EMA Issues Guidance for Submitting Clinical Data

Drugmakers submitting anonymous clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification.

In guidance dated March 2, the EMA addresses transparency policies for clinical reports included in marketing-authorization applications. The EMA will begin making these reports publicly available in September.

After submitting an application, drugmakers will be prompted to submit a redaction proposal package that describes how clinical data was made anonymous and how the risk of re-identification will be managed. Once the company submits the final package, the EMA will update the system and send an acknowledgment receipt and submission acceptance email before publication.