{"id":56179,"date":"2018-09-27T01:00:00","date_gmt":"2018-09-30T02:12:43","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e5%8c%97%e4%ba%ac-%e7%ac%ac%e4%ba%8c%e6%9c%9f2018%e5%9b%bd%e9%99%85%e5%8c%96%e6%b3%a8%e5%86%8c%e4%b8%93%e5%91%98%e6%8a%80%e8%83%bd%e6%8f%90%e5%8d%87%e4%b8%93%e9%a2%98%e5%9f%b9%e8%ae%ad\/"},"modified":"2018-09-30T10:12:44","modified_gmt":"2018-09-30T02:12:44","slug":"%e5%8c%97%e4%ba%ac-%e7%ac%ac%e4%ba%8c%e6%9c%9f2018%e5%9b%bd%e9%99%85%e5%8c%96%e6%b3%a8%e5%86%8c%e4%b8%93%e5%91%98%e6%8a%80%e8%83%bd%e6%8f%90%e5%8d%87%e4%b8%93%e9%a2%98%e5%9f%b9%e8%ae%ad","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/56179\/","title":{"rendered":"\u5317\u4eac-\u7b2c\u4e8c\u671f\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed"},"content":{"rendered":"
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1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-17:00<\/span><\/strong><\/p>\n

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  \u7b2c\u4e8c\u5929<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

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8:30-<\/span><\/strong>12:00<\/span><\/strong><\/p>\n

1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-1<\/span><\/strong>6<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n<\/td>\n

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2018<\/span><\/strong>\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u6700\u65b0\u653f\u7b56\u89e3\u8bfb<\/span><\/strong><\/p>\n

1.<\/span>\u6211\u56fd\u6700\u65b0\u836f\u54c1\u6ce8\u518c\u76f8\u5173\u6cd5\u89c4\u56fd\u9645\u5316\u8d8b\u52bf\u8bb2\u89e3<\/span><\/p>\n

a) <\/span>\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7<\/span>\u7cfb\u5217<\/span>\u653f\u7b56<\/span><\/p>\n

b) <\/span>\u65b0\u836f\u54c1\u6ce8\u518c\u5206\u7c7b\u7b80\u6790<\/span>\u53ca<\/span>\u5f02\u540c\u6bd4\u8f83<\/span><\/p>\n

c) \u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba<\/span>MAH\u7cfb\u5217<\/span>\u5236\u5ea6\u8ba8\u8bba<\/span><\/p>\n

d) <\/span>\u539f<\/span>\u8f85<\/span>\u5305\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279<\/span>\u7cfb\u5217<\/span>\u653f\u7b56\u8ba8\u8bba<\/span><\/p>\n

2.\u672a\u6765\u6cd5\u89c4\u5411ICH\u7684\u53d8\u5316\u8d8b\u52bf<\/span><\/p>\n

FDA<\/span>\u548c\u6b27\u76df\u6ce8\u518c\u6cd5\u89c4\u548c\u6d41\u7a0b\u4ecb\u7ecd<\/span>\u4ee5<\/span>\u53ca<\/span>\u672a\u6765<\/span>\u6211\u56fd\u7684\u501f\u9274<\/span>  \u4e34\u5e8a\u5907\u6848\u5236<\/span><\/p>\n

\u6ce8\u518c\u7533\u62a5\u8fc7\u7a0b\u5e38\u89c1\u5173\u952e\u95ee\u9898<\/span><\/strong><\/p>\n

1.<\/span>\u8d44\u6599\u641c\u96c6\u64b0\u5199\u4e2d\u7684\u5e38\u89c1\u95ee\u9898<\/span><\/p>\n

\u6570\u636e\u5b8c\u6574\u6027\u786e\u4fdd<\/span>  <\/span>\u4fdd\u969c\u65f6\u95f4\u8fdb\u5ea6\u53ca\u8d44\u6599\u8d28\u91cf<\/span><\/p>\n

2.<\/span>\u836f\u54c1\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u7684\u8981\u70b9\u53ca\u7f3a\u9677\u5206\u6790<\/span><\/p>\n

\u8fd1\u671f\u56fd\u5185\u5916\u4e0d\u5408\u683c\u9879\u76ee\u6c47\u603b\u5206\u6790<\/span><\/p>\n

3.<\/span>\u4e00\u81f4\u6027\u8bc4\u4ef7\/<\/span>\u5173\u8054\u5ba1\u8bc4<\/span>\/<\/span>\u518d\u6ce8\u518c\u4e2d\u6613\u5ffd\u7565\u7684\u95ee\u9898<\/span><\/span><\/p>\n

\u73b0\u573a\u8ba8\u8bba\u4e92\u52a8<\/span><\/strong><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a\u9648\u535a\u58eb,\u56fd\u5185\u9f99\u5934\u836f\u4f01\u7814\u7a76\u9662\u836f\u7269\u7814\u53d1\u526f\u9662\u957f,\u9886\u5bfc\u548c\u7ba1\u7406\u836f\u7269\u5408\u6210\uff0c\u5236\u5242\u5f00\u53d1\uff0c\u5206\u6790\u7814\u53d1\u548cANDA\u7533\u62a5\u5168\u8fc7\u7a0b\uff1b\u62e5\u670923\u5e74\u5728\u7f8e\u56fdAdolor\u963f\u9053\u7f57\u5236\u836f\uff0c\u7f8e\u56fdJ&J\u5f3a\u751f\u5236\u836f\uff0c\u7f8e\u56fdTeva\u68af\u74e6\u548cNexgen\u5236\u836f\u516c\u53f8\u7b49\u5de5\u4f5c\u7ecf\u9a8c\u3002\u66fe\u5728\u7f8e\u56fd\u9886\u5bfc\u548c\u7ba1\u7406\u4e00\u4e2a\u670911\u4e2a\u804c\u80fd\u56e2\u961f\u7684GMP\u7814\u53d1\u90e8\u652f\u6301\u516c\u53f8\u7684\u4eff\u5236\u836f\uff08Generic Drug\uff09\u836f\u7269\u7814\u53d1.\u672c\u534f\u4f1a\u7279\u9080\u8bb2\u5e08\u3002<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n
\n

\"\u5317\u4eac-\u7b2c\u4e8c\u671f\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed\"\u70b9\u51fb\u4e0b\u56fe\u4e8c\u7ef4\u7801\u5373\u53ef\u62a5\u540d\u6ce8\u518c<\/span><\/strong><\/span>
<\/p>\n


<\/span><\/strong><\/p>\n<\/section>\n

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\n
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<\/section>\n
<\/span>        <\/span>       <\/span>      <\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u9488\u5bf9\u672c\u6b21\u57f9\u8bad\u4e13\u9898\u5185\u5bb9\uff0c\u7ed3\u5408\u5b9e\u9645\u5de5\u4f5c\u4e2d\u9047\u5230\u54ea\u4e9b\u95ee\u9898\uff1f\u4ee5\u4fbf\u6211\u4eec\u53cd\u9988\u7ed9\u8001\u5e08\u5e76\u5230\u4f1a\u573a\u4ea4\u6d41\u63a2\u8ba8\u3001\u7b54\u7591\u89e3\u60d1\u3002<\/span><\/strong><\/span>
<\/p>\n

\u95ee\u98981\u3001<\/span>                                           <\/span><\/span><\/p>\n

\u95ee\u98982\u3001<\/span>                                           <\/span><\/span><\/p>\n


<\/p>\n


<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u5173\u4e8e\u4e3e\u529e\u7b2c\u4e8c\u671f\u201c2018\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5 \u5404\u6709\u5173\u5355\u4f4d \u81f3\u4ece2017\u5e74\u4e2d\u56fd\u6b63\u5f0f\u52a0\u5165\u4e86IC […]<\/p>\n","protected":false},"author":1,"featured_media":56180,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/56179"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=56179"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/56179\/revisions"}],"predecessor-version":[{"id":56184,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/56179\/revisions\/56184"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/56180"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=56179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=56179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=56179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}