yatish gosai
☆    

India,
2020-08-10 14:36
(44 d 13:19 ago)

Posting: # 21851
Views: 1,987
 

 Document Retention Period for Bioequivalence study Turkish Submission [Regulatives / Guidelines]

Dear Helmut,

I want to inquire the document retention period for BA-BE study (Turkish Submission).

Looking to have your response as always.
Helmut
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Vienna, Austria,
2020-08-10 15:15
(44 d 12:40 ago)

@ yatish gosai
Posting: # 21852
Views: 1,453
 

 Website of the Turkish Medicines and Medical Devices Agency

Hi Yatish,

I don’t have the slightest clue.
The English website is practically useless. Hire a translator and try to locate it at the Turkish one.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Brus
☆    

Spain,
2020-08-31 14:21
(23 d 13:34 ago)

@ yatish gosai
Posting: # 21902
Views: 866
 

 Document Retention Period for Bioequivalence study Turkish Submission

Dear Yatish gosai,

I have recently conducted a study in Turkey, and according to the Turkish agency's calendar, a maximum of 45 days is taken to issue approval.

Best regards,
Obinoscopy
★    

USA,
2020-09-01 01:50
(23 d 02:05 ago)

@ Brus
Posting: # 21904
Views: 849
 

 Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?

Dear Brus,

» I have recently conducted a study in Turkey, and according to the Turkish agency's calendar, a maximum of 45 days is taken to issue approval.

Thanks for this info.

Do you also know how long essential documents such as Case Report Forms (CRFs), Signed Protocols, Informed Consent Forms (ICFs), Ethics Committee Approval, etc. should be retained according to Turkey Regulatory Agency Guideline? I know it's 2 years for ICH and 5 years for Nigeria.

Regards,

Scopy
Brus
☆    

Spain,
2020-09-01 09:06
(22 d 18:49 ago)

@ Obinoscopy
Posting: # 21905
Views: 832
 

 Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?

Dear Obinoscopy,


2 Years for ICH? Where did you find that?

I do not know the requirement of the Turkish agency. For our clinical trial we have followed the EMA criteria since our dossier will be presented in European agencies.



The EMA's criteria regarding the TMF has been specified in a recent guideline. Retention time appears in section 6.3:

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf
Ohlbe
★★★

France,
2020-09-01 11:03
(22 d 16:52 ago)

@ Brus
Posting: # 21906
Views: 819
 

 ICH = 2 Years after last approval based on study

Dear Brus,

» 2 Years for ICH? Where did you find that?

In ICH E6 (GCP), § 4.9.5:

Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor.

Cave: not 2 years after the end of the study, but 2 years after the last approval based on that study.

Regards
Ohlbe
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