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

posted by Ohlbe – France, 2020-09-01 11:03 (177 d 04:28 ago) – Posting: # 21906
Views: 1,075

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.


Complete thread:

 Admin contact
21,356 posts in 4,458 threads, 1,493 registered users;
online 4 (1 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 14:31 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz