Sriramprasad
☆    

India,
2020-07-18 11:06
(1810 d 15:44 ago)

Posting: # 21740
Views: 3,435
 

 Retention period and quantity for Malaysian submission [Regulatives / Guidelines]

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Dear All,

Greetings!!..

May i know the retention period and number of samples for Malaysian submission.

I have reviewed ASEAN GUIDELINES and not found any relevant information.

And also, Can we prepare Clinical study report according to ICH-E3 guidelines for Malaysian submission.

Thanks in advance

Regards,
Sriram
 
cakhatri
★    

India,
2020-08-10 10:04
(1787 d 16:45 ago)

@ Sriramprasad
Posting: # 21848
Views: 2,559
 

 Retention period and quantity for Malaysian submission

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Dear Sriram,

Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf

You can refer section 4.1

The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site

Regards
Chirag
 
Sriramprasad
☆    

India,
2020-10-17 15:54
(1719 d 10:55 ago)

@ cakhatri
Posting: # 22021
Views: 1,821
 

 Retention period and quantity for Malaysian submission

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Dear Chirag,

Thank you for your replay.

Regards,
Sriram

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
 
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