Prior Approval Supplement (PAS)

Chinese translation: 对于先前的批准的补充

13:15 Jul 16, 2016
English to Chinese translations [PRO]
Medical - Medical: Pharmaceuticals / Assay approval for a vaccine
English term or phrase: Prior Approval Supplement (PAS)
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.
Julia_Z
China
Local time: 13:22
Chinese translation:对于先前的批准的补充
Explanation:
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

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Note added at 16 hrs (2016-07-17 05:31:26 GMT)
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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
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jyuan_us
United States
Local time: 01:22
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
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


  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
prior approval supplement (pas)
批准前申报/批准前申请补充


Explanation:
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 ...

pkchan
United States
Local time: 01:22
Native speaker of: Native in ChineseChinese
PRO pts in category: 24

Peer comments on this answer (and responses from the answerer)
agree  Fubin Che
7 days
Login to enter a peer comment (or grade)

15 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
prior approval supplement (pas)
对于先前的批准的补充


Explanation:
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

jyuan_us
United States
Local time: 01:22
Specializes in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 182
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  tanglsus
9 hrs

agree  Fubin Che
42 days
Login to enter a peer comment (or grade)

12 days   confidence: Answerer confidence 3/5Answerer confidence 3/5
prior approval supplement (pas)
预先批准所需之补充材料


Explanation:
FYI

Bruce Guo
China
Local time: 08:22
Native speaker of: Native in ChineseChinese, Native in EnglishEnglish
Login to enter a peer comment (or grade)



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