Bioequivalence and Bioavailability Forum • Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?

Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? [Regulatives / Guidelines]

posted by Brus – Spain, 2020-09-01 11:06 (1555 d 14:37 ago) – Posting: # 21905
Views: 2,873

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

Complete thread:

Document Retention Period for Bioequivalence study Turkish Submission yatish gosai 2020-08-10 14:36 [Regulatives / Guidelines]
- Website of the Turkish Medicines and Medical Devices Agency Helmut 2020-08-10 15:15
- Document Retention Period for Bioequivalence study Turkish Submission Brus 2020-08-31 14:21
  - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Obinoscopy 2020-09-01 01:50
    - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?Brus 2020-09-01 09:06
      - ICH = 2 Years after last approval based on study Ohlbe 2020-09-01 11:03

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