Sriramprasad
☆    

India,
2020-07-18 09:06
(761 d 13:02 ago)

Posting: # 21740
Views: 1,887
 

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

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 08:04
(738 d 14:03 ago)

@ Sriramprasad
Posting: # 21848
Views: 1,280
 

 Retention period and quantity for Malaysian submission

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 13:54
(670 d 08:13 ago)

@ cakhatri
Posting: # 22021
Views: 596
 

 Retention period and quantity for Malaysian submission

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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