Anonymization of Protected Personal Data and Assessment of Commercially Confidential Information during the Preparation of RMPs

4 November 2022 – EMA updated RMP guidance (main body and annexes 4 & 6) for protected personal data and confidential information.

This document aims at giving general guidance to companies on the retention/removal of Protected Personal Data (PPD) and identification of Commercially Confidential Information (CCI). All the changes suggested in this guidance are of editorial nature and should be implemented in the RMP during the scientific review process prior to the Opinion and adoption of the final RMP version.

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