Guidance on anonymization of protected personal data in RMPs

EMA’s latest guidance on anonymizing protected personal data (PPD) and assessing commercially confidential information (CCI) in Risk Management Plans (RMPs) provides key recommendations for maintaining data privacy and compliance. Key measures include omitting patient-level identifiers—such as subject IDs, dates of birth and death, and specific sensitive data—unless generalization is feasible. For company personnel data, only essential information, like the QPPV’s name, should remain. The guidance also urges applicants to proactively identify and propose the removal of CCI, particularly for details on studies within ongoing pediatric development plans (PIP), unless such information is publicly accessible.