ICH-GCP
Section 4.9.5 (Archiving duration)
Essential documents must be conserved for:
at least 2 years following the last approval of the authorisation request for product marketing authorisation (AIC) and until there are no pending or contemplated marketing applications or until 2 years have elapsed from the formal interruption of the clinical development of the study drug; they must be conserved for a longer period if requested by applicable regulatory provisions or by agreement with the sponsor.
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