Clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified, in order to comply with European legislation on personal data protection. This usually involves redacting personal data; the redaction appears as a light blue box with a black 'PPD' label. EMA publishes the applicant's anonymisation report, which describes the anonymisation methods they used and their impact on data utility.

Companies must also justify the redaction of any commercially confidential information (CCI).

The Agency considers that, in general, clinical data cannot be considered CCI but in limited circumstances study reports may contain CCI, which can be redacted. The redaction appears as a black box with a red 'CCI' label.

EMA reviews the company's redaction proposal and provides recommendations. The company then submits revised documents in line with EMA's recommendations and the Agency publishes the final version. The flowchart below summarises the process.