![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » EMA Issues Guidance for Submitting Clinical Data
EMA Issues Guidance for Submitting Clinical Data
![EMA_Logo.gif](https://www.fdanews.com/ext/resources/test/Drug-Images3/EMA_Logo.gif?t=1579219264&width=430)
March 9, 2016
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.
Upcoming Events
-
21Oct