26 July 2017

In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.

The E19 Concept Paper and Business Plan are now available for download on the ICH website under the Efficacy section of the ICH website.