
19/08/2025
๐ถ๏ธ๐ ๐ฎ๐๐ธ๐ถ๐ป๐ด ๐ฝ๐ฒ๐ฟ๐๐ผ๐ป๐ฎ๐น ๐ฑ๐ฎ๐๐ฎ ๐ถ๐ป ๐ฝ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ผ๐๐ถ๐ด๐ถ๐น๐ฎ๐ป๐ฐ๐ฒ: ๐ฝ๐ฟ๐ถ๐๐ฎ๐ฐ๐ ๐๐. ๐ฝ๐ฎ๐๐ถ๐ฒ๐ป๐ ๐๐ฎ๐ณ๐ฒ๐๐
Not all details in ICSRs should be visible - and not all should be hidden.
Since July 2025, the ๐ช๐บEMA has enforced new rules on handling personal data in ICSRs. Some fields must be masked, some left blank, and others remain visible - because patient safety depends on it.
๐กThe new EMA guidance on masking of personal data in pharmacovigilance changes the way we balance data protection with drug safety.
๐ Read our latest DrugCard blog to learn what MAHs and PV specialists must know: https://drug-card.io/blog/masking-of-personal-data-in-pharmacovigilance/