); myajax.AddKeyN('notuser', nnotuser); myajax.AddKeyN('username', nusername); myajax.AddKeyN('pwd', npwd); myajax.AddKeyN('msg', msg); myajax.SendPost2('/plus/feedback_ajax.php'); //alert(f.quotemsg.value); if($DE('ajaxfeedback_'+fid).innerHTML != null) { $DE('ajaxfeedback_'+fid).innerHTML = ''; 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var waithtml = "<div style='line-height:50px'><img src='/images/loadinglit.gif' />评论加载ä¸?..</div>"; var myajax = new DedeAjax(taget_obj, true, true, '', 'x', waithtml); myajax.SendGet2("/plus/feedback_ajax.php?dopost=getlist&aid=17661&page="+page); DedeXHTTP = null; } function PostComment() { var f = document.feedback; var msg = CKEDITOR.instances.msg.getData(); var nface = '6'; var nfeedbacktype = 'feedback'; var nvalidate = ''; var nnotuser = ''; var nusername = ''; var npwd = ''; var taget_obj = $DE('commetcontentNew'); var waithtml = "<div style='line-height:30px'><img src='/images/loadinglit.gif' />正在发送中...</div>"; if(msg=='') { alert("评论内容不能为空ï¼?); return; } if(f.validate) { if(f.validate.value=='') { alert("请填写验证码ï¼?); return; } else { nvalidate = f.validate.value; } } if(msg.length > 500) { alert("你的评论是不是太长了?请填写500字以内的评论ã€?); return; } if(f.feedbacktype) { for(var i=0; i < f.feedbacktype.length; i++) if(f.feedbacktype[i].checked) nfeedbacktype = f.feedbacktype[i].value; } /* if(f.face) { for(var j=0; j < f.face.length; j++) if(f.face[j].checked) nface = f.face[j].value; } */ if(f.notuser.checked) nnotuser = '1'; if(f.username) nusername = f.username.value; if(f.pwd) npwd = f.pwd.value; var myajax = new DedeAjax(taget_obj, false, true, '', '', waithtml); myajax.sendlang = 'utf-8'; myajax.AddKeyN('dopost', 'send'); myajax.AddKeyN('aid', '17661'); myajax.AddKeyN('fid', f.fid.value); myajax.AddKeyN('face', nface); myajax.AddKeyN('feedbacktype', nfeedbacktype); myajax.AddKeyN('validate', nvalidate); myajax.AddKeyN('notuser', nnotuser); myajax.AddKeyN('username', nusername); myajax.AddKeyN('pwd', npwd); myajax.AddKeyN('msg', msg); myajax.SendPost2('/plus/feedback_ajax.php'); //msg = ''; CKEDITOR.instances.msg.setData(''); //taget_obj.removeAttribute('id'); f.fid.value = 0; if(f.validate) { if($DE('validateimg')) $DE('validateimg').src = "/include/vdimgck.php?"+f.validate.value; f.validate.value = ''; } } function quoteCommet(fid) { document.feedback.fid.value = fid; } function ajaxFeedback(aid, fid, type) { var taget_obj = $DE('ajaxfeedback_'+fid); if(taget_obj.innerHTML == '') { var myajax = new DedeAjax(taget_obj, true, true, '', 'x'); myajax.SendGet2("/plus/feedback.php?aid="+aid+"&fid="+fid+"&action=quote&type=ajax"); eval('var result = typeof CKEDITOR.instances.msg_'+fid); if(result != 'undefined') { // 删除实例 eval('var edit = CKEDITOR.instances.msg_'+fid); CKEDITOR.remove(edit); } CKEDITOR.replace(document.getElementById('msg_'+fid) , CKEDITOR.instances.msg.config); scroll(0, taget_obj.offsetTop - 120); var formname = 'f = document.ajaxfeedback_'+fid; eval(formname); if(f.validate) { if($DE('vdimg_'+fid)) $DE('vdimg_'+fid).src = "/include/vdimgck.php?"+f.validate.value; f.validate.value = ''; } DedeXHTTP = null; } } function ajaxQuotePost(fid) { var formname = 'f = document.ajaxfeedback_'+fid; eval(formname); //var f = document.formname; //var f = f[0]; var nvalidate = ''; var nnotuser = ''; var nusername = ''; var npwd = ''; var taget_obj = $DE('commetcontentNew'); var waithtml = "<div style='line-height:30px'><img src='/images/loadinglit.gif' />正在发送中...</div>"; eval('var msg = CKEDITOR.instances.msg_'+fid+'.getData()'); if(f.validate) { if(f.validate.value=='') { alert("请填写验证码ï¼?); return; } else { nvalidate = f.validate.value; } } var myajax = new DedeAjax(taget_obj, false, true, '', '', waithtml); if(f.notuser.checked) nnotuser = '1'; if(f.username) nusername = f.username.value; if(f.pwd) npwd = f.pwd.value; myajax.sendlang = 'utf-8'; myajax.AddKeyN('dopost', 'send'); myajax.AddKeyN('aid', '17661'); myajax.AddKeyN('fid', f.fid.value); myajax.AddKeyN('type', 'ajax'); myajax.AddKeyN('comtype', f.comtype.value); myajax.AddKeyN('isconfirm','yes'); myajax.AddKeyN('typeid', f.typeid.value); myajax.AddKeyN('quotemsg', f.quotemsg.value); myajax.AddKeyN('validate', nvalidate); myajax.AddKeyN('notuser', nnotuser); myajax.AddKeyN('username', nusername); myajax.AddKeyN('pwd', npwd); myajax.AddKeyN('msg', msg); myajax.SendPost2('/plus/feedback_ajax.php'); //alert(f.quotemsg.value); if($DE('ajaxfeedback_'+fid).innerHTML != null) { $DE('ajaxfeedback_'+fid).innerHTML = ''; 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