Jul 16, 2016 13:15
7 yrs ago
1 viewer *
English term
Prior Approval Supplement (PAS)
English to Chinese
Medical
Medical: Pharmaceuticals
Assay approval for a vaccine
I am not sure, but I think 批准后方可实施, 需事先批准的补充申请, 先前批准补充申请, 批准前的补充申请are not accurate.
As I know, Post Approval Changes means 上市后变更.
As I know, Post Approval Changes means 上市后变更.
Proposed translations
(Chinese)
| 4 +2 | 对于先前的批准的补充 |
jyuan_us
|
| 4 +1 | 批准前申报/批准前申请补充 |
pkchan
|
| 3 | 预先批准所需之补充材料 |
Bruce Guo
|
Proposed translations
+2
15 hrs
Selected
对于先前的批准的补充
这样断句：“prior approval” + supplement= prior approval‘s supplement = A supplement TO A prior approval = 对于先前的批准的补充
也就是在有新资料出现时向FDA提交补充件
--------------------------------------------------
Note added at 16 hrs (2016-07-17 05:31:26 GMT)
--------------------------------------------------
网上的去许多译文（包括大药商的译文）的错误都是由于译者把PRIOR等同于PRE.两者看似类似，意思差之千里。 PRIOR = Previous, not = Before something
也就是在有新资料出现时向FDA提交补充件
--------------------------------------------------
Note added at 16 hrs (2016-07-17 05:31:26 GMT)
--------------------------------------------------
网上的去许多译文（包括大药商的译文）的错误都是由于译者把PRIOR等同于PRE.两者看似类似，意思差之千里。 PRIOR = Previous, not = Before something
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
+1
1 hr
批准前申报/批准前申请补充
FDA公布已批准变更的可比性方案应用指南草案 - 360Doc个人图书馆
www.360doc.com/content/16/0508/06/723238_557181313.shtml
Translate this page
May 8, 2016 - ... application or prior approval supplement (PAS) will, in many cases, ... 在原始申报或批准前申报（PAS）中使用CP，在许多情形下，会有助于之后 ...
FDA行业指南 201403：应在年报中记载的CMC已批准生产变更（一）_ ...
blog.sina.com.cn/s/blog_4298a2c80101hzmo.html
Translate this page
Jun 6, 2014 - 附录B提供了在年报中应记载的轻微变更的例子，之前是包括在FDA的放大 ... is distributed (also known as a prior approval supplement (PAS)).
生命科学与制药博客| 汤森路透
ip-science.thomsonreuters.com.cn/lscn/ls-blog/20160403.shtml
Translate this page
Apr 3, 2016 - 美国卫生与公共服务部（U.S. Health and Human Services，HHS）前 .... 年，之前批准申请的补充（Prior Approval Supplements，PAS）和CR的数量 ...
www.360doc.com/content/16/0508/06/723238_557181313.shtml
Translate this page
May 8, 2016 - ... application or prior approval supplement (PAS) will, in many cases, ... 在原始申报或批准前申报（PAS）中使用CP，在许多情形下，会有助于之后 ...
FDA行业指南 201403：应在年报中记载的CMC已批准生产变更（一）_ ...
blog.sina.com.cn/s/blog_4298a2c80101hzmo.html
Translate this page
Jun 6, 2014 - 附录B提供了在年报中应记载的轻微变更的例子，之前是包括在FDA的放大 ... is distributed (also known as a prior approval supplement (PAS)).
生命科学与制药博客| 汤森路透
ip-science.thomsonreuters.com.cn/lscn/ls-blog/20160403.shtml
Translate this page
Apr 3, 2016 - 美国卫生与公共服务部（U.S. Health and Human Services，HHS）前 .... 年，之前批准申请的补充（Prior Approval Supplements，PAS）和CR的数量 ...
12 days
预先批准所需之补充材料
FYI
Something went wrong...