1 March, 2023

Guidance on anonymization of protected personal data in RMPs

Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6).

Patient-level information ‘is neither required nor expected’ in RMPs, the agency notes. If such information is part of case narratives or individual patient entries, companies should evaluate what to remove on a case-by-case basis, taking factors such as the type of medicinal product, indication and the size of the study into account (e.g., studies assessing rare diseases or information on genetic characteristics for small studies could lead to the identification of participants).

 

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