ICH = 2 Years after last approval based on study [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-09-01 09:03 (51 d 03:27 ago) – Posting: # 21906
Views: 902

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.


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